Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 6973 

to CMS. The burden associated with this 

requirement is currently approved 

under OMB control number 0938–0880 

with an expiration date of November 20, 

2010. 

Authority: Section 410A of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003, Pub. L. No. 108–

173. (Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). 

Dated: January 11, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 08–511 Filed 2–1–08; 10:00 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0079] 

Guidance for Industry: Fish and 

Fisheries Products Hazards and 

Controls Guidance Third Edition June 

2001: Letter to Seafood Processors 

that Purchase Grouper, Amberjack, 

and Related Predatory Reef Species 

Captured in the Northern Gulf of 

Mexico 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Fish and Fisheries Products 

Hazards and Controls Guidance, Third 

Edition June 2001: Letter to Seafood 

Processors that Purchase Grouper, 

Amberjack and Related Predatory Reef 

Species Captured in the Northern Gulf 

of Mexico.’’ The guidance sets forth the 

agency’s recommendations for ensuring 

the safety of grouper, amberjack, and 

related predatory reef species captured 

in the northern Gulf of Mexico with 

respect to ciguatera fish poisoning 

(CFP). The guidance is in response to 

recent cases of CFP that have occurred 

in the United States. 

DATES: This guidance is final February 

6, 2008. Submit written or electronic 

comments on the guidance document at 

any time. 

ADDRESSES: Submit written comments 

on the 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. Submit written 

requests for single copies of the 

guidance to the Office of Food Safety 

(HFS–317), Center for Food Safety and 

Applied Nutrition, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

one self-addressed adhesive label to 

assist the office in processing your 

request, or fax your request to 301–436–

2651. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Byron Truglio, Center for Food Safety 

and Applied Nutrition (HFS–325), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1420. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance document entitled ‘‘Fish and 

Fisheries Products Hazards and Controls 

Guidance, Third Edition June 2001: 

Letter to Seafood Processors that 

Purchase Grouper, Amberjack and 

Related Predatory Reef Species 

Captured in the Northern Gulf of 

Mexico.’’ The purpose of the document 

is to revise guidance provided to 

industry for processing potentially 

ciguatoxic fish species captured in the 

northern Gulf of Mexico which are 

subject to the provisions of the Hazard 

Analysis and Critical Control Point 

regulation for seafood (21 CFR part 123) 

(the seafood HACCP regulation). This 

guidance is in response to recent CFP 

outbreaks that have been traced to fish 

captured in an area in the United States 

where ciguatera was previously 

extremely rare. CFP is caused by 

consumption of fish that have eaten 

toxic marine algae directly or that have 

eaten other toxin-contaminated fish. 

CFP can result in gastrointestinal, 

cardiovascular, and neurological 

symptoms. In severe cases, recurring 

neurological symptoms can persist for 

months to years. 

FDA is issuing this guidance as level 

1 guidance consistent with FDA’s good 

guidance practices regulation (§ 10.115 

(21 CFR 10.115)). Consistent with FDA’s 

good guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately in accordance with 

§ 10.115(g) (2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the recent 

cases of CFP. The guidance represents 

the agency’s current thinking on CFP 

from fish in the Northern Gulf of 

Mexico. 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. This guidance modifies 

our previous guidance on this subject 

(See ‘‘Fish and Fisheries Products 

Hazards and Controls Guidance, Third 

Edition June 2001’’ http:// 

www.cfsan.fda.gov/guidance.html). The 

recommendations in this guidance only 

pertain to grouper, amberjack, and 

related predatory reef species associated 

with CFP that have been captured in the 

Northern Gulf of Mexico. This guidance 

does not pertain to other species of fish 

that have not been associated with CFP. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this guidance. 

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 guidance 

and received comments may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance document at 

http://www.cfsan.fda.gov/ 

guidance.html. 

Dated: January 31, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 08–537 Filed 2–1–08; 4:38 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA No. 225–07–8007] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the National 

Institutes of Health 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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6974 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the National Institutes of Health (NIH). 

This MOU establishes the terms of 

collaboration between the two Federal 

agencies to develop a unified Federal 

approach to adverse event (AE) 

reporting. Specifically, FDA and NIH 

will collaborate in development of a 

project that will result in a web-based 

method for consumers, health 

professionals, investigators, sponsors, 

and other parties to electronically 

submit AE reports. The project includes 

the development of at least two 

products: (1) A Rational Questionnaire, 

an interactive help system that will 

assist reporters of information in 

determining what specific data need to 

be submitted and to whom, and (2) a 

prototype to test the feasibility of a 

central, Federal web-based portal to 

provide direct, seamless, online 

submission of adverse event reports to 

appropriate agencies. 

DATES: The agreement became effective 

September 27, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Daryl Allis, OC/Office of Critical Path 

Programs, Food and Drug 

Administration, 5600 Fishers Lane (HF–

18), Rockville, MD 20785, 301–827–

7868. 

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: January 28, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


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[FR Doc. 08–496 Filed 2–5–08; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301)–443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: The Division of 

Independent Review Grant Reviewer 

Recruitment Form (OMB No. 0915–

0295): Extension 

HRSA’s Division of Independent 

Review (DIR) is responsible for carrying 

out the independent and objective 

review of all eligible applications 

submitted to HRSA. DIR ensures that 

the independent review process is 

efficient, effective, economical, and 

complies with statutes, regulations, and 

policies. The review of applications is 

performed by experts knowledgeable in 

the field of endeavor for which support 

is requested and is advisory to 

individuals in HRSA responsible for 

making award decisions. 

To streamline the selection and 

assignment of expert grant reviewers to 

objective review committees, HRSA 

utilizes a Web-based data collection 

form to gather critical reviewer 

information. The Grant Reviewer 

Recruitment Form standardizes 

pertinent categories of reviewer 

information, such as: Areas of expertise, 

occupations, work settings; reviewer 

experience, and allows maximum use of 

drop-down menus to simplify the data 

collection process. The Web-based 

system also permits reviewers to update 

their information as needed. HRSA 

maintains a pool of approximately 5,500 

individuals that have previously served 

on HRSA objective review committees. 

The estimated annual burden is as 

follows: 

Grant recruitment form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

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 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’

Dated: January 30, 2008. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E8–2157 Filed 2–5–08; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel, Clinical Sciences—

member conflict (PA06–510). 

Date: February 26, 2008. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavillion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Martin H. Goldrosen, PhD, 

Director, Office of Scientific Review, 

National Center for Complementary and 

Alternative Medicine, National Institutes of 

Health, 6707 Democracy Blvd., Ste. 106, 

Bethesda, MD 20892–5475, (301) 451–6331, 

goldrosm@mail.nih.gov. 

Dated: January 30, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–507 Filed 2–5–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Heart, Lung, 

and Blood Institute Special Emphasis 

Panel, February 20, 2008, 8 a.m. to 

February 21, 2008, 1 p.m., Courtyard 

Marriott, 2899 Jefferson Davis Highway, 

Arlington, VA, 22202 which was 

published in the Federal Register on 

January 28, 2008, FR08–298. 

The meeting dates were changed from 

February 20–21, 2008 to February 21–

22, 2008. The rest of the information 

remains the same. The meeting is closed 

to the public. 

Dated: January 30, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–504 Filed 2–5–08; 8:45 am] 

BILLING CODE 4140–01–M 


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