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
31450 Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices 

and discussed at this meeting. These 

discussions are likely to reveal personal 

information concerning individuals 

associated with the applications. This 

information is exempt from mandatory 

disclosure under the above-cited 

statutes. 

SEP Meeting on: AHRQ Limited 

Competition: PROSPECT STUDIES— 

Building New Clinical Infrastructure for 

CE (R01). 

Date: June 16, 2010 (Open on June 16 

from 8 a.m. to 8:15 a.m. and closed for 

the remainder of the meeting). 

Place: Hyatt Regency Bethesda Hotel, 

7400 Wisconsin Avenue, 1 Bethesda 

Metro Center, Bethesda, Maryland 

20814. 

Contact Person: Anyone wishing to 

obtain a roster of members, agenda or 

minutes of the non-confidential portions 

of this meeting should contact Mrs. 

Bonnie Campbell, Committee 

Management Officer, Office of 

Extramural Research, Education and 

Priority Populations, AHRQ, 540 

Gaither Road, Room 2038, Rockville, 

Maryland 20850, Telephone (301) 427– 

1554. 

Agenda items for this meeting are 

subject to change as priorities dictate. 

Dated: May 24, 2010. 

Carol M. Clancy, 

Director. 

[FR Doc. 2010–13109 Filed 6–2–10; 8:45 am] 

BILLING CODE 4160–90–M 

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 OS ARRA: 

Optimizing Prevention and Healthcare 

Management for Complex Patients (R21) 

applications are to be reviewed and 

discussed at this meeting. These 

discussions are likely to reveal personal 

information concerning individuals 

associated with the applications. This 

information is exempt from mandatory 

disclosure under the above-cited 

statutes. 

SEP Meeting on: OS ARRA: 

Optimizing Prevention and Healthcare 

Management for Complex Patients 

(R21). 

Date: June 24, 2010 (Open on June 24 

from 8 a.m. to 8:15 a.m. and closed for 

the remainder of the meeting). 

Place: Hilton Rockville Executive 

Meeting Center, 1750 Rockville Pike, 

Conference Room TBD, Rockville, MD 

20850. 

Contact Person: Anyone wishing to 

obtain a roster of members, agenda or 

minutes of the nonconfidential portions 

of this meeting should contact Mrs. 

Bonnie Campbell, Committee 

Management Officer, Office of 

Extramural Research, Education and 

Priority Populations, AHRQ, 540 

Gaither Road, Room 2038, Rockville, 

Maryland 20850, Telephone (301) 427– 

1554. 

Agenda items for this meeting are 

subject to change as priorities dictate. 

Dated: May 24, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–13108 Filed 6–2–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0004] 

[FDA 225–09–0014] 

Memorandum of Understanding by and 

Between the United States Food and 

Drug Administration and the 

International Anesthesia Research 

Society for the Safety of Key Inhaled 

and Intravenous Drugs in Pediatrics 

Public-Private Partnership 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the International Anesthesia Research 

Society (IARS). The purpose of this 

MOU is to establish a framework for 

collaboration between FDA and IARS 

and to support their shared interest of 

promoting the safe use of anesthetics 

and sedatives in children. 

DATES: The agreement became effective 

March 21, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Wendy R. Sanhai, Senior Scientific 

Advisor, Office of the Commissioner, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

4128, Silver Spring, MD 20993, 301– 

796–8518. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: May 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


sroberts on DSKD5P82C1PROD with NOTICES