31448 Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices 

Respondents: 50 States and 9 

Territories, to include, District of 

Columbia, Puerto Rico, Virgin Islands, 

Guam, American Samoa, Northern 

Mariana Islands, the Federated States of 

Micronesia, the Marshall Islands and 

Palau 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Application to include program narrative ......................................................... 59 1 40 2360 

Performance Progress Reports ....................................................................... 59 2 10 1180 

Year 1 Implementation Plan ............................................................................ 59 1 30 1770 

Performance Measure Reporting .................................................................... 59 1 10 590 

Estimated Total Annual Burden 

Hours: 5900. 

Additional Information: 

The Year 1 Implementation Plan is 

only required to be completed and 

submitted in the first year of the project 

period. This is a one time submission 

and will not occur annually. 

The potential awardees could include 

organizations and other entities 

awarded in year 3 of the project period 

in States that did not apply for funding 

in the first 2 years of the project period. 

A copy of this information collection, 

with applicable supporting 

documentation, may be obtained by 

calling the Administration for Children 

and Families, Reports Clearance Officer, 

Robert Sargis at (202) 690–7275. 

Interested persons are invited to submit 

comments regarding this request. 

Comments must be received within 

thirty days from the publication date of 

this Notice. 

Comments about the information 

collection described above should be 

directed to the Office of Information and 

Regulatory Affairs, Attn: OMB Desk 

Officer for ACF, Office of Management 

and Budget, Paperwork Reduction 

Project, 725 17th Street NW., 

Washington, DC 20503; FAX: (202) 395– 

7285; e-mail: 

oira_submission@omb.eop.gov. 

Dated: May 25, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–13106 Filed 6–2–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0248] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Format and 

Content Requirements for Over-theCounter Drug Product Labeling 

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 

information, including each proposed 

reinstatement 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 standardized format and content 

requirements for the labeling of overthe-counter (OTC) drug products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 2, 2010. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.berbakos@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 reinstatement 

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. 

Format and Content Requirements for 

OTC Drug Product Labeling (OMB 

Control Number 0910 0340)— 

Reinstatement 

In the Federal Register of March 17, 

1999 (64 FR 13254), we amended our 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices 31449 

regulations governing requirements for 

human drug products to establish 

standardized format and content 

requirements for the labeling of all 

marketed OTC drug products in part 201 

(21 CFR part 201) (the 1999 labeling 

final rule). The regulations in part 201 

require OTC drug product labeling to 

include uniform headings and 

subheadings, presented in a 

standardized order, with minimum 

standards for type size and other 

graphical features. Specifically, the 1999 

labeling final rule added new § 201.66 

to part 201. Section 201.66 sets content 

and format requirements for the Drug 

Facts portion of labels on OTC drug 

products. 

The only burden to comply with the 

regulations in part 201 is a one-time 

burden for OTC sunscreen products and 

new OTC drug products introduced to 

the marketplace under new drug 

applications (NDAs) or abbreviated new 

drug applications (ANDAs). All OTC 

drug products except sunscreens and 

new OTC products marketed under 

NDAs or ANDAs are already required to 

be in compliance with these labeling 

regulations. On June 20, 2000 (65 FR 

38191), we published a Federal Register 

document that required all OTC drug 

products marketed under the OTC 

monograph system except sunscreen 

products to comply with the regulations 

by May 16, 2005, or sooner (65 FR 

38191 at 38193). Sunscreen products do 

not have to comply with the regulations 

until we lift the stay of the sunscreen 

final rule that was published in the 

Federal Register on May 21, 1999 (64 

FR 27666) (the 1999 sunscreen final 

rule). In the Federal Register of 

December 31, 2001 (66 FR 67485), we 

stayed the 1999 sunscreen final rule 

indefinitely. In the Federal Register of 

September 3, 2004 (69 FR 53801), we 

delayed the § 201.66 implementation 

date for OTC sunscreen products 

indefinitely. Because the compliance 

date has passed for all OTC drug 

products except sunscreens and drug 

products introduced under new NDAs 

or ANDAs, we believe that the labeling 

burden associated with the 1999 

labeling final rule applies only to these 

products. We do not anticipate receiving 

any requests for exemptions or deferrals 

under § 201.66(e) because we have only 

received one request in the past 8 years. 

We estimate that there are 4,750 OTC 

sunscreen drug product stock keeping 

units (SKUs) that have not yet complied 

with the 1999 labeling final rule. All of 

these SKUs will need to implement the 

new labeling format by the 

implementation date included in the 

1999 sunscreen final rule when it is 

published in the Federal Register. We 

estimate that these 4,750 SKUs are 

marketed by 400 manufacturers and that 

approximately 2 hours will be spent on 

each submission (see table 1 of this 

document). The number of hours per 

submission (response) is based on our 

estimate in the 1999 labeling final rule 

(64 FR 13254 at 13276). If an average of 

2 hours is spent preparing, completing, 

and reviewing each of the estimated 

4,750 sunscreen SKUs, the total number 

of hours dedicated to the labeling of 

sunscreen products would be 9,500 

hours (4,750 SKUs times 2 hours/SKU) 

(see table 1 of this document). 

Based on estimates provided by the 

Consumer Healthcare Products 

Association, we believe that 

approximately 500 new OTC drug 

product SKUs marketed under NDAs or 

ANDAs are introduced to the 

marketplace each year. We estimate that 

these SKUs are marketed by 300 

manufacturers. We estimate that the 

preparation of labeling for new NDAs 

and ANDAs will require 5 hours to 

prepare, complete, and review new 

labeling prior to submitting the new 

labeling to us. Based on this estimate, 

the annual reporting burden for this 

type of labeling is approximately 2,500 

hours (see table 1 of this document). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

201.66(c) and (d)2 400 11 .88 4,750 2 9,500 

201.66(c) and (d)3 300 1 .67 500 5 2,500 

Total 12,000 

1FDA estimates that capital costs of 22 to 25 million dollars will result from preparing labeling content and format in accordance with § 201.66. 

There are no operating or maintenance costs associated with this collection of information. 2Burden for manufacturers of sunscreen drug product. 

3Burden for manufacturers of products marketed under new NDAs or ANDAs. 

Dated: May 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13279 Filed 6–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality; Notice of Meeting 

In accordance with section 10(d) of the 

Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel 

(SEP) meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

research who are invited by the Agency 

for Healthcare Research and Quality 

(AHRQ), and agree to be available, to 

conduct on an as needed basis, 

scientific reviews of applications for 

AHRQ support. Individual members of 

the Panel do not attend regularlyscheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

Substantial segments of the upcoming 

SEP meeting listed below will be closed 

to the public in accordance with the 

Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications for the AHRQ Limited 

Competition: PROSPECT STUDIES— 

Building New Clinical Infrastructure for 

CE (R01) applications are to be reviewed 


sroberts on DSKD5P82C1PROD with NOTICES