Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2943 

dietary interventions), we will include 

all studies that otherwise meet the 

selection criteria to allow us to make 

overarching comments about the status 

of the FI treatment-outcomes literature 

in the final report. 

Setting 

Any setting (community dwelling, 

long-term care, other). 

Dated: December 30, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00764 Filed 1–20–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Performance Measures for 

Community-Centered Healthy Marriage, 

Pathways to Responsible Fatherhood 

and Community-Centered Responsible 

Fatherhood Ex-Prisoner Reentry grant 

programs. 

OMB No.: 0970–0365—Reinstatement 

with changes of a previously approved 

collection. 

Description: The Office of Family 

Assistance (OFA), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), intends to request 

approval from the Office of Management 

and Budget (OMB) to renew OMB Form 

0970–0365 for the collection of 

performance measures from grantees for 

the Community-Centered Healthy 

Marriage, Pathways to Responsible 

Fatherhood and Community-Centered 

Responsible Fatherhood Ex-Prisoner 

Reentry discretionary grant programs. 

The performance measure data obtained 

from the grantees will be used by OFA 

to report on the overall performance of 

these grant programs. 

Data will be collected from all 60 

Community-Centered Healthy Marriage, 

54 Pathways to Responsible Fatherhood 

and 5 Community-Centered Responsible 

Fatherhood Ex-Prisoner Reentry 

grantees in the OFA programs. Grantees 

will report on program and participant 

outcomes in such areas as participants’ 

improvement in knowledge skills, 

attitudes, and behaviors related to 

healthy marriage and responsible 

fatherhood. Grantees will be asked to 

input data for selected outcomes for 

activities funded under the grants. 

Grantees will extract data from program 

records and will report the data twice 

yearly through an on-line data 

collection tool. Training and assistance 

will be provided to grantees to support 

this data collection process. 

Respondents: Office of Family 

Assistance Funded CommunityCentered Healthy Marriage, Pathways to 

Responsible Fatherhood and 

Community-Centered Responsible 

Fatherhood Ex-Prisoner Reentry 

Grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Performance measure reporting form (for private sector affected public) ...... 110 2 0.8 176 

Performance measure reporting form (for State, local, and tribal government 

affected public) ............................................................................................. 9 2 0.8 14 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 190 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–00809 Filed 1–20–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0500] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
2944 Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

FDA’s requirements on content and 

format of labeling for human 

prescription drug and biological 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 23, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products (OMB Control 

Number 0910–0572)—Extension 

FDA’s regulations governing the 

format and content of labeling for 

human prescription drug and biological 

products were revised in the Federal 

Register of January 24, 2006 (71 FR 

3922), to require that the labeling of new 

and recently approved products contain 

highlights of prescribing information, a 

table of contents for prescribing 

information, reordering of certain 

sections, minor content changes, and 

minimum graphical requirements. 

These revisions were intended to make 

it easier for health care practitioners to 

access, read, and use information in 

prescription drug labeling; to enhance 

the safe and effective use of prescription 

drug products; and to reduce the 

number of adverse reactions resulting 

from medication errors due to 

misunderstood or incorrectly applied 

drug information. 

Currently, § 201.56 (21 CFR 201.56) 

requires that prescription drug labeling 

contain certain information in the 

format specified in either § 201.57 (21 

CFR 201.57) or § 201.80 (21 CFR 

201.80), depending on when the drug 

was approved for marketing. Section 

201.56(a) sets forth general labeling 

requirements applicable to all 

prescription drugs. Section 201.56(b) 

specifies the categories of new and more 

recently approved prescription drugs 

subject to the revised content and 

format requirements in §§ 201.56(d) and 

201.57. Section 201.56(c) sets forth the 

schedule for implementing these revised 

content and format requirements. 

Section 201.56(e) specifies the sections 

and subsections, required and optional, 

for the labeling of older prescription 

drugs not subject to the revised format 

and content requirements. 

Section 201.57(a) requires that 

prescription drug labeling for new and 

more recently approved prescription 

drug products include ‘‘Highlights of 

Prescribing Information’’. Highlights 

provides a concise extract of the most 

important information required under 

§ 201.57(c) (the Full Prescribing 

Information (FPI)), as well as certain 

additional information important to 

prescribers. Section 201.57(b) requires a 

table of contents to prescribing 

information, entitled ‘‘Full Prescribing 

Information: Contents,’’ consisting of a 

list of each heading and subheading 

along with its identifying number to 

facilitate health care practitioners’ use 

of labeling information. Section 

201.57(c) specifies the contents of the 

FPI. Section 201.57(d) mandates the 

minimum specifications for the format 

of prescription drug labeling and 

establishes minimum requirements for 

key graphic elements such as bold type, 

bullet points, type size, and spacing. 

Older drugs not subject to the revised 

labeling content and format 

requirements in § 201.57 are subject to 

labeling requirements at § 201.80. 

Section 201.80(f)(2) requires that within 

1 year, any FDA-approved patient 

labeling be referenced in the 

‘‘Precautions’’ section of the labeling of 

older products and either accompany or 

be reprinted immediately following the 

labeling. 

Annual Burden for Prescription Drug 

Labeling Design, Testing, and 

Submitting to FDA for New Drug 

Applications (NDAs) and Biologics 

License Applications (BLAs) (§§ 201.56 

and 201.57). New drug product 

applicants must: (1) Design and create 

prescription drug labeling containing 

‘‘Highlights’’, ‘‘Contents’’, and FPI, (2) 

test the designed labeling (e.g., to ensure 

that the designed labeling fits into 

carton-enclosed products), and (3) 

submit it to FDA for approval. Based on 

the projected data used in the January 

24, 2006, final rule, FDA estimates that 

it takes applicants approximately 3,349 

hours to design, test, and submit 

prescription drug labeling to FDA as 

part of an NDA or a BLA under the 

revised regulations. Currently, 

approximately 131 applicants submit 

approximately 196 new applications 

(NDAs and BLAs) to FDA annually, 

totaling 656,404 hours. 

FDA estimates the burden of this 

collection of information as follows: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2945 

1There are no capital costs or operating and 

maintenance costs associated with this collection of 

information. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Part Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Labeling Requirements in §§ 201.56 and 201.57 ................ 131 1.5 196 3,349 656,404 

Dated: January 13, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00761 Filed 1–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

Advisory Committee on Training in 

Primary Care Medicine and Dentistry 

Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(92), notice is hereby given of the 

following meeting: 

Name: Advisory Committee on 

Training in Primary Care Medicine and 

Dentistry (ACTPCMD). 

Dates and Times: February 6, 2015 

(10:00 a.m.–4:00 p.m.) 

Place: Webinar and Conference Call 

Format. 

Status: The meeting will be open to 

the public. 

Purpose: The ACTPCMD provides 

advice and recommendations on a broad 

range of issues relating to grant 

programs authorized by sections 222 

and 749 of the Public Health Service 

Act, as amended by section 5103(d) and 

re-designated by section 5303 of the 

Patient Protection and Affordable Care 

Act of 2010. 

The ACTPCMD members will discuss 

health literacy and patient engagement 

for inclusion in the 12th ACTPCMD 

Report. The report will be submitted to 

the Secretary of the Department of 

Health and Human Services; the 

Committee on Health, Education, Labor, 

and Pensions of the Senate; and the 

Committee on Energy and Commerce of 

the House of Representatives. 

Agenda: The ACTPCMD agenda 

provides opportunity for members to 

discuss health literacy and patient 

engagement for inclusion in the 12th 

ACTPCMD Report. An official agenda 

will be available 2 days prior to the 

meeting on the HRSA Web site (http:// 

www.hrsa.gov/advisorycommittees/

bhpradvisory/actpcmd/index.html). 

Agenda items are subject to change as 

priorities dictate. 

Public Comment: Requests to make 

oral comments or provide written 

comments to the ACTPCMD should be 

sent to Dr. Joan Weiss, Designated 

Federal Official, using the address and 

phone number below. Individuals who 

plan to participate on the conference 

call or webinar should notify Dr. Weiss 

at least 3 days prior to the meeting, 

using the address and phone number 

below. Members of the public will have 

the opportunity to provide comments. 

Interested parties should refer to the 

meeting subject as the HRSA Advisory 

Committee on Training in Primary Care 

Medicine and Dentistry. 

The conference call-in number is 800– 

369–1867. The passcode is: 8803797. 

The webinar link is https://

hrsa.connectsolutions.com/actpcmd/. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requesting information 

regarding the ACTPCMD should contact 

Dr. Joan Weiss, Designated Federal 

Official within the Bureau of Health 

Workforce, Health Resources and 

Services Administration, in one of three 

ways: 1) Send a request to the following 

address: Dr. Joan Weiss, Designated 

Federal Official, Bureau of Health 

Workforce, Health Resources and 

Services Administration, Parklawn 

Building, Room 12C–05, 5600 Fishers 

Lane, Rockville, Maryland 20857; 2) call 

(301) 443–0430; or 3) send an email to 

jweiss@hrsa.gov. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2015–00841 Filed 1–20–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

Advisory Committee on 

Interdisciplinary, Community-Based 

Linkages; Notice of Meeting 

In accordance with section 10(a) (2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on 

Interdisciplinary, Community-Based 

Linkages (ACICBL). 

Dates And Times: January 28, 2015 

(10:00 a.m.–4:00 p.m.). 

Place: Webinar and Conference Call 

Format. 

Status: The meeting will be open to 

the public. 

Purpose: The members of the ACICBL 

will discuss the legislatively mandated 

15th Annual Report to the Secretary of 

Health and Human Services and 

Congress. The Committee members will 

discuss programmatic recommendations 

for each of the programs under Title VII 

Part D. 

The programs under Title VII Part D 

include: 750—General Provisions; 751— 

Area Health Education Centers; 752— 

Continuing Education Support for 

Health Professionals Serving in 

Underserved Communities; 753— 

Education and Training Related to 

Geriatrics; 754—Quentin N. Burdick 

Program for Rural Interdisciplinary 

Training; 755—Allied Health and Other 

Disciplines; 756—Mental and 

Behavioral Health Education and 

Training Grants; 757—Advisory 

Committee on Interdisciplinary, 

Community-Based Linkages; and 759— 

Program for Education and Training in 

Pain Care. The logistical challenges of 

scheduling this meeting hindered an 

earlier publication of this meeting 

notice. 

Agenda: The ACICBL agenda includes 

an opportunity for members to discuss 

the content of the 15th Annual Report 

and to listen to expert presentations to 

develop the report. The agenda will be 

available 2 days prior to the meeting on 

the Heath Resources and Services 

Administration (HRSA) Web site (http:// 

www.hrsa.gov/advisorycommittees/

bhpradvisory/acicbl/acicbl.html). 

Agenda items are subject to change as 

priorities dictate. 

Public Comment: Requests to make 

oral comments or provide written 

comments to the ACICBL should be sent 

to Dr. Joan Weiss, Designated Federal 

Official, using the address and phone 

number below. Individuals who plan to 

participate on the conference call or 

webinar should notify Dr. Weiss at least 

3 days prior to the meeting, using the 


asabaliauskas on DSK5VPTVN1PROD with NOTICES