Notice: Guidance For Industry Fish and Fisheries Products Hazards and Controls: National Institutes of Health

Federal Register / Vol. 73, No.
25 / Wednesday, February 6, 2008 / Notices 6973
to CMS. The burden associated with this requests for single copies of the operate to bind FDA or the public. An
requirement is currently approved guidance to the Office of Food Safety alternative approach may be used if
under OMB control number 0938–0880 (HFS–317), Center for Food Safety and such approach satisfies the
with an expiration date of November 20, Applied Nutrition, 5100 Paint Branch requirements of the applicable statutes
2010. Pkwy., College Park, MD 20740. Send and regulations. This guidance modifies
Authority: Section 410A of the Medicare one self-addressed adhesive label to our previous guidance on this subject
Prescription Drug, Improvement, and assist the office in processing your (See ‘‘Fish and Fisheries Products
Modernization Act of 2003, Pub. L. No. 108– request, or fax your request to 301–436– Hazards and Controls Guidance, Third
173. (Catalog of Federal Domestic Assistance 2651. See the SUPPLEMENTARY Edition June 2001’’ http://
Program No. 93.773 Medicare—Hospital INFORMATION section for electronic www.cfsan.fda.gov/guidance.html). The
Insurance Program; and No. 93.774, access to the guidance document. recommendations in this guidance only
Medicare—Supplementary Medical
Insurance Program). FOR FURTHER INFORMATION CONTACT: pertain to grouper, amberjack, and
Byron Truglio, Center for Food Safety related predatory reef species associated
Dated: January 11, 2008. with CFP that have been captured in the
and Applied Nutrition (HFS–325), Food
Kerry Weems, Northern Gulf of Mexico. This guidance
and Drug Administration, 5100 Paint
Acting Administrator, Centers for Medicare Branch Pkwy., College Park, MD 20740, does not pertain to other species of fish
& Medicaid Services. that have not been associated with CFP.
301–436–1420.
[FR Doc. 08–511 Filed 2–1–08; 10:00 am]
SUPPLEMENTARY INFORMATION: II. Comments
BILLING CODE 4120–01–P
I. Background Interested persons may submit to the
FDA is announcing the availability of Division of Dockets Management (see
DEPARTMENT OF HEALTH AND ADDRESSES) written or electronic
a guidance document entitled ‘‘Fish and
HUMAN SERVICES comments regarding this guidance.
Fisheries Products Hazards and Controls
Guidance, Third Edition June 2001: Submit a single copy of electronic
Food and Drug Administration comments or two paper copies of any
Letter to Seafood Processors that
[Docket No. FDA–2008–D–0079] Purchase Grouper, Amberjack and mailed comments, except that
Related Predatory Reef Species individuals may submit one paper copy.
Guidance for Industry: Fish and Comments are to be identified with the
Captured in the Northern Gulf of
Fisheries Products Hazards and docket number found in brackets in the
Mexico.’’ The purpose of the document
Controls Guidance Third Edition June heading of this document. The guidance
is to revise guidance provided to
2001: Letter to Seafood Processors and received comments may be seen in
industry for processing potentially
that Purchase Grouper, Amberjack, the Division of Dockets Management
ciguatoxic fish species captured in the
and Related Predatory Reef Species between 9 a.m. and 4 p.m., Monday
northern Gulf of Mexico which are
Captured in the Northern Gulf of through Friday.
subject to the provisions of the Hazard
Mexico Please note that on January 15, 2008,
Analysis and Critical Control Point
the FDA Web site transitioned to the
AGENCY: Food and Drug Administration, regulation for seafood (21 CFR part 123)
Federal Dockets Management System
HHS. (the seafood HACCP regulation). This
(FDMS). FDMS is a Government-wide,
ACTION: Notice. guidance is in response to recent CFP
electronic docket management system.
outbreaks that have been traced to fish
SUMMARY: The Food and Drug Electronic submissions will be accepted
captured in an area in the United States
Administration (FDA) is announcing the by FDA through FDMS only.
where ciguatera was previously
availability of a guidance document extremely rare. CFP is caused by III. Electronic Access
entitled ‘‘Fish and Fisheries Products consumption of fish that have eaten
Hazards and Controls Guidance, Third Persons with access to the Internet
toxic marine algae directly or that have may obtain the guidance document at
Edition June 2001: Letter to Seafood eaten other toxin-contaminated fish.
Processors that Purchase Grouper, http://www.cfsan.fda.gov/
CFP can result in gastrointestinal, guidance.html.
Amberjack and Related Predatory Reef cardiovascular, and neurological
Species Captured in the Northern Gulf symptoms. In severe cases, recurring Dated: January 31, 2008.
of Mexico.’’ The guidance sets forth the neurological symptoms can persist for Jeffrey Shuren,
agency’s recommendations for ensuring months to years. Assistant Commissioner for Policy.
the safety of grouper, amberjack, and FDA is issuing this guidance as level [FR Doc. 08–537 Filed 2–1–08; 4:38 pm]
related predatory reef species captured 1 guidance consistent with FDA’s good BILLING CODE 4160–01–S
in the northern Gulf of Mexico with guidance practices regulation (§ 10.115
respect to ciguatera fish poisoning (21 CFR 10.115)). Consistent with FDA’s
(CFP). The guidance is in response to good guidance practices regulation, the DEPARTMENT OF HEALTH AND
recent cases of CFP that have occurred agency will accept comment, but is HUMAN SERVICES
in the United States. implementing the guidance document
DATES: This guidance is final February immediately in accordance with Food and Drug Administration
6, 2008. Submit written or electronic § 10.115(g) (2) because the agency has [FDA No. 225–07–8007]
comments on the guidance document at determined that prior public
any time. participation is not feasible or Memorandum of Understanding
ADDRESSES: Submit written comments appropriate in light of the need to Between the Food and Drug
on the guidance to the Division of respond expeditiously to the recent Administration and the National
pwalker on PROD1PC71 with NOTICES
Dockets Management (HFA–305), Food cases of CFP. The guidance represents Institutes of Health
and Drug Administration, 5630 Fishers the agency’s current thinking on CFP AGENCY: Food and Drug Administration,
Lane, rm. 1061, Rockville, MD 20852. from fish in the Northern Gulf of HHS.
Submit electronic comments to http:// Mexico. It does not create or confer any
ACTION: Notice.
www.regulations.gov. Submit written rights for or on any person and does not
VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\06FEN1.SGM 06FEN1
6974 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices
SUMMARY: The Food and Drug the development of at least two Programs, Food and Drug
Administration (FDA) is providing products: (1) A Rational Questionnaire, Administration, 5600 Fishers Lane (HF–
notice of a memorandum of an interactive help system that will 18), Rockville, MD 20785, 301–827–
understanding (MOU) between FDA and assist reporters of information in 7868.
the National Institutes of Health (NIH). determining what specific data need to SUPPLEMENTARY INFORMATION: In
This MOU establishes the terms of be submitted and to whom, and (2) a accordance with 21 CFR 20.108(c),
collaboration between the two Federal prototype to test the feasibility of a which states that all written agreements
agencies to develop a unified Federal central, Federal web-based portal to and MOUs between FDA and others
approach to adverse event (AE) provide direct, seamless, online shall be published in the Federal
reporting. Specifically, FDA and NIH submission of adverse event reports to Register, the agency is publishing notice
will collaborate in development of a appropriate agencies. of this MOU.
project that will result in a web-based
DATES:The agreement became effective Dated: January 28, 2008.
method for consumers, health
September 27, 2007. Jeffrey Shuren,
professionals, investigators, sponsors,
and other parties to electronically FOR FURTHER INFORMATION CONTACT: Assistant Commissioner for Policy.
submit AE reports. The project includes Daryl Allis, OC/Office of Critical Path BILLING CODE 4160–01–S
Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 6975
EN06FE08.115</GPH>
EN06FE08.116</GPH>
EN06FE08.117</GPH>
EN06FE08.118</GPH>
EN06FE08.119</GPH>
EN06FE08.120</GPH>
EN06FE08.121</GPH>
[FR Doc. 08–496 Filed 2–5–08; 8:45 am] OMB for review, call the HRSA Reports individuals in HRSA responsible for
BILLING CODE 4160–01–C Clearance Office on (301)–443–1129. making award decisions.
The following request has been To streamline the selection and
submitted to the Office of Management assignment of expert grant reviewers to
DEPARTMENT OF HEALTH AND and Budget for review under the objective review committees, HRSA
HUMAN SERVICES Paperwork Reduction Act of 1995: utilizes a Web-based data collection
Proposed Project: The Division of form to gather critical reviewer
Health Resources and Services
Independent Review Grant Reviewer information. The Grant Reviewer
Administration
Recruitment Form (OMB No. 0915– Recruitment Form standardizes
Agency Information Collection 0295): Extension pertinent categories of reviewer
Activities: Submission for OMB HRSA’s Division of Independent information, such as: Areas of expertise,
Review; Comment Request Review (DIR) is responsible for carrying occupations, work settings; reviewer
out the independent and objective experience, and allows maximum use of
Periodically, the Health Resources review of all eligible applications drop-down menus to simplify the data
and Services Administration (HRSA) submitted to HRSA. DIR ensures that collection process. The Web-based
publishes abstracts of information the independent review process is system also permits reviewers to update
collection requests under review by the efficient, effective, economical, and their information as needed. HRSA
Office of Management and Budget complies with statutes, regulations, and maintains a pool of approximately 5,500
(OMB), in compliance with the policies. The review of applications is individuals that have previously served
Paperwork Reduction Act of 1995 (44 performed by experts knowledgeable in on HRSA objective review committees.
U.S.C. Chapter 35). To request a copy of the field of endeavor for which support The estimated annual burden is as
the clearance requests submitted to is requested and is advisory to follows:
Responses
Number of Total Hours per Total burden
Grant recruitment form per
respondents responses response hours
respondent
New reviewer ....................................................................... 2,200 1 2,200 45 min. 1,650

Updating reviewer information ............................................. 250 1 250 20 min. 84
Total .............................................................................. 2,450 ........................ 2,450 ........................ 1,734
Written comments and the discussions could disclose DEPARTMENT OF HEALTH AND
recommendations concerning the confidential trade secrets or commercial HUMAN SERVICES
proposed information collection should property such as patentable material,
be sent within 30 days of this notice to and personal information concerning National Institutes of Health
the desk officer for HRSA, either by e- individuals associated with the grant
mail to OIRA_submission@omb.eop.gov applications, the disclosure of which National Heart, Lung, and Blood
or by fax to 202–395–6974. Please direct would constitute a clearly unwarranted Institute; Amended Notice of Meeting
all correspondence to the ‘‘attention of invasion of personal privacy.
the desk officer for HRSA.’’ Notice is hereby given of a change in
Name of Committee: National Center for the meeting of the National Heart, Lung,
Dated: January 30, 2008. Complementary and Alternative Medicine
Alexandra Huttinger,
and Blood Institute Special Emphasis
Special Emphasis Panel, Clinical Sciences— Panel, February 20, 2008, 8 a.m. to
Acting Director, Division of Policy Review member conflict (PA06–510).
and Coordination. February 21, 2008, 1 p.m., Courtyard
Date: February 26, 2008.
[FR Doc. E8–2157 Filed 2–5–08; 8:45 am]
Marriott, 2899 Jefferson Davis Highway,
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
Arlington, VA, 22202 which was
BILLING CODE 4165–15–P
applications. published in the Federal Register on
Place: Embassy Suites at the Chevy Chase January 28, 2008, FR08–298.
DEPARTMENT OF HEALTH AND Pavillion, 4300 Military Road, NW., The meeting dates were changed from
HUMAN SERVICES Washington, DC 20015. February 20–21, 2008 to February 21–
Contact Person: Martin H. Goldrosen, PhD, 22, 2008. The rest of the information
National Institutes of Health Director, Office of Scientific Review, remains the same. The meeting is closed
National Center for Complementary and to the public.
National Center for Complementary & Alternative Medicine, National Institutes of
Alternative Medicine; Notice of Closed Health, 6707 Democracy Blvd., Ste. 106, Dated: January 30, 2008.
Meeting Bethesda, MD 20892–5475, (301) 451–6331, Jennifer Spaeth,
Pursuant to section 10(d) of the goldrosm@mail.nih.gov. Director, Office of Federal Advisory
Federal Advisory Committee Act, as Dated: January 30, 2008. Committee Policy.
amended (5 U.S.C. Appendix 2), notice Jennifer Spaeth,
[FR Doc. 08–504 Filed 2–5–08; 8:45 am]
is hereby given of the following BILLING CODE 4140–01–M
Director, Office of Federal Advisory
meeting.
Committee Policy.
The meeting will be closed to the
public in accordance with the [FR Doc. 08–507 Filed 2–5–08; 8:45 am]
provisions set forth in sections BILLING CODE 4140–01–M
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and

Notice: Guidance For Industry Fish and Fisheries Products Hazards and Controls: National Institutes of Health

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Federal Register / Vol. 73, No.

25 / Wednesday, February 6, 2008 / Notices 6973

New reviewer ....................................................................... 2,200 1 2,200 45 min. 1,650

Total .............................................................................. 2,450 ........................ 2,450 ........................ 1,734

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