71858 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Notices 

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 particpate 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 Building Research 

Infrastructure Capacity’’ (BRIC) RFA, 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: The Building Research 

Infrastructure Capacity (BRIC) RFA. 

Date: December 15–16, 2005 (Open on 

December 15 from 8 a.m. to 8:15 a.m. and 

closed for the remainder of the meeting). 

Place: Doubletree Hotel, Executive Meeting 

Center, Rockville, Maryland 20850. 

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: November 21, 2005. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 05–23491 Filed 11–29–05; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004G–0381] 

Guidance for Industry and Food and 

Drug Administration Staff, Guidance 

for Records Access Authority Provided 

in Title III, Subtitle A, of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 

2002; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of Guidance for Industry 

and FDA Staff entitled ‘‘Guidance for 

Records Access Authority Provided in 

Title III, Subtitle A, of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ The 

document finalizes the draft guidance 

entitled ‘‘Draft Guidance for Records 

Access Authority Provided in Title III, 

Subtitle A, of the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002.’’ The guidance 

clarifies the circumstances under which 

FDA may access and copy records under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002. (‘‘Bioterrorism 

Act’’), and describes the procedure that 

FDA intends to follow to exercise its 

authority to inspect records under the 

Federal Food, Drug, and Cosmetic Act 

(the act). 

DATES: Submit written or electronic 

comments on agency guidance 

documents at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Guidance for Records Access Authority 

Provided in Title III, Subtitle A, of the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 

2002’’ to the Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857. Send two self-addressed 

adhesive labels to assist that office in 

processing your request, or fax your 

request to 240–632–6861. Submit 

written comments on the final guidance 

to the Division of Dockets Management 

(HFA–305), 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Diane Kelley, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–632–6860, or 

e-mail Diane.Kelley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 9, 

2004 (69 FR 71657), FDA (we) 

announced the availability of a draft 

guidance entitled ‘‘Draft Guidance for 

Records Access Authority Provided in 

Title III, Subtitle A, of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ FDA has 

finalized the guidance. 

FDA received a number of comments 

in response to the draft guidance. The 

agency considered those within the 

scope of this document carefully and is 

making two changes to the draft 

guidance. First, we have expanded the 

answer to question III.C, which 

describes records FDA may not access, 

to clarify that FDA has authority to 

access lists of ingredients (sections 

414(a) and 704(a) of the act. Second, we 

have changed the answer to question III. 

E, which describes how FDA intends to 

make a records request, to indicate that 

FDA intends to use a new form to make 

such a request. FDA has decided to 

create a specific form to document a 

request to access and copy records 

under the Bioterrorism Act. The form 

FDA 482c ‘‘Notice of Inspection—

Request for Records’’ will be presented 

to the owner, operator, or agent in 

charge, once FDA determines that the 

threshold for requesting records has 

been attained. This form will assist 

industry and the agency in 

distinguishing this type of notice from 

a routine Notice of Inspection. 

This Level 1 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 how it will exercise 

its authority to access records under the 

Bioterrorism Act (sections 414(a) and 

704(a) of the act (21 U.S.C. 350c and 

374)). 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 statute, 

regulations, or both. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork