4040 Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices 

availability of Compliance Policy Guide 

Sec. 540.370—Fish and Fishery 

Products—Decomposition (the CPG). 

The CPG provides guidance for FDA 

staff on decomposition in fish and 

fishery products. 

DATES: Submit written or electronic 

comments on the CPG at any time. 

ADDRESSES: Submit written comments 

on the CPG 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 CPG to 

the Division of Compliance Policy 

(HFC–230), Office of Enforcement, 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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the CPG. 

FOR FURTHER INFORMATION CONTACT: 

Robert D. Samuels, Center for Food 

Safety and Applied Nutrition (HFS– 

325), Food and Drug Administration, 

100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 18, 

2008 (73 FR 41361), FDA announced the 

availability of draft CPG Sec. 540.370— 

Fish and Fishery Products— 

Decomposition and gave interested 

parties an opportunity to submit 

comments. The agency received no 

comments on the draft CPG but on its 

own initiative made a few editorial 

changes for clarification purposes. The 

CPG provides guidance for FDA staff on 

decomposition in fish and fishery 

products. The CPG also contains 

information that may be useful to the 

regulated industry and to the public. 

FDA is issuing this CPG as a level 1 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The CPG represents the 

agency’s current thinking on FDA’s 

direct reference enforcement criteria 

related to decomposition in fish and 

fishery products. 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. 

II. 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 CPG 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 Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the CPG at http://www.fda.

gov/ora/compliance_ref/cpg/

default.htm. 

Dated: January 12, 2009. 

Michael A. Chappell, 

Acting Associate Commissioner for 

Regulatory Affairs. 

[FR Doc. E9–1142 Filed 1–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Leadership Education in 

Neurodevelopmental and Other 

Related Disabilities MCH Training 

Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Class Deviation from 

Project/Budget Period Funding Policies. 

SUMMARY: HRSA will provide 2 

additional years of support in the 

absence of competition for one cohort of 

grants under the Leadership Education 

in Neurodevelopmental and Other 

Related Disabilities (LEND) MCH 

Training Program. HRSA will extend the 

project period to June 30, 2011, for the 

cohort of the LEND program expected to 

compete in fiscal year (FY) 2009, which 

would correspond to the sunset of the 

Combating Autism Act. Currently, there 

are 34 LEND grants split into two 

cohorts (17 each) with different end 

dates; one group is scheduled to 

compete in FY 2009 (Cohort A), and the 

other in FY 2011 (Cohort B). HRSA will 

non-competitively extend with funds 

the 5-year project periods for those 

LEND grantees ending on June 30, 2009, 

for 2 additional budget periods at the 

same level of support for the same scope 

of activities which they received in FY 

2008. 

SUPPLEMENTARY INFORMATION: 

Intended Recipients of the Award 

Seventeen programs in the LEND 

cohort are expected to compete in FY 

2009. These programs presently have 

active LEND grants: University of Iowa, 

Johns Hopkins University, University of 

Missouri, University of Nebraska, 

Dartmouth Hitchcock Medical Center, 

Albert Einstein College of Medicine, 

Children’s Hospital of Pittsburgh, 

University of South Dakota, University 

of Vermont, Virginia Commonwealth 

University, West Virginia University, 

University of Massachusetts Medical 

School, Ohio State University, 

Vanderbilt University, Children’s 

Research Institute, Indiana University, 

University of Oklahoma. 

Amount of Individual Supplemental 

Awards: Note: These funding levels are 

expected to continue in FYs 2009 and 

2010. 

Grantee FY 2008 

award 

University of Iowa ..................... $491,265 

Johns Hopkins University ......... 884,277 

University of Missouri ............... 393,012 

University of Nebraska ............. 412,663 

Dartmouth Hitchcock Medical 

Center ................................... 451,964 

Albert Einstein College of Medicine ........................................ 491,265 

Children’s Hospital of Pittsburgh ..................................... 393,012 

University of South Dakota ....... 432,313 

University of Vermont ............... 451,964 

Virginia Commonwealth University ......................................... 451,964 

West Virginia University ........... 439,825 

University of Massachusetts 

Medical School ...................... 604,256 

Ohio State University ................ 393,011 

Vanderbilt University ................. 393,012 

Children’s Research Institute ... 393,012 

Indiana University ..................... 481,440 

University of Oklahoma ............ 442,139 

Current Project Periods: 7/1/04 

through 6/30/09. 

Period of Supplemental Funding: 

7/1/09 through 6/30/11. 

Authority: Combating Autism Act of 2006, 

Public Law No. 109–416, § 399BB(e)(1)(A), 

120 Stat 2821, 2826 (2006). 

CFDA Number: 93.110. 

FOR FURTHER INFORMATION CONTACT: 

Laura Kavanagh; Branch Chief, MCH 

Training Program, Division of Research, 

Training and Education; Maternal and 

Child Health Bureau; (301) 443–2254. 


rmajette on PRODPC74 with NOTICES
Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices 4041 

Justification for the Exception to 

Competition: HRSA is ending the two 

cohort system for the following reason: 

The Combating Autism Act of 2006 is 

scheduled to sunset in September of 2011. 

With this legislation, it is critical to have 

sufficient and accurate data to evaluate the 

progress of screening and diagnosing a 

greater number of children with autism 

spectrum disorder (ASD) and other 

developmental disabilities and assuring that 

they receive evidenced based services. A 

national evaluation will be conducted to 

contribute to the HHS Secretary’s Report to 

Congress on progress related to ASD and 

other developmental disabilities as required 

by the Combating Autism Act. From a 

programmatic perspective, it is imperative to 

collect data from the same group of grantees 

over the project period to assess program 

goals as requested in the National Evaluation. 

By extending the project period for two 

additional years for the LEND cohort with the 

current project period ending date of June 30, 

2009, MCHB will be able to collect common 

data elements from both LEND cohorts 

through the end of Combating Autism Act 

which sunsets in 2011. Doing so will help 

ensure that there will be a more cohesive and 

uniform collection of data being gathered and 

analyzed across both cohorts which will 

increase sample size and ultimately, data 

validity and study power. If it becomes 

necessary to hold a competition for the LEND 

cohort in FY 2009 and new applicants were 

to apply and be successful, there would be 

the potential for less uniformity in the data 

collection. It is crucial that there is as much 

meaningful data gathered in the remaining 

time available from both cohorts to ensure 

that the National Evaluation is an accurate 

reflection of the program activities. 

Under this deviation, MCHB will 

provide the LEND grantees in LEND 

Cohort A, currently expected to compete 

in FY 2009, with the same amount of 

funds for the same scope of activities 

that they received in FY 2008 for both 

the FY2009 and 2010 budget periods. 

Dated: January 13, 2009. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E9–1236 Filed 1–21–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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 

meetings. 

The meetings 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: Center for Scientific 

Review Special Emphasis Panel Multiscale 

Models of the Physiome. 

Date: January 29–30, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Malgorzata Klosek, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4188, 

MSC 7849, Bethesda, MD 20892, (301) 435– 

2211, klosekm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering, 

Integrated Review Group Biomedical Imaging 

Technology Study Section. 

Date: February 2–3, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Guest Suites Doheny 

Beach, 34402 Pacific Coast Highway, Dana 

Point, CA 92629. 

Contact Person: Lee Rosen, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5116, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1171, rosenl@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Oncological Sciences 

Integrated Review Group, Tumor 

Microenvironment Study Section. 

Date: February 2–3, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont Washington, DC, 2401 

M Street, NW., Washington, DC 20037. 

Contact Person: Eun Ah Cho, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6202, 

MSC 7804, Bethesda, MD 20892, (301) 451– 

4467, choe@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences, Integrated Review Group, 

Musculoskeletal Tissue Engineering Study 

Section. 

Date: February 2–3, 2009. 

Time: 8 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bahia Resort Hotel, 998 West 

Mission Bay Drive, San Diego, CA 92109. 

Contact Person: Jean D. Sipe, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4106, 

MSC 7814, Bethesda, MD 20892, 301/435– 

1743, sipej@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Biology of 

Development and Aging Integrated Review 

Group, Development—2 Study Section. 

Date: February 5, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The River Inn, 924 25th Street, NW., 

Washington, DC 20037. 

Contact Person: Neelakanta Ravindranath, 

Ph.D., MVSC, Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Room 5140, MSC 7843, Bethesda, MD 20892, 

301–435–1034, ravindrn@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Immunology 

Integrated Review Group, Innate Immunity 

and Inflammation Study Section. 

Date: February 5–6, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Westin St. Francis, 335 Powell 

Street, San Francisco, CA 94102. 

Contact Person: Tina Mcintyre, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4202, 

MSC 7812, Bethesda, MD 20892, 301–594– 

6375, mcintyrt@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Infectious Diseases 

and Microbiology, Integrated Review Group, 

Clinical Research and Field Studies of 

Infectious Diseases Study Section. 

Date: February 6, 2009. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: St. Gregory Hotel, 2033 M Street, 

NW., Washington, DC 20036. 

Contact Person: Soheyla Saadi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3211, 

MSC 7808, Bethesda, MD 20892, 301–435– 

0903, saadisoh@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience, Integrated Review 

Group, Clinical Neuroplasticity and 

Neurotransmitters Study Section. 

Date: February 9–10, 2009. 


rmajette on PRODPC74 with NOTICES