Compliance Policy Guide Sec. 540.370-Fish and Fishery Products-Decomposition; Availability, 4039-4040 [E9-1142]

Download as PDF 4039 Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices additional three-year period. Responses will be submitted electronically using a web-based survey instrument. Minor changes to the instrument are proposed to address compliance with recommendations made in the updated PHS clinical practice guideline issued in May of 2008, such as coverage for combination therapies, smokeless tobacco use, and states’ familiarity with and use of the 2000 PHS guideline. The minor changes are not expected to affect the overall burden estimate. To minimize burden, each respondent will only be asked to record changes that occurred since the time of the previous submission. As in previous years, each respondent will also attach a copy of the state’s Medicaid coverage plan to their completed survey, in order to assist the research team with the interpretation of responses. The information to be collected will allow CDC to continue monitoring compliance with the most recent PHS recommendations and the progress of State Medicaid Programs toward the 2010 National Health Objectives and Healthy People 2010 goals. There are no costs to respondents except the time to complete the survey. The total estimated burden hours are 26. ESTIMATED ANNUALIZED BURDEN HOURS Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) State Medicaid Programs ............................................................................................................ 51 1 30/60 Dated: January 13, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–1227 Filed 1–21–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) Announces an Evaluation of Downdraft Vented Nail Salon Tables (VNTs) Authority: 29 U.S.C. Sections 651 et seq. AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. The Division of Applied Research and Technology (DART), NIOSH, is conducting an evaluation of downdraft vented salon nail tables (VNTs). This notice invites developers, manufacturers, and vendors of VNTs to submit new, unused, downdraft VNTs for evaluation of operational characteristics and effectiveness in reducing levels of a source point tracer gas at standard distances from the vent. A 6-month supply of manufacturer recommended filters is to be submitted to NIOSH at the address below, together with the VNT. Evaluation parameters for the VNTs will include, but are not limited to: rmajette on PRODPC74 with NOTICES SUMMARY: VerDate Nov<24>2008 14:47 Jan 21, 2009 Jkt 217001 Airflow and capture characteristics, noise level, ergonomic features, and filter life. Manufacturers, vendors, and developers who wish to submit VNTs with filters for evaluation are invited to respond to this announcement. A report on each VNT submitted for evaluation, including feedback on the evaluation parameters and staff recommendations, will be sent to the submitter. Results of the evaluation will potentially be used to develop educational materials for nail technicians and may also be disseminated through reports, publications, or presentations. NIOSH does not intend to identify manufacturers in its publications but testing information referencing particular manufacturers would be releasable if requested under the Freedom of Information Act (FOIA). DATES: Written letter of interest must be received within 90 calendar days of publication in the Federal Register. The deadline for receipt of VNT and filter submissions is June 30, 2009. Evaluations will begin subject to the dates VNT and filter submissions are received. The VNTs will be retained for up to 10 months while being evaluated, after which they will be returned. ADDRESSES: Manufacturers, vendors, and developers who wish to submit VNTs with filters for evaluation are invited to respond to this announcement by sending a written letter of interest to NIOSH/DART, Robert A. Taft Laboratories, 4676 Columbia Parkway, Mailstop C–23, Cincinnati, Ohio 45226, Attention: Susan Reutman, e-mail address: SReutman@cdc.gov. SUPPLEMENTARY INFORMATION: Responses shall include: A description of the VNT including the manufacturer, schedule of availability of the VNT and filters for evaluation, and a statement of the terms PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 under which the VNT will be made available for evaluation. Shipping and handling costs (including insurance) to ship the VNTs to NIOSH and for NIOSH to return the VNTs to the submitter will be the responsibility of the submitter. NIOSH reserves the right to decide which VNT submissions will be evaluated based on compliance with the specifications described above. NIOSH also reserves the right not to proceed in this manner. Note: As a government entity, we cannot endorse any specific product directly, indirectly, or by implication. NIOSH will not be responsible for any costs related to usage, wear and tear or accidental damage to the VNT during transport or while the VNT is at NIOSH. Contact Person for Technical Information: Susan Reutman, Ph.D., telephone (513) 533–8286, or e-mail SReutman@cdc.gov. Dated: January 2, 2009. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E9–1193 Filed 1–21–09; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0264] Compliance Policy Guide Sec. 540.370—Fish and Fishery Products— Decomposition; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the E:\FR\FM\22JAN1.SGM 22JAN1 4040 Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices rmajette on PRODPC74 with 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 https:// 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 VerDate Nov<24>2008 14:47 Jan 21, 2009 Jkt 217001 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 https://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the CPG at https://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] 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 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 Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of Class Deviation from Project/Budget Period Funding Policies. AGENCY: 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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 ............ $491,265 884,277 393,012 412,663 451,964 491,265 393,012 432,313 451,964 451,964 439,825 604,256 393,011 393,012 393,012 481,440 442,139 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. E:\FR\FM\22JAN1.SGM 22JAN1

Agencies

[Federal Register Volume 74, Number 13 (Thursday, January 22, 2009)]
[Notices]
[Pages 4039-4040]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1142]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0264]


Compliance Policy Guide Sec. 540.370--Fish and Fishery Products--
Decomposition; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the

[[Page 4040]]

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 https://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 https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the CPG at https://
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

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