Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health, 6973-6982 [08-496]

Download as PDF Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 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 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 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. pwalker on PROD1PC71 with NOTICES 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 https:// www.regulations.gov. Submit written VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 6973 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’’ https:// 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 https://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: E:\FR\FM\06FEN1.SGM Notice. 06FEN1 6974 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices pwalker on PROD1PC71 with 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 VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 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. The agreement became effective September 27, 2007. DATES: Programs, Food and Drug Administration, 5600 Fishers Lane (HF– 18), Rockville, MD 20785, 301–827– 7868. 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. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Dated: January 28, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. Daryl Allis, OC/Office of Critical Path BILLING CODE 4160–01–S PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\06FEN1.SGM 06FEN1 VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\06FEN1.SGM 06FEN1 6975 EN06FE08.115</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\06FEN1.SGM 06FEN1 EN06FE08.116</GPH> pwalker on PROD1PC71 with NOTICES 6976 VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\06FEN1.SGM 06FEN1 6977 EN06FE08.117</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\06FEN1.SGM 06FEN1 EN06FE08.118</GPH> pwalker on PROD1PC71 with NOTICES 6978 VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\06FEN1.SGM 06FEN1 6979 EN06FE08.119</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\06FEN1.SGM 06FEN1 EN06FE08.120</GPH> pwalker on PROD1PC71 with NOTICES 6980 VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\06FEN1.SGM 06FEN1 6981 EN06FE08.121</GPH> pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 6982 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 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: [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 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 Number of respondents Grant recruitment form Responses per respondent 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: Total responses Hours per response Total burden hours New reviewer ....................................................................... Updating reviewer information ............................................. 2,200 250 1 1 2,200 250 45 min. 20 min. 1,650 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 pwalker on PROD1PC71 with NOTICES 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 VerDate Aug<31>2005 18:21 Feb 05, 2008 Jkt 214001 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] 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 BILLING CODE 4140–01–M PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\06FEN1.SGM 06FEN1

Agencies

[Federal Register Volume 73, Number 25 (Wednesday, February 6, 2008)]
[Notices]
[Pages 6973-6982]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-496]


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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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[[Page 6974]]

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