22560 Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices 

EXHIBIT 3—ESTIMATED COST

Cost component Total cost Annualized 

cost 

Review of literature .................................................................................................................................................. $20,000 $13,334 

Cognitive interviews ................................................................................................................................................. 60,000 40,000 

Field test .................................................................................................................................................................. 90,000 60,000 

Data analyses .......................................................................................................................................................... 40,000 26,667 

Finalize survey ......................................................................................................................................................... 35,000 23,334 

AHRQ project management .................................................................................................................................... 50,000 33,334 

Total .................................................................................................................................................................. 295,000 196,669 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: May 4, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–11012 Filed 5–12–09; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–D–0122] (formerly 

Docket No. 2004D–0327) 

Compliance Guidance for Small 

Business Entities on Labeling Overthe-Counter Human Drug Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a compliance guidance 

for small business entities entitled 

‘‘Labeling OTC Human Drug Products; 

Small Entity Compliance Guide.’’ FDA 

has prepared this guidance in 

accordance with the Small Business 

Regulatory Enforcement Fairness Act. It 

is intended to help small businesses 

better understand and comply with the 

agency’s over-the-counter (OTC) 

labeling requirements and to prepare 

new labeling. This compliance guidance 

finalizes the draft compliance guidance 

published on December 9, 2004. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this compliance 

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 selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

compliance guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the compliance 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Marina Y. Chang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5418, 

Silver Spring, MD 20993–0002, 301– 

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a compliance guidance for small 

business entities entitled ‘‘Labeling OTC 

Human Drug Products; Small Entity 

Compliance Guide.’’ FDA has prepared 

this guidance in accordance with 

section 212 of the Small Business 

Regulatory Enforcement Fairness Act. 

This is one of several guidances the 

agency has developed to help 

manufacturers, packers, and distributors 

implement the final rule establishing 

standardized content and format 

requirements for the labeling of all OTC 

drug products. Once finalized, these 

guidances supersede all other 

statements, feedback, and 

correspondence provided by the agency 

on these matters since the issuance of 

the final rule. 

In the Federal Register of March 17, 

1999 (64 FR 13254), FDA published a 

final rule establishing standardized 

content and format requirements for the 

labeling of OTC drug products (21 CFR 

201.66). This regulation is intended to 

standardize labeling for all OTC drug 

products so consumers can easily read 

and understand OTC drug product 

labeling and use these products safely 

and effectively. The regulation requires 

manufacturers to present OTC drug 

labeling information in a prescribed 

order and format. The standardized 

format requires revision of all existing 

labeling and covers all OTC drug and 

drug-cosmetic products, whether 

marketed under a new drug application, 

abbreviated new drug application, or 

OTC drug monograph (or drug product 

not yet the subject of a final OTC drug 

monograph). 

Following issuance of the final rule, 

the agency received a number of 

inquiries from manufacturers seeking 

guidance on how to present the labeling 

information for their OTC drug products 

using the standardized content and 

format requirements. To address these 

inquiries, FDA published a notice in the 

Federal Register of December 9, 2004 

(69 FR 71420), announcing the 

availability of a draft compliance 

guidance for small business entities 

entitled ‘‘Labeling OTC Human Drug 

Products; Small Entity Compliance 

Guide.’’ The draft compliance guidance 

summarizes the new Drug Facts labeling 

requirements set forth in § 201.66. The 

Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices 22561 

draft compliance guidance also 

describes how to list those inactive 

ingredients that are different when a 

finished OTC drug product is obtained 

from multiple suppliers. 

The notice invited interested persons 

to submit comments on the draft 

compliance guidance by February 7, 

2005. FDA did not receive any 

comments in response to the notice, and 

is announcing the availability of this 

final compliance guidance with only 

editorial revisions to the draft guidance. 

This compliance guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The compliance guidance 

represents the agency’s current thinking 

on how OTC drug product labeling can 

be converted to the new OTC Drug Facts 

format labeling. 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. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

May 4, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–11089 Filed 5–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Fogarty 

International Center Advisory Board. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Fogarty International 

Center Advisory Board. 

Date: May 18–19, 2009. 

Closed: May 18, 2009, 1:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Lawton Chiles International House, Bethesda, 

MD 20892. 

Open: May 19, 2009, 8:30 a.m. to 4 p.m. 

Agenda: Discussions will focus on FIC 

activities and plans. Topics to be discussed: 

The pros/cons of creating an FIC centers-type 

grant; Priorities in distance learning 

applications and public health informatics; 

and future directions for the FIC framework 

program. 

Place: National Institutes of Health, 

Lawton Chiles International House, Bethesda, 

MD 20892. 

Contact Person: Robert Eiss, Public Health 

Advisor, Fogarty International Center, 

National Institutes of Health, 31 Center Drive, 

Room B2C02, Bethesda, MD 20892, (301) 

496–1415, EISSR@MAIL.NIH.GOV. 

This meeting is being published less than 

15 days prior to the meeting due to timing 

limitations imposed by administrative 

matters. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, drivers license, 

or passport) and to state the purpose of their 

visit. Information is also available on the 

Institutes/Centers home page: http:// 

www.nih.gov/fic/aboutladvisory.html, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.106, Minority International 

Research Training Grant in the Biomedical 

and Behavioral Sciences; 93.154, Special 

International Postdoctoral Research Program 

in Acquired Immunodeficiency Syndrome; 

93.168, International Cooperative 

Biodiversity Groups Program; 93.934, Fogarty 

International Research Collaboration Award; 

93.989, Senior International Fellowship 

Awards Program, National Institutes of 

Health, HHS) 

Dated: May 5, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–11002 Filed 5–12–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Library of 

Medicine Special Emphasis Panel; 

Competitive Revision. 

Date: June 12, 2009. 

Time: 9 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Library of Medicine, 

Building 38, Board Room, 2nd Floor, 8600 

Rockville Pike, Bethesda, MD 20892. 

Contact Person: Arthur A. Petrosian, 

Scientific Review Administrator, Division of 

Extramural Programs, National Library of 

Medicine, 6705 Rockledge Drive, Suite 301, 

Bethesda, MD 20892–7968, 301–496–4253, 

petrosia@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.701, ARRA Related 

Biomedical Research and Research Support 

Awards, National Institutes of Health, HHS)