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, 71858-71859 [05-23504]

Download as PDF 71858 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Food and Drug Administration Notice of Meeting 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 [Docket No. 2004G–0381] 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 VerDate Aug<31>2005 19:12 Nov 29, 2005 Jkt 208001 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. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 E:\FR\FM\30NON1.SGM 30NON1 Federal Register / Vol. 70, No. 229 / Wednesday, November 30, 2005 / Notices Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 1.337, 1.345, and 1.352 have been approved under OMB Control Number 0910–0560. III. 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. The final guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the final guidance at http:// www.fda.gov/oc/bioterrorism/ bioact.html under ‘‘Section 306 (Records Maintenance)’’. Dated: November 18, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–23504 Filed 11–29–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Multistate Conservation Grant Program; Priority List for Conservation Projects Fish and Wildlife Service, Department of the Interior. ACTION: Notice of receipt of priority list. AGENCY: SUMMARY: The U.S. Fish and Wildlife Service (FWS) is publishing in the Federal Register the priority list of wildlife and sport fish conservation projects submitted by the International VerDate Aug<31>2005 19:12 Nov 29, 2005 Jkt 208001 Association of Fish and Wildlife Agencies (IAFWA) for funding under the Multistate Conservation Grant Program. This notice is required by the Wildlife and Sport Fish Restoration Programs Improvement Act of 2000 (Pub. L. 106–408). FY 2006 grants may be awarded from this priority list. FOR FURTHER INFORMATION CONTACT: Pam Matthes, Multistate Conservation Grants Program Coordinator, Division of Federal Assistance, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Mail Stop MBSP–4020, Arlington, Virginia 22203; phone (703) 358–2156; or e-mail Pam_Matthes@fws.gov. The Wildlife and Sport Fish Restoration Programs Improvement Act of 2000 (Improvement Act) amended the Pittman-Robertson Wildlife Restoration Act (16 U.S.C. 669 et seq.) and the Dingell-Johnson Sport Fish Restoration Act (16 U.S.C. 777 et seq.) and established the Multistate Conservation Grant Program. The Improvement Act authorizes grants of up to $3 million annually from funds available under each of the Restoration Acts, for a total of up to $6 million annually. Grants may be awarded from a list of priority projects recommended to the FWS by the IAFWA. The Director of the FWS, exercising the authority of the Secretary of the Interior, need not fund all IAFWA-recommended projects, but may fund only those projects identified on IAFWA’s priority list. Funds under the Multistate Conservation Grant Program may be used for sport fisheries and wildlife management and research projects, boating access development, hunter safety and education, aquatic education, fish and wildlife habitat improvements and other purposes consistent with the purposes of the enabling legislation. To be eligible for funding, a project must benefit fish and/or wildlife conservation in at least 26 States, a majority of the States in a region of the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 71859 FWS, or a regional association of State fish and wildlife agencies. Grants may be awarded to a State or group of States as well as to non-governmental organizations. For the purpose of carrying out the National Survey of Fishing, Hunting and WildlifeAssociated Recreation, grants may be awarded to the FWS or to a State or a group of States. Also, IAFWA requires all project proposals to address its National Conservation Needs, which are announced annually by the IAFWA at the same time as its request for proposals. Further, applicants must provide certification that no activities conducted under a Multistate Conservation Grant will promote or encourage opposition to the regulated hunting or trapping of wildlife or to the regulated angling for or taking of fish. Eligible project proposals are reviewed and ranked by IAFWA Committees and interested nongovernmental organizations that represent conservation organizations, sportsmen organizations, and industries that support or promote fishing, hunting, trapping, recreational shooting, bow hunting, or archery. A final list of priority projects is recommended by the IAFWA’s Committee on National Grants to the Directors of State fish and wildlife agencies for their approval by majority vote. The final approved list is then recommended to the FWS for funding under the Multistate Conservation Grant Program and must be submitted to the FWS by October 1. This year, the FWS received a list of 23 IAFWA-recommended projects, 4 of which are recommended as contingent projects. They are recommended for funding in 2006, contingent on the Multistate Conservation Grant Program receiving additional funds as specified in the Safe, Accountable, Flexible, and Efficient Transportation Equity Act of 2005 (Pub. L. 109–059) passed in August 2005. The list recommended by IAFWA follows: BILLING CODE 4310–55–P E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 70, Number 229 (Wednesday, November 30, 2005)]
[Notices]
[Pages 71858-71859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23504]


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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

[[Page 71859]]

Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in 21 CFR 1.337, 1.345, and 1.352 have been approved under 
OMB Control Number 0910-0560.

III. 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. The final guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the final guidance 
at http://www.fda.gov/oc/bioterrorism/bioact.html under ``Section 306 
(Records Maintenance)''.

    Dated: November 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23504 Filed 11-29-05; 8:45 am]
BILLING CODE 4160-01-S