2010-08934_pi

8/9/2019 2010-08934_PI

1/24

Monday,

April 26, 2010

Part VII

Department ofHealth and HumanServicesSemiannual Regulatory Agenda

VerDate Nov2008 08:22 Apr 20, 2010 Jkt 220002 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 C:\UNIFIED\SPRING2010\UA100407.TXT JEFF PsN: UA100407

8/9/2019 2010-08934_PI

2/24

62 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010/ Unified Agenda

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II,III, and XIII

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulatory agenda

SUMMARY: The following Agendapresents the results of the statutorilyrequired semi-annual inventory ofrulemaking actions currently underdevelopment within the U.S.Department of Health and Human

Services (HHS). We hope that thisinformation will enable interestedmembers of the public to moreeffectively participate in the

Departments regulatory activity.FOR FURTHER INFORMATION CONTACT:Dawn L. Smalls, Executive Secretary,Department of Health and HumanServices, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: Theinformation provided in the Agendapresents a forecast of the rulemakingactivities that HHS expects to undertakein the foreseeable future. Rulemakingsare grouped according to pre-rulemaking actions, proposed rules,final rules, long-term actions, andrulemaking actions completed since themost recent Agenda was published onDecember 7, 2009. Please note that theactions included in this issue of theFederal Register, as required by the

Regulatory Flexibility Act of 1980, relateonly to those prospective rulemakingsthat are likely to have a significanteconomic impact on a substantial

number of small entities.The purpose of the Agenda is to

encourage more effective publicparticipation in the regulatory process.HHS invites all interested members ofthe public to comment on therulemaking actions included in thisissuance of the Agenda. The completeAgenda is accessible online atwww.reginfo.gov in an interactiveformat that offers users enhancedcapabilities to obtain information fromthe Agendas database.

Dated: March 10, 2010.

Dawn L. Smalls,Executive Secretary,

Department of Health and Human Services.

Office of the SecretaryProposed Rule Stage

SequenceNumber

TitleRegulationIdentifierNumber

120 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology

for Economic and Clinical Health Act .......................................................................................................................... 0991AB57

Office of the SecretaryFinal Rule Stage

SequenceNumber


121 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria

for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review) .......................... 0991AB58

Substance Abuse and Mental Health Services AdministrationFinal Rule Stage

SequenceNumber


122 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review) ...................... 0930AA14

Substance Abuse and Mental Health Services AdministrationLong-Term Actions

SequenceNumber


123 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities

for Children and Youth ................................................................................................................................................ 0930AA10


8/9/2019 2010-08934_PI

3/24

63Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010/ Unified Agenda

HHS

Centers for Disease Control and PreventionProposed Rule Stage

SequenceNumber


124 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Im-

portation Regulations ................................................................................................................................................... 0920AA14

125 Control of Communicable Diseases: Foreign Quarantine Regulations, Nonhuman Primate ....................................... 0920AA23

126 Total Inward Leakage Requirements for Respirators ................................................................................................... 0920AA33

Centers for Disease Control and PreventionFinal Rule Stage

SequenceNumber


127 Quality Assurance Requirements for Respirators ......................................................................................................... 0920AA04

128 Control of Communicable Diseases: Foreign Quarantine ............................................................................................ 0920AA12

Centers for Disease Control and PreventionLong-Term Actions

SequenceNumber


129 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 Review) ....................... 0920AA32

Centers for Disease Control and PreventionCompleted Actions

SequenceNumber


130 Control of Communicable Diseases: Interstate Quarantine, Passenger Information ................................................... 0920AA27

Food and Drug AdministrationPrerule Stage

SequenceNumber


131 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Dis-

tribution (Section 610 Review) ................................................................................................................................... 0910AG06

132 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and

Administrative Procedures (Section 610 Review) ...................................................................................................... 0910AG14

133 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 Review) ......................... 0910AG25

134 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and

Adolescents ................................................................................................................................................................. 0910AG33

135 Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review) ...................................................... 0910AG34

Food and Drug AdministrationProposed Rule Stage

SequenceNumber


136 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics ............................................... 0910AC52

137 Over-the-Counter (OTC) Drug ReviewCough/Cold (Antihistamine) Products .......................................................... 0910AF31

138 Over-the-Counter (OTC) Drug ReviewInternal Analgesic Products .......................................................................... 0910AF36

139 Over-the-Counter (OTC) Drug ReviewLaxative Drug Products ................................................................................ 0910AF38

140 Over-the-Counter (OTC) Drug ReviewSunscreen Products ..................................................................................... 0910AF43

141 Over-the-Counter (OTC) Drug ReviewTopical Antimicrobial Drug Products ............................................................ 0910AF69

142 Process Controls for Animal Feed Ingredients and Mixed Animal Feed ...................................................................... 0910AG10


8/9/2019 2010-08934_PI

4/24


HHS

Food and Drug AdministrationProposed Rule Stage (Continued)

SequenceNumber


143 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter

Human Use; Proposed Amendment of Final Monograph ........................................................................................... 0910AG12

144 Unique Device Identification .......................................................................................................................................... 0910AG31

145 Produce Safety Regulation ........................................................................................................................................... 0910AG35

146 Modernization of the Current Food Good Manufacturing Practices Regulation ........................................................... 0910AG36

147 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act .............................................................. 0910AG38

Food and Drug AdministrationFinal Rule Stage

SequenceNumber


148 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products .......................................... 0910AA97

149 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ................................... 0910AC53150 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and

Lactation Labeling ........................................................................................................................................................ 0910AF11

151 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements;

Records and Reports; and Quality Factors ................................................................................................................. 0910AF27

152 Over-the-Counter (OTC) Drug ReviewCough/Cold (Bronchodilator) Products ......................................................... 0910AF32

153 Over-the-Counter (OTC) Drug ReviewCough/Cold (Combination) Products ............................................................ 0910AF33

154 Over-the-Counter (OTC) Drug ReviewExternal Analgesic Products ......................................................................... 0910AF35

155 Over-the-Counter (OTC) Drug ReviewSkin Protectant Products .............................................................................. 0910AF42

156 Use of Materials Derived From Cattle in Human Food and Cosmetics ....................................................................... 0910AF47

157 Label Requirement for Food That Has Been Refused Admission Into the United States ........................................... 0910AF61

Food and Drug AdministrationLong-Term Actions

SequenceNumber

Title RegulationIdentifierNumber

158 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Sup-

plements ...................................................................................................................................................................... 0910AB88

159 Over-the-Counter (OTC) Drug ReviewCough/Cold (Nasal Decongestant) Products ............................................... 0910AF34

160 Over-the-Counter (OTC) Drug ReviewLabeling of Drug Products for OTC Human Use ......................................... 0910AF37

161 Over-the-Counter (OTC) Drug ReviewOphthalmic Products .................................................................................... 0910AF39

162 Over-the-Counter (OTC) Drug ReviewOral Health Care Products ........................................................................... 0910AF40

163 Over-the-Counter (OTC) Drug ReviewVaginal Contraceptive Products ................................................................... 0910AF44

164 Over-the-Counter (OTC) Drug ReviewWeight Control Products ............................................................................... 0910AF45

165 Over-the-Counter (OTC) Drug ReviewOverindulgence in Food and Drink Products ............................................... 0910AF51

166 Over-the-Counter (OTC) Drug ReviewAntacid Products ........................................................................................... 0910AF52

167 Over-the-Counter (OTC) Drug ReviewSkin Bleaching Products ............................................................................... 0910AF53

168 Over-the-Counter (OTC) Drug ReviewStimulant Drug Products ............................................................................... 0910AF56

169 Over-the-Counter Antidiarrheal Drug Products ............................................................................................................. 0910AF63

170 Over-the-Counter (OTC) Drug ReviewUrinary Analgesic Drug Products ................................................................. 0910AF70

171 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients ................................................... 0910AF95

Food and Drug AdministrationCompleted Actions

SequenceNumber


172 Positron Emission Tomography Drugs; Current Good Manufacturing Practices ......................................................... 0910AC55

173 Over-the-Counter (OTC) Drug ReviewAcne Drug Products Containing Benzoyl Peroxide ...................................... 0910AG00


8/9/2019 2010-08934_PI

5/24

8/9/2019 2010-08934_PI

6/24


Department of Health and Human Services (HHS) Final Rule Stage

Office of the Secretary (OS)

121. HEALTH INFORMATIONTECHNOLOGY: INITIAL SET OFSTANDARDS, IMPLEMENTATIONSPECIFICATIONS, ANDCERTIFICATION CRITERIA FOR

ELECTRONIC HEALTH RECORDTECHNOLOGY (RULEMAKINGRESULTING FROM A SECTION 610REVIEW)

Legal Authority: 42 USC 300jj14

Abstract: The Department of Healthand Human Services (HHS), Office ofthe National Coordinator for HealthInformation Technology, will issue aninterim final rule with a request forcomments to adopt an initial set ofstandards, implementation

specifications, and certification criteria,as required by section 3004(b)(1) of thePublic Health Service Act. Thecertification criteria adopted in thisinitial set establish the technical

capabilities and related standards thatcertified electronic health record (EHR)technology will need to include insupport of the Medicare and MedicaidEHR Incentive Programs.

Timetable:

Action Date FR Cite

Interim Final Rule 01/13/10 75 FR 2014

Interim Final RuleComment PeriodEnd

03/15/10

Action Date FR Cite

Interim Final RuleEffective

02/12/10

Final Action 05/00/10

Final Action Effective 06/00/10Regulatory Flexibility AnalysisRequired: No

Agency Contact: Steven Posnack,Policy Analyst, Department of Healthand Human Services, Office of theSecretary, Office of the NationalCoordinator for Health InformationTechnology, 200 Independence AvenueSW., Washington, DC 20201Phone: 202 6907151

RIN: 0991AB58


Substance Abuse and Mental Health Services Administration (SAMHSA)

122. OPIOID DRUGS INMAINTENANCE OR DETOXIFICATIONTREATMENT OF OPIATE ADDICTION(SECTION 610 REVIEW)

Legal Authority: 21 USC 823 (9); 42USC 257a; 42 USC 290aa(d); 42 USC290dd2; 42 USC 300xx23; 42 USC300x27(a); 42 USC 300y11

Abstract: This rule will amend theFederal opioid treatment programregulations. It will modify the

dispensing requirements for

buprenorphine and buprenorphinecombination products that are approved

by the Food and Drug Administration(FDA) for opioid dependence and usedin federally certified and registeredopioid treatment programs.

Timetable:

Action Date FR Cite

NPRM 06/19/09 74 FR 29153

NPRM CommentPeriod End

08/18/09


Regulatory Flexibility AnalysisRequired: No

Agency Contact: Nicholas Reuter,Department of Health and HumanServices, Substance Abuse and MentalHealth Services Administration, Suite21063, One Choke Cherry Road,Rockville, MD 20857Phone: 240 2762716

RIN: 0930AA14

Department of Health and Human Services (HHS) Long-Term Actions

Substance Abuse and Mental Health Services Administration (SAMHSA)

123. REQUIREMENTS GOVERNINGTHE USE OF SECLUSION ANDRESTRAINT IN CERTAINNONMEDICAL COMMUNITYBASEDFACILITIES FOR CHILDREN ANDYOUTH

Legal Authority: PL 106310, 42 USC290jj to 290jj2

Abstract: The Secretary is required bystatute to publish regulations governingStates that license nonmedical,community-based residential facilitiesfor children and youth. The regulationrequires States to develop licensing

rules and monitoring requirementsconcerning behavior managementpractice that will ensure compliance;requires States to develop andimplement such licensing rules andimplementation requirements withinone year; and ensures that Statesrequire such facilities to have adequatestaff, and that the States provide

training for professional staff.

Timetable:

Action Date FR Cite

NPRM To Be Determined

Regulatory Flexibility AnalysisRequired: Yes

Agency Contact: Paolo Del Vecchio,Department of Health and HumanServices, Substance Abuse and MentalHealth Services Administration, Room13103, Parklawn Building, 5600Fishers Lane, Rockville, MD 20857

Phone: 301 4432619

RIN: 0930AA10


8/9/2019 2010-08934_PI

7/24


Department of Health and Human Services (HHS) Proposed Rule Stage

Centers for Disease Control and Prevention (CDC)

124. CONTROL OF COMMUNICABLEDISEASES: FOREIGN QUARANTINEREGULATIONS, PROPOSED REVISIONOF HHS/CDC ANIMAL IMPORTATIONREGULATIONS

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary ofHealth and Human Services has broadauthority to prevent introduction,transmission, and spread ofcommunicable diseases from foreigncountries into the United States andfrom one State or possession intoanother. The Secretary has designatedthe authority to prevent theintroduction of diseases from foreigncountries to the Director, Centers forDisease Control and Prevention (CDC).CDC also enforces entry requirementsfor certain animals, etiologic agents,and vectors deemed to be of publichealth significance. Currently theregulations restrict the importation ofnonhuman primates, dogs, cats, smallturtles, etiologic agents, hosts, andvectors, such as bats (42 CFR sections71.53, 71.51, 71.52, 71.54). In addition,CDC has recently issued a series ofemergency orders restricting theimportation of African rodents (42 CFRsection 71.56) and civets (67 FR 3364-01). CDC is issuing this Notice ofProposed Rulemaking (NPRM) to revisethe regulations for importation ofcertain animals and vectors into the

United States (42 CFR parts 71, subpartF).

Timetable:

Action Date FR Cite

ANPRM 07/31/07 72 FR 41676

ANPRM CommentPeriod End

10/01/07

Notice ExtendingANPRM CommentPeriod

10/01/07 72 FR 55729

ANPRM ExtendedComment PeriodEnd

12/01/07

NPRM 11/00/10


Agency Contact: Stacy Howard,Department of Health and HumanServices, Centers for Disease Controland Prevention, MS E03, CLFTBuilding 16, Room 4324, Atlanta, GA

30329Phone: 404 4981600Email: [email protected]

RIN: 0920AA14

125. CONTROL OF COMMUNICABLEDISEASES: FOREIGN QUARANTINEREGULATIONS, NONHUMAN PRIMATE


Abstract: By statute, the Secretary ofHealth and Human Services has broadauthority to prevent introduction,transmission, and spread ofcommunicable diseases from foreign

countries into the United States andfrom one State or possession intoanother. The Secretary has delegatedthe authority to prevent theintroduction of diseases from foreigncountries to the Director, CDC. CDCalso enforces entry requirements forcertain animals, etiologic agents, andvectors deemed to be of public healthsignificance. CDC is proposing toamend its regulations related to theimportation of live nonhuman primates(NHPs) by extending existingrequirements for the importation ofcynomolgus, African green, and rhesus

monkeys to all NHPs. The agency alsois proposing to reduce the frequencyat which importers of the three speciesare required to renew their registrations(from every 180 days to every 2 years).CDC proposes to incorporate existingguidelines into the regulations and addnew provisions to address NHPsimported as part of a circus or trainedanimal act, NHPs imported byzoological societies, the transfer ofNHPs from approved laboratories, andnon-live imported NHP products. CDCis also proposing that all NHPs beimported only through ports of entrywhere a CDC quarantine station islocated.

Timetable:

Action Date FR Cite

NPRM 08/00/10


Agency Contact: Stacy Howard,Department of Health and HumanServices, Centers for Disease Controland Prevention, MS E03, CLFTBuilding 16, Room 4324, Atlanta, GA30329Phone: 404 4981600Email: [email protected]

RIN: 0920AA23

126. TOTAL INWARD LEAKAGEREQUIREMENTS FOR RESPIRATORS

Legal Authority: 29 USC 651 et seq;29 USC 657(g); 30 USC 3; 30 USC 7;30 USC 811; 30 USC 842(h) and 844

Abstract: The Centers for DiseaseControl and Prevention (CDC) proposesto establish total inward leakage (TIL)requirements under 42 CFR part 84 forhalf-mask air-purifying particulaterespirators approved by the NationalInstitute for Occupational Safety andHealth (NIOSH) of CDC.

Timetable:

Action Date FR Cite

NPRM 10/30/09 74 FR 66935NPRM Comment

Period End12/29/09

NPRM CommentPeriod Reopened

04/00/10


Agency Contact: William E. Newcomb,Physical Scientist, Department ofHealth and Human Services, Centers forDisease Control and Prevention, 626Cochran Mill Road, PO Box 18070,Pittsburgh, PA 15236Phone: 412 3865200

RIN: 0920AA33



127. QUALITY ASSURANCEREQUIREMENTS FOR RESPIRATORS

Legal Authority: 29 USC 651 et seq;30 USC 3; 30 USC 5; 30 USC 7; 30USC 811; 30 USC 842(h); 30 USC 844

Abstract: NIOSH plans to modify theAdministrative/Quality Assurancesections of 42 CFR part 84, Approvalof Respiratory Protective Devices. Areasfor potential modification in thismodule are: 1) Upgrade of quality

assurance requirements; 2) ability touse private sector quality auditors andprivate sector testing laboratories in theapproval program; and 3) revisedapproval label requirements.


8/9/2019 2010-08934_PI

8/24


HHSCDC Final Rule Stage

Timetable:

Action Date FR Cite

NPRM 12/10/08 73 FR 75045

NPRM Comment

Period End

02/09/09


03/04/09 74 FR 9381

NPRM CommentPeriod ReopenedEnd

04/10/09

NPRM CommentPeriod ReopeningExtended

05/21/09 74 FR 23815


10/09/09



Agency Contact: William E. Newcomb,Physical Scientist, Department ofHealth and Human Services, Centers forDisease Control and Prevention, 626Cochran Mill Road, PO Box 18070,Pittsburgh, PA 15236Phone: 412 3865200

RIN: 0920AA04

128. CONTROL OF COMMUNICABLEDISEASES: FOREIGN QUARANTINE

Legal Authority: 42 USC 243; 42 USC248 and 249

Abstract: By statute, the Secretary ofHealth and Human Services has broadauthority to prevent introduction,transmission, and spread ofcommunicable diseases from foreigncountries into the United States andfrom one State or possession intoanother. Quarantine regulations aredivided into two parts: Part 71 dealingwith foreign arrivals and part 70dealing with interstate matters. Thisrule (42 CFR part 71) will update andimprove CDCs response to both globaland domestic disease threats bycreating a multi-tiered illness detectionand response process thus substantiallyenhancing the public health systemsability to slow the introduction,transmission, and spread ofcommunicable disease. The rule willalso modify current Federal regulationsgoverning the apprehension, quarantineisolation, and conditional release ofindividuals suspected of carrying aquarantinable disease, while respectingindividual autonomy. CDC maintainsquarantine stations at 20 ports of entrystaffed with medical and public healthofficers who respond to reports ofdiseases from carriers. According to thestatutory scheme, the Presidentdetermines through Executive Order

which diseases may subject individualsto quarantine. The current disease list,which was last updated in April 2005,includes cholera, diphtheria,tuberculosis, plague, smallpox, yellowfever, viral hemorrhagic fevers, severeacute respiratory syndrome (SARS), andinfluenza caused by novel orreemergent influenza viruses that arecausing, or have the potential to causea pandemic.

Timetable:

Action Date FR Cite

NPRM 11/30/05 70 FR 71892


01/20/06



Agency Contact: Stacy Howard,Department of Health and HumanServices, Centers for Disease Controland Prevention, MS E03, CLFTBuilding 16, Room 4324, Atlanta, GA30329Phone: 404 4981600Email: [email protected]

RIN: 0920AA12



129. POSSESSION, USE, ANDTRANSFER OF SELECT AGENTS ANDTOXINS: CHAPARE VIRUS (SECTION610 REVIEW)

Legal Authority: PL 107188

Abstract: The Public Health Securityand Bioterrorism Preparedness andResponse Act of 2002 authorizes theHHS Secretary to regulate thepossession, use, and transfer of selectagents and toxins that have thepotential to pose a severe threat topublic health and safety. Theseregulations are set forth at 42 CFR 73.Criteria used to determine whether aselect agent or toxin should beincluded under the provisions of theseregulations are based on: 1) The effecton human health as a result ofexposure to the agent or toxin, 2) thedegree of contagiousness of the agentor toxin, 3) the methods by which theagent or toxin is transferred to humans,4) the availability and effectiveness ofpharmacotherapies and immunizations

to treat and prevent and illnessresulting from infection by the agent ortoxin, and 5) any other criteria,including the needs of children andother vulnerable populations that theHHS Secretary considers appropriate.Based on these criteria, we areproposing to amend the list of HHSselect agents and toxins by addingChapare virus to the list. Afterconsulting with subject matter expertsfrom CDC, the National Institutes ofHealth (NIH), the Food DrugAdministration (FDA), the UnitedStates Department of Agriculture(USDA) /Animal and Plant HealthInspection Service (APHIS),USDA/Agricultural Research Service(ARS), USDA/CVB (Center forVeterinary Biologics), and theDepartment of Defense (DOD)/UnitedStates Army Medical Research Institutefor Infectious Diseases (USAMRIID) andreview of relevant published studies,we believe the Chapare virus should beadded to the list of HHS select agents

and toxins based on our conclusionthat the Chapare virus has beenphylogenetically identified as a CladeB arenavirus and is closely related toother South American arenaviruses thatcause haemorrhagic fever, particularlySabia virus.

Timetable:

Action Date FR Cite

NPRM 08/19/09 74 FR 159

NPRM Comment

Period End

10/19/09

Final Action To Be Determined


Agency Contact: Robbin Weyant,Department of Health and HumanServices, Centers for Disease Controland Prevention, CLFT Building 20,Room 4202, 1600 Clifton Road NE.,Atlanta, GA 30333Phone: 404 7182000

RIN: 0920AA32


8/9/2019 2010-08934_PI

9/24


Department of Health and Human Services (HHS) Completed Actions


130. CONTROL OF COMMUNICABLEDISEASES: INTERSTATEQUARANTINE, PASSENGERINFORMATION

Legal Authority: 25 USC 198.231; 25USC 1661; 42 USC 243; 42 USC 248;42 USC 249; 42 USC 264; 42 USC 266to 268; 42 USC 270 to 272; 42 USC2001

Abstract: By statute, the Secretary ofHealth and Human Services has broadauthority to prevent introduction,transmission, and spread ofcommunicable diseases from one Stateor possession into another. Quarantineregulations are divided into two parts:Part 71 dealing with foreign arrivalsand part 70 dealing with interstatematters. The CDC Director has been

delegated the responsibility for carryingout these regulations. The Directors

authority to investigate suspected casesand potential spread of communicabledisease among interstate travelers isthus not limited to those known orsuspected of having a quarantinable

disease, but rather all communicablediseases that may necessitate a publichealth response.

Among the fundamental components ofthe public health response to the reportof a person with a communicabledisease is the identification andevaluation of individuals who mayhave been exposed. This provision,which was proposed section 70.4,would require any airline operating ininterstate traffic to solicit andelectronically submit certain passengerinformation to CDC for use in contact

tracing when necessary to protect thevital interests of an individual, or other

persons, in regard to significant healthrisks.

Timetable:

Action Date FR Cite

NPRM 11/30/05 70 FR 71892


01/30/06

Merged With0920AA22

02/12/10


Agency Contact: Stacy Howard,Department of Health and HumanServices, Centers for Disease Controland Prevention, MS E03, CLFTBuilding 16, Room 4324, Atlanta, GA30329Phone: 404 4981600

Email: [email protected]: 0920AA27

Department of Health and Human Services (HHS) Prerule Stage

Food and Drug Administration (FDA)

131. FOOD LABELING: SAFEHANDLING STATEMENTS, LABELINGOF SHELL EGGS; REFRIGERATIONOF SHELL EGGS HELD FOR RETAILDISTRIBUTION (SECTION 610REVIEW)

Legal Authority: 15 USC 1453 to 1455;

21 USC 321; 21 USC 331; 21 USC 342and 343; 21 USC 348; 21 USC 371; 42USC 243; 42 USC 264; 42 USC 271

Abstract: Section 101.17(h) (21 CFR101.17(h)) describes requirements forthe labeling of the cartons of shell eggsthat have not been treated to destroySalmonella microorganisms. Section115. 50 (21 CFR 115.50) describesrequirements for refrigeration of shelleggs held for retail distribution. Section16.5(a)(4) (21 CFR 16.5(a)(4)) providesthat part 16 does not apply to a hearingon an order for relabeling, diversion,or destruction of shell eggs under

section 361 of the Public Health ServiceAct (42 U.S.C. 264) and sections101.17(h) and 115.50. FDA amended 21CFR 101.17(h) on August 20, 2007 (72FR 46375) to permit the safe handlingstatement to appear on the inside lidof egg cartons to provide the industrygreater flexibility in the placement ofthe statement. FDA is undertaking areview of 21 CFR sections 101.17(h),115.50, and 16.5(a)(4) under section610 of the Regulatory Flexibility Act.The purpose of this review is todetermine whether the regulations in

sections 101.17(h), 115.50 and16.5(a)(4) should be continued withoutchange, or whether they should beamended or rescinded, consistent withthe stated objectives of applicablestatutes, to minimize any significanteconomic impact on a substantialnumber of small entities. FDA willconsider, and is soliciting commentson, the following: (1) The continuedneed for the rule; (2) the nature ofcomplaints or comments receivedconcerning the rule from the public; (3)the complexity of the rule; (4) theextent to which the rule overlaps,duplicates, or conflicts with otherFederal rules, and, to the extentfeasible, with State and localgovernmental rules; and (5) the lengthof time since the rule has beenevaluated or the degree to whichtechnology, economic conditions, orother factors have changed in the area

affected by the rule.Timetable:

Action Date FR Cite

Begin Review 12/15/09

End Review 12/00/10

Regulatory Flexibility AnalysisRequired: Undetermined

Agency Contact: Geraldine A. June,Supervisor, Product Evaluation andLabeling Team, Department of Healthand Human Services, Food and DrugAdministration, Center for Food Safety

and Applied Nutrition, (HFS820),5100 Paint Branch Parkway, CollegePark, MD 20740Phone: 301 4361802Fax: 301 4362636Email: [email protected]

RIN: 0910AG06

132. PRESCRIPTION DRUGMARKETING ACT OF 1987;PRESCRIPTION DRUG AMENDMENTSOF 1992; POLICIES, REQUIREMENTS,AND ADMINISTRATIVE PROCEDURES(SECTION 610 REVIEW)

Legal Authority: 21 USC 331; 21 USC333; 21 USC 351; 21 USC 352; 21 USC353; 21 USC 360; 21 USC 371; 21 USC374; 21 USC 381

Abstract: FDA is undertaking a reviewof 21 CFR part 203 and 21 CFR sections205.3 and 205.50 (as amended in 64

FR 67762 and 67763) under section 610of the Regulatory Flexibility Act. Thepurpose of this review is to determinewhether the regulations in 21 CFR part203 and 21 CFR sections 205.3 and205.50 (as amended in 64 FR 67762and 67763) should be continuedwithout change, or whether they should

be amended or rescinded, consistentwith the stated objectives of applicablestatutes, to minimize adverse impactson a substantial number of smallentities. FDA will consider, and issoliciting comments on, the following:


8/9/2019 2010-08934_PI

10/24


HHSFDA Prerule Stage

(1) The continued need for theregulations in 21 CFR part 203 and 21CFR sections 205.3 and 205.50 (asamended in 64 FR 67762 and 67763);(2) the nature of complaints or

comments received from the publicconcerning the regulations in 21 CFRpart 203 and 21 CFR sections 205.3 and205.50 (as amended in 64 FR 67762and 67763); (3) the complexity of theregulations in 21 CFR part 203 and 21CFR sections 205.3 and 205.50 (asamended in 64 FR 67762 and 67763);(4) the extent to which the regulationsin 21 CFR part 203 and 21 CFR sections205.3 and 205.50 (as amended in 64FR 67762 and 67763) overlap,duplicate, or conflict with other Federalrules, and to the extent feasible, withState and local governmental rules; and

(5) the degree to which technology,economic conditions, or other factorshave changed in the area affected bythe regulations in 21 CFR part 203 and21 CFR sections 205.3 and 205.50 (asamended in 64 FR 67762 and 67763).

Timetable:

Action Date FR Cite

Begin Review ofCurrent Regulation

11/24/08

End Review of CurrentRegulation

06/00/10


Agency Contact: Howard Muller,Office of Regulatory Policy, Departmentof Health and Human Services, Foodand Drug Administration, Center forDrug Evaluation and Research, WO 51,Room 6234, 10903 New HampshireAvenue, Silver Spring, MD 209930002Phone: 301 7963601Fax: 301 8478440Email: pdma610(c)[email protected]

RIN: 0910AG14

133. STERILITY REQUIREMENT FORAQUEOUSBASED DRUG PRODUCTS

FOR ORAL INHALATION (SECTION610 REVIEW)

Legal Authority: 21 USC 321; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 358; 21 USC 360e; 21 USC 371;21 USC 374; 21 USC 375

Abstract: FDA is undertaking a reviewof 21 CFR 200.51, under section 610of the Regulatory Flexibility Act. Thepurpose of this review is to determinewhether this regulation on aqueous-

based drug products for oral inhalationshould be continued without change, or

whether it should be amended orrescinded, consistent with the statedobjectives of applicable statues, tominimize adverse impacts on asubstantial number of small entities.

FDA will consider, and is solicitingcomments on the following: (1) Thecontinued need for 21 CFR 200.51; (2)the nature of complaints or commentsreceived concerning 21 CFR 200.51; (3)the complexity of 21 CFR 200.51; (4)the extent to which the regulationoverlaps, duplicates, or conflicts withother Federal, State, or governmentalrules; and (5) the degree to whichtechnology, economic conditions, orother factors have changed in the areaaffected by 21 CFR 200.51.

Timetable:

Action Date FR CiteBegin Review 05/01/09

End Review 05/00/10


Agency Contact: Howard P. Muller,Office of Regulatory Policy, Departmentof Health and Human Services, Foodand Drug Administration, Center forDrug Evaluation and Research, WO 51,Room 6234, 10903 New HampshireAvenue, Silver Spring, MD 209930002Phone: 301 7963601Fax: 301 8478440Email: [email protected]

RIN: 0910AG25

134. REGULATIONS RESTRICTINGTHE SALE AND DISTRIBUTION OFCIGARETTES AND SMOKELESSTOBACCO TO PROTECT CHILDRENAND ADOLESCENTS

Legal Authority: 21 USC 301 et seq,The Federal Food, Drug, and CosmeticAct; PL 11131, Family SmokingPrevention and Tobacco Control Act

Abstract: This rule establishesregulations restricting the sale and

distribution of cigarettes and smokelesstobacco to children and adolescents,implementing section 102 of the FamilySmoking Prevention and TobaccoControl Act (FSPTCA). FSPTCAsections 102 and 6(c)(1) require theSecretary to publish, within 270 daysof enactment, a final rule regardingcigarettes and smokeless tobacco. Thisfinal rule must be identical, except forseveral changes identified in section102(a)(2) of FSPTCA, to part 897 of theregulations promulgated by theSecretary of HHS in the August 28,

1996, issue of the Federal Register (61FR 44396).

This final rule prohibits the sale ofcigarettes and smokeless tobacco to

individuals under the age of 18 andrequires manufacturers, distributors,and retailers to comply with certainconditions regarding access to, andpromotion of, these products. Amongother things, the final rule requiresretailers to verify a purchasers age byphotographic identification. It alsoprohibits, with limited exception, freesamples and prohibits the sale of theseproducts through vending machinesand self-service displays except infacilities where individuals under theage of 18 are not present or permittedat any time. The rule also limits the

advertising and labeling to whichchildren and adolescents are exposed.The rule accomplishes this by generallyrestricting advertising to whichchildren and adolescents are exposedto a black-and-white, text-only format.The rule also prohibits the sale ordistribution of brand-identifiedpromotional, non-tobacco items such ashats and tee shirts. Furthermore, therule prohibits sponsorship of sportingand other events, teams, and entries ina brand name of a tobacco product, butpermits such sponsorship in acorporate name.

FDA will also publish in the same issueof the Federal Register an advancenotice of proposed rulemakingrequesting comments, data, research, orother information on the regulation ofoutdoor advertising of cigarettes andsmokeless tobacco.

Timetable:

Action Date FR Cite

ANPRM 03/19/10 75 FR 13241

Final Rule 03/19/10 75 FR 13225


05/18/10

Final Rule Effective 06/22/10


Agency Contact: Annette L. Marthaler,Regulatory Counsel, Department ofHealth and Human Services, Food andDrug Administration, 9200 CorporateBoulevard, 100K, Rockville, MD 20850Phone: 877 2871373Fax: 240 2763904Email: [email protected]

RIN: 0910AG33


8/9/2019 2010-08934_PI

11/24


HHSFDA Prerule Stage

135. OVERTHECOUNTER HUMANDRUGS; LABELING REQUIREMENTS(SECTION 610 REVIEW)


Abstract: Part 201.66 (21 CFR section201.66) established a standardizedformat for the labeling of OTC drugproducts that included: (1) Specificheadings and subheadings presented ina standardized order, (2) standardizedgraphical features such as Helveticatype style and the use of bulletpoints to introduce key information,and (3) minimum standards for typesize and spacing. FDA issued the finalrule to improve labeling afterconsidering comments submitted to theagency following the publication of theproposed regulation in 1997. In 1999,FDA published the final rule and statedthat a standardized labeling formatwould significantly improve readability

by familiarizing consumers with thetypes of information in OTC drugproduct labeling and the location ofthat information. In addition, astandardized appearance andstandardized content, including varioususer-friendly visual cues, would helpconsumers locate and read importanthealth and safety information and allowquick and effective productcomparisons, thereby helping

consumers to select the mostappropriate product.

FDA is initiating a review undersection 610 of the Regulatory Flexibility

Act for the regulation in part 201.66.The purpose of this review is todetermine whether the regulation inpart 201.66 should be continuedwithout change, or whether it should

be further amended or rescinded,consistent with the stated objectives ofapplicable statutes, to minimize adverseimpacts on a substantial number ofsmall entities. FDA will consider, andis soliciting comments on thefollowing: (1) The continued need forthe regulation in part 201.66; (2) thenature of the complaints or commentsreceived concerning the regulation inpart 201.66; (3) the complexity of the

regulations in part 201.66; (4) theextent to which the regulations in part201.66 overlap, duplicate, or conflictwith other Federal, State, orgovernmental rules; and (5) the degreeto which technology, economicconditions, or other factors havechanged for the products still subjectto the labeling standard regulations inpart 201.

The section 610 review will be carriedout along with a regulatory reviewunder section 5 of Executive Order

12866, which calls for agencies toperiodically review existing regulationsto determine whether any should bemodified or eliminated so as to makethe agencys regulatory program more

effective in achieving its goals, lessburdensome, or in greater alignmentwith the Presidents priorities and theprinciples set forth in the Executiveorder.

Timetable:

Action Date FR Cite

Begin Review ofCurrent Regulation

08/03/09

End Review of CurrentRegulation

05/00/10


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and HumanServices, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AG34

Department of Health and Human Services (HHS) Proposed Rule StageFood and Drug Administration (FDA)

136. ELECTRONIC SUBMISSION OFDATA FROM STUDIES EVALUATINGHUMAN DRUGS AND BIOLOGICS

Legal Authority: 21 USC 355; 21 USC371; 42 USC 262

Abstract: The Food and DrugAdministration is proposing to amendthe regulations governing the format inwhich clinical study data and

bioequivalence data are required to besubmitted for new drug applications

(NDAs), biological license applications(BLAs), and abbreviated new drugapplications (ANDAs). The proposalwould revise our regulations to requirethat data submitted for NDAs, BLAs,and ANDAs, and their supplements andamendments, be provided in anelectronic format that FDA can process,review, and archive.

Timetable:

Action Date FR Cite

NPRM 10/00/10


Agency Contact: Martha Nguyen,Regulatory Counsel, Department ofHealth and Human Services, Food andDrug Administration, Center for DrugEvaluation and Research, WO 51, Room6352, 10903 New Hampshire Avenue,Silver Spring, MD 209930002Phone: 301 7963471Fax: 301 8478440

Email: [email protected]: 0910AC52

137. OVERTHECOUNTER (OTC)DRUG REVIEWCOUGH/COLD(ANTIHISTAMINE) PRODUCTS

Legal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 360; 21 USC 371

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generally

recognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. This action addressesantihistamine labeling claims for thecommon cold.

Timetable:

Action Date FR Cite

Reopening ofAdministrativeRecord

08/25/00 65 FR 51780

NPRM (Amendment)(Common Cold)

03/00/11


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and HumanServices, Food and DrugAdministration, Center for Drug


8/9/2019 2010-08934_PI

12/24


HHSFDA Proposed Rule Stage

Evaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899

Email: [email protected]

RIN: 0910AF31

138. OVERTHECOUNTER (OTC)DRUG REVIEWINTERNALANALGESIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 360; 21 USC 371; 21 USC 374;21 USC 379e


recognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The first action addressesproducts labeled to relieve upsetstomach associated withoverindulgence in food and drink andto relieve symptoms associated with ahangover. The second action addressesacetaminophen safety. The third actionaddresses products marketed forchildren under 2 years old and weight-

and age-based dosing for childrensproducts. The fourth action addressescombination products containing theanalgesic acetaminophen or aspirin andsodium bicarbonate used as an antacidingredient. The last document finalizesthe Internal Analgesic Productsmonograph.

Timetable:

Action Date FR Cite

NPRM (Amendment)(Required Warningsand Other Labeling)

12/26/06 71 FR 77314


05/25/07

NPRM (Over-indulgence/Hangover)

To Be Determined

Final Action (RequiredWarnings and OtherLabeling)

04/29/09 74 FR 19385

Final Action(Correction)

06/30/09 74 FR 31177

Final Action (TechnicalAmendment)

11/25/09 74 FR 61512

NPRM(Acetaminophen)

03/00/11

NPRM (Amendment)(Pediatric)

To Be Determined

Action Date FR Cite

NPRM (Amendment)(SodiumBicarbonate)

To Be Determined

Final Action (InternalAnalgesics) To Be Determined



RIN: 0910AF36

139. OVERTHECOUNTER (OTC)DRUG REVIEWLAXATIVE DRUGPRODUCTS

Legal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 360 to 360a; 21 USC 371 to371a

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The first NPRM listed willaddress the professional labeling forsodium phosphate drug products. Thesecond NPRM listed will address allother professional labelingrequirements for laxative drugproducts. The final action will addresslaxative drug products.

Timetable:

Action Date FR Cite

Final Action (GranularPsyllium)

03/29/07 72 FR 14669

NPRM (ProfessionalLabelingSodiumPhosphate)

10/00/10

NPRM (ProfessionalLabeling)

To Be Determined

Final Action (LaxativeDrug Products)

To Be Determined


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,

Department of Health and HumanServices, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New Hampshire

Avenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF38

140. OVERTHECOUNTER (OTC)DRUG REVIEWSUNSCREENPRODUCTS


Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The first action addressesactive ingredients reviewed under Timeand Extent Applications. The secondaction addresses other effectivenessissues for OTC sunscreen drugproducts. The third action finalizessunscreen formulation, labeling, andtesting requirements for both ultraviolet

B and ultraviolet A radiationprotection. The last action addressescombination products containingsunscreen and insect repellentingredients.

Timetable:

Action Date FR Cite

ANPRM (Sunscreenand InsectRepellent)

02/22/07 72 FR 7941


05/23/07

NPRM (UVA/UVB) 08/27/07 72 FR 49070


12/26/07

NPRM (Time andExtent Applications)

07/00/10

NPRM (Effectiveness) 10/00/10

Final Action(UVA/UVB)

10/00/10

NPRM (Sunscreenand InsectRepellent)

To Be Determined


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and Human


8/9/2019 2010-08934_PI

13/24



Services, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993

Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF43

141. OVERTHECOUNTER (OTC)DRUG REVIEWTOPICALANTIMICROBIAL DRUG PRODUCTS



recognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The first action addressesfood handler products. The secondaction addresses testing requirementsfor healthcare professional products.The third action addresses the safetyand effectiveness of consumer products.The final actions listed will address thehealthcare, consumer, and first aidantiseptic drug products respectively.

Timetable:

Action Date FR Cite

NPRM (Healthcare) 06/17/94 59 FR 31402

NPRM (FoodHandlers)

To Be Determined

NPRM (Testing HealthcareProfessionalProducts)

To Be Determined

NPRM (Consumer) 03/00/11

Final Action(Healthcare)

To Be Determined

Final Action(Consumer)

To Be Determined

Final Action (First Aid

Antiseptic)

To Be Determined


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and HumanServices, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899

Email: [email protected]

RIN: 0910AF69

142. PROCESS CONTROLS FORANIMAL FEED INGREDIENTS ANDMIXED ANIMAL FEED

Legal Authority: 21 USC 342; 21 USC350e; 21 USC 371; 21 USC 374; 42 USC264; PL 11085, sec 1002(a)(2)

Abstract: The Food and DrugAdministration (FDA) is proposingregulations for process controls foranimal feed ingredients and mixedanimal feed to provide greaterassurance that marketed animal feedingredients and mixed feeds intendedfor all animals, including pets, are safe.This action is being taken as part ofthe FDAs Animal Feed Safety Systeminitiative. The proposed processcontrols will apply to animal feedingredients and mixed animal feed,including pet food. This action is also

being taken to carry out therequirements of the Food and DrugAdministration Amendments Act of2007. Section 1002(a) directs FDA toestablish by regulation processingstandards for pet food. This sameprovision of the law also directs that,in developing these new regulations,

FDA obtain input from its stakeholders,including the Association of AmericanFeed Control Officials, veterinarymedical associations, animal healthorganizations, and pet foodmanufacturers.

Timetable:

Action Date FR Cite

NPRM 03/00/11


06/00/11


Agency Contact: Kim Young, DeputyDirector, Division of Compliance,Department of Health and HumanServices, Food and DrugAdministration, Center for VeterinaryMedicine, Room 106 (MPN4,HFV230), 7519 Standish Place,Rockville, MD 20855Phone: 240 2769207Email: [email protected]

RIN: 0910AG10

143. PEDIATRIC DOSING FORCOUGH, COLD, ALLERGY,BRONCHODILATOR, ANDANTIASTHMATIC DRUG PRODUCTSFOR OVERTHECOUNTER HUMAN

USE; PROPOSED AMENDMENT OFFINAL MONOGRAPH

Legal Authority: 21 USC 331; 21 USC351 to 353; 21 USC 355; 21 USC 360;21 USC 371

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a monograph isissued, only OTC drugs meeting theconditions of the monograph, or havingan approved new drug application, may

be legally marketed. This action will

propose changes to the final monographto address safety and efficacy issuesassociated with pediatric cough andcold products.

Timetable:

Action Date FR Cite

NPRM 12/00/10



RIN: 0910AG12

144. UNIQUE DEVICE IDENTIFICATION

Legal Authority: Not Yet Determined

Abstract: The Food and Drug

Administration Amendments Act of2007, amended the Federal Food, Drug,and Cosmetic Act by adding section519(f) (21 USC 360i(f)). This sectionrequires FDA to promulgate regulationsestablishing a unique identificationsystem for medical devices requiringthe label of medical devices to bear aunique identifier, unless FDA specifiesan alternative placement or provides forexceptions. The unique identifier mustadequately identify the device throughdistribution and use, and may includeinformation on the lot or serial number.


8/9/2019 2010-08934_PI

14/24



Timetable:

Action Date FR Cite

NPRM 12/00/10

Regulatory Flexibility Analysis

Required: Yes

Agency Contact:John J. Crowley,Senior Advisor for Patient Safety,Department of Health and HumanServices, Food and DrugAdministration, Center for Devices andRadiological Health, WO 66, Room2315, 10903 New Hampshire Avenue,Silver Spring, MD 20993Phone: 301 9801936Email: [email protected]

RIN: 0910AG31

145. PRODUCE SAFETY REGULATION


Abstract: The Food and DrugAdministration (FDA) has determinedthat enforceable standards (as opposedto voluntary recommendations) for theproduction and packing of freshproduce are necessary to ensure bestpractices are commonly adopted. FDAis proposing to promulgate regulationssetting enforceable standards for freshproduce safety at the farm and packinghouse. The purpose of the proposedrule is to reduce the risk of illnessassociated with contaminated freshproduce. The proposed rule will be

based on prevention-oriented publichealth principles and incorporate whatwe have learned in the past decadesince the agency issued general goodagricultural practice guidelines entitledGuide to Minimize Microbial FoodSafety Hazards for Fresh Fruits andVegetables (GAPs Guide). Theproposed rule also will reflectcomments received on the agencys1998 update of its GAPs guide and its

July 2009 draft commodity specificguidances for tomatoes, leafy greens,and melons. Although the proposed

rule will be based on recommendationsthat are included in the GAPs guide,FDA does not intend to make the entireguidance mandatory. FDAs proposedrule would, however, set out clearstandards for implementation ofmodern preventive controls. Theproposed rule also would emphasizethe importance of environmentalassessments to identify hazards and

possible pathways of contaminationand provide examples of risk reductionpractices recognizing that operatorsmust tailor their preventive controls toparticular hazards and conditions

affecting their operations. Therequirements of the proposed rulewould be scale appropriate andcommensurate with the relative risksand complexity of individualoperations. FDA intends to issueguidance after the proposed rule isfinalized to assist industry incomplying with the requirements of thenew regulation.

Timetable:

Action Date FR Cite

NPRM 12/00/10


Required: YesAgency Contact: Samir Assar,Department of Health and HumanServices, Food and DrugAdministration, Center for Food Safetyand Applied Nutrition, Office of FoodSafety, 5100 Paint Branch Parkway,College Park, MD 20740Phone: 301 4361636Email: [email protected]

RIN: 0910AG35

146. MODERNIZATION OF THECURRENT FOOD GOOD

MANUFACTURING PRACTICESREGULATION


Abstract: The Food and DrugAdministration (FDA) is proposing toamend its current good manufacturingpractices (CGMP) regulations (21 CFRpart 110) for manufacturing, packing, orholding human food. This proposedrule would require food facilities toaddress issues such as environmentalpathogens, food allergens, mandatoryemployee training, and sanitation offood contact surfaces. The proposed

rule also would require food facilitiesto develop and implement preventivecontrol systems. FDA is taking thisaction to better address changes thathave occurred in the food industry andprotect public health.

Timetable:

Action Date FR Cite

NPRM 03/00/11


Agency Contact: Paul South,Department of Health and Human

Services, Food and DrugAdministration, Center for Food Safetyand Applied Nutrition (HFS317),Office of Food Safety, 5100 PaintBranch Parkway, College Park, MD20740Phone: 301 4361640Email: [email protected]

RIN: 0910AG36

147. CIGARS SUBJECT TO THEFAMILY SMOKING PREVENTION ANDTOBACCO CONTROL ACT

Legal Authority: 21 USC 301 et seq,The Federal Food, Drug, and CosmeticAct; PL 11131, The Family SmokingPrevention and Tobacco Control Act

Abstract: The Family SmokingPrevention and Tobacco Control Act(the Tobacco Control Act) providesFDA authority to regulate cigarettes,cigarette tobacco, roll-your-owntobacco, and smokeless tobacco.Section 901 of the Federal Food, Drug,and Cosmetic Act, as amended by theTobacco Control Act, permits FDA toissue regulations deeming other tobaccoproducts to be subject to the TobaccoControl Act. This proposed rule woulddeem cigars to be subject to theTobacco Control Act and includeprovisions to address public healthconcerns raised by cigars.

Timetable:

Action Date FR Cite

NPRM 06/00/10


Agency Contact: May Nelson,Regulatory Counsel, Department ofHealth and Human Services, Food andDrug Administration, Center for FoodSafety and Applied Nutrition, 5100Paint Branch Parkway, College Park,MD 20740Phone: 877 2871373Fax: 301 4362637Email: [email protected]

RIN: 0910AG38


8/9/2019 2010-08934_PI

15/24




148. POSTMARKETING SAFETYREPORTING REQUIREMENTS FORHUMAN DRUG AND BIOLOGICALPRODUCTS

Legal Authority: 42 USC 216; 42 USC241; 42 USC 242a; 42 USC 262 and263; 42 USC 263a to 263n; 42 USC 264;42 USC 300aa; 21 USC 321; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 360; 21 USC 360b to 360j; 21USC 361a; 21 USC 371; 21 USC 374;21 USC 375; 21 USC 379e; 21 USC 381

Abstract: The final rule would amendthe postmarketing expedited andperiodic safety reporting regulations forhuman drugs and biological productsto revise certain definitions andreporting formats as recommended by

the International Conference onHarmonisation and to define newterms; to add to or revise currentreporting requirements; to revise certainreporting time frames; and to proposeother revisions to these regulations toenhance the quality of safety reportsreceived by FDA. These revisions wereproposed as part of a single rulemaking(68 FR 12406) to clarify and revise bothpremarketing and postmarketing safetyreporting requirements for human drugand biological products. FDA plans tofinalize the premarket and postmarketsafety reporting requirements in

separate final rules.Timetable:

Action Date FR Cite

NPRM 03/14/03 68 FR 12406

NPRM CommentPeriod Extended

06/18/03


07/14/03

NPRM CommentPeriod ExtensionEnd

10/14/03



Required: YesAgency Contact:Jane E. Baluss,Regulatory Counsel, Department ofHealth and Human Services, Food andDrug Administration, Center for DrugEvaluation and Research, WO 51, Room6362, 10903 New Hampshire Avenue,Silver Spring, MD 209930002Phone: 301 7963469Fax: 301 8478440Email: [email protected]

RIN: 0910AA97

149. MEDICAL GAS CONTAINERSAND CLOSURES; CURRENT GOODMANUFACTURING PRACTICEREQUIREMENTS

Legal Authority: 21 USC 321; 21 USC351 to 21 USC 353

Abstract: The Food and DrugAdministration is amending its currentgood manufacturing practiceregulations and other regulations toclarify and strengthen requirements forthe label, color, dedication, and designof medical gas containers and closures.Despite existing regulatoryrequirements and industry standardsfor medical gases, there have beenrepeated incidents in which cryogeniccontainers of harmful industrial gases

have been connected to medical oxygensupply systems in hospitals andnursing homes and subsequentlyadministered to patients. Theseincidents have resulted in death andserious injury. There have also beenseveral incidents involving high-pressure medical gas cylinders thathave resulted in death and injuries topatients. These amendments, togetherwith existing regulations, are intendedto ensure that the types of incidentsthat have occurred in the past, as wellas other types of foreseeable andpotentially deadly medical gas

accidents, do not occur in the future.

Timetable:

Action Date FR Cite

NPRM 04/10/06 71 FR 18039


07/10/06



Agency Contact: Patrick Raulerson,Regulatory Counsel, Department ofHealth and Human Services, Food andDrug Administration, Center for DrugEvaluation and Research, WO 51, Room6368, 10903 New Hampshire Avenue,Silver Spring, MD 209930002Phone: 301 7963522Fax: 301 8478440Email: [email protected]

RIN: 0910AC53

150. CONTENT AND FORMAT OFLABELING FOR HUMANPRESCRIPTION DRUGS ANDBIOLOGICS; REQUIREMENTS FORPREGNANCY AND LACTATION

LABELINGLegal Authority: 21 USC 321; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 358; 21 USC 360; 21 USC 360b;21 USC 360gg to 360ss; 21 USC 371;21 USC 374; 21 USC 379e; 42 USC 216;42 USC 241; 42 USC 262; 42 USC 264

Abstract: To amend the regulationsgoverning the format and content oflabeling for human prescription drugsand biological products (21 CFR parts201.56, 201.57, and 201.80). UnderFDAs current regulations, labelingconcerning the use of prescription

drugs in pregnancy uses lettercategories (A, B, C, D, X) to characterizethe risk to the fetus of using the drugin pregnancy. One of the deficienciesof the category system is that drugsmay be assigned to the same categorywhen the severity, incidence, and typesof risk are quite different.Dissatisfaction with the category systemhas been expressed by health careproviders, medical organizations,experts in the study of birth defects,womens health researchers, andwomen of childbearing age.Stakeholders consulted through apublic hearing, several focus groups,

and several advisory committees haverecommended that FDA replace thecategory system with a concisenarrative summarizing a products risksto pregnant women and to women ofchildbearing age. Therefore, the revisedformat and the information provided inthe labeling would make it easier forhealth care providers to understand therisks and benefits of drug use duringpregnancy and lactation.

Timetable:

Action Date FR Cite

NPRM 05/29/08 73 FR 30831


08/27/08



Agency Contact: Rachel S. Bressler,Regulatory Counsel, Department ofHealth and Human Services, Food andDrug Administration, Center for DrugEvaluation Research, WO 51, Room6224, 10903 New Hampshire Avenue,Silver Spring, MD 209930002Phone: 301 7964288


8/9/2019 2010-08934_PI

16/24


HHSFDA Final Rule Stage

Fax: 301 8478440Email: [email protected]

RIN: 0910AF11

151. INFANT FORMULA: CURRENTGOOD MANUFACTURINGPRACTICES; QUALITY CONTROLPROCEDURES; NOTIFICATIONREQUIREMENTS; RECORDS ANDREPORTS; AND QUALITY FACTORS

Legal Authority: 21 USC 321; 21 USC350a; 21 USC 371; .. .

Abstract: The Food and DrugAdministration (FDA) is revising itsinfant formula regulations in 21 CFRparts 106 and 107 to establishrequirements for current goodmanufacturing practices (CGMP),including audits; to establishrequirements for quality factors; and toamend FDAs quality controlprocedures, notification, and recordand reporting requirements for infantformula. FDA is taking this action toimprove the protection of infants whoconsume infant formula products.

Timetable:

Action Date FR Cite

NPRM 07/09/96 61 FR 36154

NPRM Comment

Period End

12/06/96


04/28/03 68 FR 22341

NPRM CommentPeriod Extended

06/27/03 68 FR 38247


08/26/03


08/01/06 71 FR 43392


09/15/06



Agency Contact: Benson Silverman,Department of Health and HumanServices, Food and DrugAdministration, Center for Food Safetyand Applied Nutrition (HFS850), 5100Paint Branch Parkway, College Park,MD 20740Phone: 301 4361459Email: [email protected]

RIN: 0910AF27

152. OVERTHECOUNTER (OTC)DRUG REVIEWCOUGH/COLD(BRONCHODILATOR) PRODUCTS

Legal Authority: 21 USC 321p; 21 USC

331; 21 USC 351 to 353; 21 USC 355;21 USC 360; 21 USC 371

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. This action addresseslabeling for single ingredient

bronchodilator products.

Timetable:

Action Date FR Cite

NPRM (AmendmentEphedrine SingleIngredient)

07/13/05 70 FR 40237


11/10/05


11/30/07 72 FR 67639

Final Action(AmendmentSingle IngredientLabeling)

09/00/10



RIN: 0910AF32

153. OVERTHECOUNTER (OTC)DRUG REVIEWCOUGH/COLD

(COMBINATION) PRODUCTSLegal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 360; 21 USC 371

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legally

marketed. This action addressescough/cold drug products containing anoral bronchodilator (ephedrine and itssalts) in combination with anyexpectorant or any oral nasal

decongestant.

Timetable:

Action Date FR Cite

NPRM (Amendment) 07/13/05 70 FR 40232


11/10/05


03/19/07 72 FR 12730




Department of Health and HumanServices, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF33

154. OVERTHECOUNTER (OTC)DRUG REVIEWEXTERNALANALGESIC PRODUCTS


Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The final action addressesthe 2003 proposed rule on patches,plasters, and poultices. The proposed

rule will address issues not addressedin previous rulemakings.

Timetable:

Action Date FR Cite

Final Action (GRASEdosage forms)

12/00/10

NPRM (Amendment) To Be Determined


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and Human


8/9/2019 2010-08934_PI

17/24



Services, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF35

155. OVERTHECOUNTER (OTC)DRUG REVIEWSKIN PROTECTANTPRODUCTS


Abstract: The OTC drug review

establishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The first action addressesskin protectant products used to treatfever blisters and cold sores. Thesecond action identifies safe andeffective skin protectant activeingredients to treat and prevent diaperrash.

Timetable:

Action Date FR Cite

Final Action(Aluminum Acetate)(TechnicalAmendment)

03/06/09 74 FR 9759

Final Action (DiaperRash)

03/00/11

Final Action (TechnicalAmendments)

02/01/08 73 FR 6014

Final Action (FeverBlisters/Cold Sores)

03/00/11



RIN: 0910AF42

156. USE OF MATERIALS DERIVEDFROM CATTLE IN HUMAN FOOD ANDCOSMETICS

Legal Authority: 21 USC 342; 21 USC

361; 21 USC 371

Abstract: On July 14, 2004, FDA issuedan interim final rule (IFR), effectiveimmediately, to prohibit the use ofcertain cattle material and to addressthe potential risk of bovine spongiformencephalopathy (BSE) in human food,including dietary supplements, andcosmetics. Prohibited cattle materialsunder the IFR include specified riskmaterials, small intestine of all cattle,material from nonambulatory disabledcattle, material from cattle notinspected and passed for humanconsumption, and mechanicallyseparated (MS) beef. Specified riskmaterials are the brain, skull, eyes,trigeminal ganglia, spinal cord,vertebral column (excluding thevertebrae of the tail, the transverseprocesses of the thoracic and lumbarvertebrae, and the wings of the sacrum),and dorsal root ganglia of cattle 30months and older; and the tonsils anddistal ileum of the small intestine ofall cattle. Prohibited cattle materials donot include tallow that contains nomore than 0.15 percent hexane-insoluble impurities and tallowderivatives. This action minimizes

human exposure to materials thatscientific studies have demonstrated arehighly likely to contain the BSE agentin cattle infected with the disease.Scientists believe that the humandisease variant Creutzfeldt-Jakobdisease (vCJD) is likely caused by theconsumption of products contaminatedwith the agent that causes BSE.

Timetable:

Action Date FR Cite


Interim Final RuleEffective

07/14/04


10/12/04

Interim Final Rule(Amendments)

09/07/05 70 FR 53063

Interim Final Rule(Amendments)Effective

10/07/05

Interim Final Rule(Amendments)Comment PeriodEnd

11/07/05

Interim Final Rule(Amendments)

04/17/08 73 FR 20785

Action Date FR Cite

Interim Final Rule(Amendments)Comment Period

End

07/16/08

Interim Final Rule(Amendments)Effective

07/16/08



Agency Contact: Amber McCoig,Consumer Safety Officer, Department ofHealth and Human Services, Food andDrug Administration, Center for FoodSafety and Applied Nutrition,(HFS316), 5100 Paint Branch Parkway,College Park, MD 20740Phone: 301 4362131


RIN: 0910AF47

157. LABEL REQUIREMENT FORFOOD THAT HAS BEEN REFUSEDADMISSION INTO THE UNITEDSTATES

Legal Authority: 15 USC 1453 to 1455;21 USC 321; 21 USC 342 and 343; 21USC 371; 21 USC 374; 21 USC 381;42 USC 216; 42 USC 264

Abstract: The final rule will requireowners or consignees to label imported

food that is refused entry into theUnited States. The label will read,UNITED STATES: REFUSED ENTRY.The proposal describes the labelscharacteristics (such as its size) andprocesses for verifying that the labelhas been affixed properly. We aretaking this action to prevent theintroduction of unsafe food into theUnited States, to facilitate theexamination of imported food, and toimplement section 308 of the PublicHealth Security and BioterrorismPreparedness and Response Act of 2002(the Bioterrorism Act) (Pub. L. 107-

188).Timetable:

Action Date FR Cite

NPRM 09/18/08 73 FR 54106


12/02/08



Agency Contact:John D. Reilly,Regulatory Counsel, Department ofHealth and Human Services, Food and


8/9/2019 2010-08934_PI

18/24



Drug Administration, Center for FoodSafety and Applied Nutrition, CPK 1,Room 1C015, (HFS024), 5100 Paint

Branch Parkway, College Park, MD20740Phone: 301 4361530


RIN: 0910AF61



158. CURRENT GOODMANUFACTURING PRACTICE INMANUFACTURING, PACKING,LABELING, OR HOLDINGOPERATIONS FOR DIETARYSUPPLEMENTS

Legal Authority: 21 USC 321; 21 USC342 and 343; 21 USC 348; 21 USC 371;21 USC 374; 21 USC 381; 21 USC 393;42 USC 264

Abstract: The Food and DrugAdministration published a final rulein the Federal Register of June 25, 2007(72 FR 34752), on current goodmanufacturing practice (CGMP)regulations for dietary supplements.FDA also published an Interim FinalRule in the same Federal Register (72FR 34959) that provided a procedurefor requesting an exemption from thefinal rule requirement that themanufacturer conduct at least oneappropriate test or examination toverify the identity of any componentthat is a dietary ingredient. This IFRallows for submission to, and review

by, FDA of an alternative to therequired 100 percent identity testing ofcomponents that are dietaryingredients, provided certain conditionsare met. This IFR also establishes arequirement for retention of recordsrelating to the FDAs response to anexemption request.

Timetable:

Action Date FR Cite

ANPRM 02/06/97 62 FR 5700


06/06/97

NPRM 03/13/03 68 FR 12157


08/11/03

Final Rule 06/25/07 72 FR 34752



10/24/07



Agency Contact: Linda Kahl, SeniorPolicy Analyst, Department of Healthand Human Services, Food and Drug

Administration, Center for Food Safetyand Applied Nutrition (HFS024), 5100Paint Branch Parkway, College Park,MD 20740Phone: 301 4362784Fax: 301 4362657Email: [email protected]

RIN: 0910AB88

159. OVERTHECOUNTER (OTC)

DRUG REVIEWCOUGH/COLD(NASAL DECONGESTANT)PRODUCTS


Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legally

marketed. This action addresses theingredient phenylpropanolamine.

Timetable:

Action Date FR Cite

NPRM (Amendment)(Sinusitis Claim)

08/02/04 69 FR 46119


11/01/04

NPRM (PhenylephrineBitartrate)

11/02/04 69 FR 63482


01/31/05

NPRM (Phenyl-propanolamine)

12/22/05 70 FR 75988


03/22/06

Final Action(Amendment)(Sinusitis Claim)

10/31/05 70 FR 58974

Final Action(PhenylephrineBitartrate)

08/01/06 71 FR 83358

Final Action (Phenyl-propanolamine)

To Be Determined



Department of Health and HumanServices, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF34

160. OVERTHECOUNTER (OTC)DRUG REVIEWLABELING OF DRUGPRODUCTS FOR OTC HUMAN USE

Legal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 358; 21 USC 360; 21 USC 371;21 UCS 374; 21 USC 379e

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTC

drugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. This action addresseslabeling for convenience (small) sizeOTC drug packages.

Timetable:

Action Date FR Cite

NPRM (ConvenienceSizes)

12/12/06 71 FR 74474


04/11/07



Required: YesAgency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and HumanServices, Food and DrugAdministration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF37


8/9/2019 2010-08934_PI

19/24


HHSFDA Long-Term Actions

161. OVERTHECOUNTER (OTC)DRUG REVIEWOPHTHALMICPRODUCTS

Legal Authority: 21 USC 321p; 21 USC

331; 21 USC 351 to 353; 21 USC 355;21 USC 360; 21 USC 371

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. This action finalizes themonograph for emergency first aideyewash drug products.

Timetable:

Action Date FR Cite

NPRM (Amendment)(Emergency FirstAid Eyewashes)

02/19/03 68 FR 7917

Final Action(Amendment)(Emergency FirstAid Eyewashes)

To Be Determined


Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and HumanServices, Food and Drug

Administration, Center for DrugEvaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF39

162. OVERTHECOUNTER (OTC)DRUG REVIEWORAL HEALTH CAREPRODUCTS

Legal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;

21 USC 360 to 360a; 21 USC 371 to371a

Abstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e., final rule) is issued, only OTCdrugs meeting the conditions of themonograph, or having an approved newdrug application, may be legallymarketed. The NPRM and final actionwill address oral health care products

used to reduce or prevent dental plaqueand gingivitis.

Timetable:

Action Date FR Cite

ANPRM (PlaqueGingivitis)

05/29/03 68 FR 32232


08/27/03

NPRM (PlaqueGingivitis)

To Be Determined



Agency Contact: Walter J. Ellenberg,Regulatory Project Management Officer,Department of Health and HumanServices, Food and DrugAdministration, Center for Drug

Evaluation and Research, WO22,Room 5488, 10903 New HampshireAvenue, Silver Spring, MD 20993Phone: 301 7962090Fax: 301 7969899Email: [email protected]

RIN: 0910AF40

163. OVERTHECOUNTER (OTC)DRUG REVIEWVAGINALCONTRACEPTIVE PRODUCTS

Legal Authority: 21 USC 321p; 21 USC331; 21 USC 351 to 353; 21 USC 355;21 USC 358; 21 USC 360; 21 USC 371;

21 USC 374; 21 USC 379eAbstract: The OTC drug reviewestablishes conditions under whichOTC drugs are considered generallyrecognized as safe and effective and notmisbranded. After a final monograph(i.e.,

2010-08934_pi

Documents