68890 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Adult Screener ..................................................... 24,000 1 24,000 0.03 (2 minutes) ............ 720 

Study 1 (Adults) ................................................... 1,800 1 1,800 0.333 (20 minutes) ........ 599 

Study 2 (Adults) ................................................... 600 1 600 0.333 (20 minutes) ........ 200 

Total adult hours ........................................... ........................ ........................ ........................ ....................................... 1,519 

Youth Screener .................................................... 6,000 1 6,000 0.03 (2 minutes) ............ 180 

Study 3 (Youth) .................................................... 600 1 600 0.333 (20 minutes) ........ 200 

Total youth hours .......................................... ........................ ........................ ........................ ....................................... 380 

Total Hours ............................................ ........................ ........................ ........................ ....................................... 1,899 

FDA’s burden estimate is based on 

prior experience with research that is 

similar to this proposed study. 

Approximately 30,000 respondents will 

complete a screener to determine 

eligibility for participation in a study, 

estimated to take approximately 2 

minutes (0.03 hours), for a total of 900 

hours for screening activities. Three 

thousand respondents will complete a 

full study, estimated to last 20 minutes 

(0.333 hours), for a total of 999 hours for 

completion of both adult studies and 

one youth study. The estimated total 

hour burden of the collection of 

information is 1,899 hours. 

Dated: November 12, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27283 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1840] 

Electronic Study Data Submission; 

Data Standards; Validation Rules for 

Study Data Tabulation Model 

Formatted Studies; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Center for Drug 

Evaluation and Research (CDER) is 

announcing the availability of a 

document entitled ‘‘Validation Rules for 

Study Data Tabulation Model (SDTM) 

Formatted Studies.’’ CDER is making 

this document available to improve the 

standardization and quality of clinical 

data submitted to CDER, as well as to 

improve the predictability of data 

quality and usefulness. 

FOR FURTHER INFORMATION CONTACT: 

Office of Strategic Programs, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1192, 

Silver Spring, MD 20993, email: edata@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: CDER 

supports the regulatory submission of 

standardized clinical study data based 

on the Clinical Data Interchange 

Standards Consortium SDTM. Upon 

receipt of the data, CDER validates the 

data using a set of validation rules. The 

‘‘Validation Rules for SDTM Formatted 

Studies’’ is an Excel file that provides a 

human readable description of a rule set 

for validation. Submitters of clinical 

study data can use this information to 

understand how FDA validates the data. 

The file is available on FDA’s Study 

Data Standards Resources Web page at 

http://www.fda.gov/ForIndustry/

DataStandards/StudyDataStandards/

default.htm. It contains a combination 

of conformance rules (i.e., how well the 

data conform to the standard) and 

business rules (i.e., quality checks; how 

well the data may support useful 

analysis). The rules may be updated 

periodically as new or updated 

validation rules are developed. The 

Change History tab will provide a 

descriptive change history of the 

document. 

Dated: November 14, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27384 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–1120] 

Vaginal Microbicides: Development for 

the Prevention of Human 

Immunodeficiency Virus Infection; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Vaginal Microbicides: 

Development for the Prevention of HIV 

Infection.’’ The purpose of this guidance 

is to assist sponsors in all phases of 

development of vaginal microbicides, 

defined as vaginal drug products that 

prevent human immunodeficiency virus 

(HIV) acquisition. The guidance outlines 

the types of nonclinical studies and 

clinical trials recommended throughout 

the drug development process to 

support approval of vaginal 

microbicides. This guidance finalizes 

the draft guidance issued on November 

23, 2012. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 68891 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Charu Mullick, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6365, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Vaginal Microbicides: Development for 

the Prevention of HIV Infection.’’ This 

guidance addresses nonclinical 

development, early phases of clinical 

development, phase 3 trial 

considerations, and safety 

considerations in vaginal microbicide 

development including safety 

considerations in adolescent and 

pregnant populations. The guidance 

also outlines development of 

combination microbicide products such 

as drug-drug combinations, drug-device 

combinations, or combination products 

that include microbicide and are 

intended for multiple indications. This 

guidance finalizes the draft guidance 

issued on November 23, 2012 (77 FR 

70167). The majority of public 

comments submitted to the docket were 

related to clinical trial considerations 

and nonclinical pharmacology/

toxicology issues. This guidance 

incorporates FDA responses to the 

public comments. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on developing vaginal 

microbicides for preventing HIV 

transmission. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 312 have 

been approved under 0910–0014, and 

the collections of information referred to 

in the guidance for clinical trial 

sponsors entitled ‘‘Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees’’ have been 

approved under 0910–0581. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 13, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27287 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1741] 

Proposed Criteria for ‘‘First Generic’’ 

Submissions for Purposes of 

Abbreviated New Drug Application 

Review Prioritization Under the 

Generic Drug User Fee Amendments; 

Establishment of a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of public 

docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the opening of a public 

docket and requesting comments on 

proposed criteria for ‘‘first generic’’ 

abbreviated new drug application 

(ANDA) submissions. The purpose is to 

facilitate FDA’s establishment of review 

prioritization under the Generic Drug 

User Fee Amendments of 2012 

(GDUFA). Establishing clear criteria for 

this review prioritization category will 

allow FDA to appropriately prioritize 

ANDA submissions and track them in a 

manner consistent with the review 

prioritization commitments FDA made 

under GDUFA. Clear criteria for this 

category will also lead to less industry 

confusion and more consistent 

identification of ‘‘first generic’’ 

submissions. 

DATES: Submit either electronic or 

written comments by December 19, 

2014. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments as 

follows: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments as follows: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions must 

include the Docket No. found in 

brackets in the heading of this 

document. All comments received may 

be posted without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts or 

go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Maryll Toufanian, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1682, 

Silver Spring, MD 20993–0002, 240– 

402–7944. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, GDUFA (Title III of 

the Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

144)) was signed into law by the 

President. GDUFA is designed to speed 

the delivery of safe and effective generic 

drugs to the public and to reduce costs 

to industry. GDUFA is based on an 

agreement negotiated by FDA and 

representatives of the generic drug 

industry to address a growing number of 

regulatory challenges. An attendant 

mstockstill on DSK4VPTVN1PROD with NOTICES