Compliance Policy Guide Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces; Availability, 16861-16862 [E8-6504]

Download as PDF 16861 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447. Attn: ACF Reports Clearance Officer. E-mail address: OPRElfoCollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 20, 2008. Brendan C. Kelly, OPRE Reports Clearance Officer. [FR Doc. E8–6340 Filed 3–28–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Title: HHS/ACF/OPRE Head Start Classroom-based Approaches and Resources for Emotion and Social skill promotion (CARES) project: Site Recruitment Materials. OMB No.: New Collection. Description: The Head Start Classroom-based Approaches and Resources for Emotion and Social skill promotion (CARES) project will evaluate program enhancements within Head Start settings serving three- and four-year-old children. This project focuses on identifying the central features of effective programs to provide the information Federal policy makers and Head Start providers will need if they are to increase Head Start’s capacity to improve the social and emotional skills and school readiness of preschool-age children. The project is sponsored by the Office of Planning, Research and Evaluation (OPRE) of the Administration for Children and Families (ACF), part of the Department of Health and Human Services (HHS). The Head Start CARES project will use a group-based randomized design to test the effects of several different evidence-based strategies designed to improve the social and emotional development of children in Head Start classrooms. The purpose of the proposed information collection is to recruit Head Start grantees to participate in the project, through informing grantee staff about the project, soliciting their interest in participating, and collecting information to assess their programs’ eligibility to participate in the project. Respondents: Respondents will include staff in Head Start grantee and delegate agencies. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response Total burden hours 40 40 130 1 1 1 .5 1 2 20 40 260 Estimated Total Annual Burden Hours: .................................................... mmaher on PROD1PC76 with NOTICES Project Description ........................................................................................... Phone Discussion Points & Screener ............................................................. Discussion Guide for Site Visits ...................................................................... ........................ ........................ ........................ 320 In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: OPREInfoCollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have VerDate Aug<31>2005 18:00 Mar 28, 2008 Jkt 214001 practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: March 20, 2008. Brendan C. Kelly, OPRE Reports Clearance Officer. [FR Doc. E8–6343 Filed 3–28–08; 8:45 am] HHS. BILLING CODE 4184–01–M PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2008–D–0143] (formerly Docket No. 2006D–0056) Compliance Policy Guide Sec. 500.500 Guidance Levels for 3–MCPD (3chloro-1, 2-propanediol) in AcidHydrolyzed Protein and Asian-Style Sauces; Availability AGENCY: ACTION: Food and Drug Administration, Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of compliance policy guide (CPG) Sec. 500.500 Guidance Levels for 3–MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed Protein and AsianStyle Sauces. The CPG provides regulatory action guidance for FDA staff regarding 3–MCPD in acid-hydrolyzed E:\FR\FM\31MRN1.SGM 31MRN1 16862 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices mmaher on PROD1PC76 with NOTICES protein (acid-HP) and Asian-style sauces. DATES: Submit written or electronic comments regarding 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 CPG Sec. 500.500 Guidance Levels for 3–MCPD (3-chloro-1,2propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces to the Division of Compliance Policy (HFC– 230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632– 6860. 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 document. FOR FURTHER INFORMATION CONTACT: Judith L. Kidwell, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 20740–3835, 301–436–1071. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of May 23, 2006 (71 FR 29651), FDA announced the availability of draft CPG Sec. 500.500 Guidance Levels for 3–MCPD (3-chloro1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces. FDA received one comment on the draft CPG. The International Hydrolyzed Protein Council (IHPC) offered clarification for the following sentence found in the BACKGROUND section of the draft CPG: ‘‘Since 1996, many countries * * * have recommended or required that industry take steps to ensure that 3– MCPD is not detectable in acid-HP or Asian-style sauces at levels ranging from 0.01 parts per million (ppm) to 1 ppm.’’ IHPC suggested that we revise the sentence as follows: ‘‘Since 1996, many countries * * * have recommended or required that industry take steps to ensure that 3–MCPD in acid-HP or Asian-style sauces does not exceed levels ranging from 0.01 parts per million (ppm) to 1 ppm.’’ IHPC explained that using the phrase ‘‘not detectable’’ and then listing allowable levels is confusing. We concur with the comment and have revised the final CPG accordingly. FDA also revised the SPECIMEN CHARGES section in the VerDate Aug<31>2005 18:00 Mar 28, 2008 Jkt 214001 final CPG to provide operational guidance regarding reference to the United States Code (U.S.C.) when citing the violation charged in a domestic seizure and reference to the Federal Food, Drug, and Cosmetic Act when citing the violation charged in an import detention. We also have made other editorial changes to the CPG for clarification. This CPG is being issued as level 1 guidance consistent with FDA’s good guidance practices regulations (21 CFR 10.115). The CPG represents the agency’s current thinking on 3–MCPD in acid-HP and Asian-style sauces. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate 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 on the CPG at any time. 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 through FDMS only. III. Electronic Access Persons with access to the Internet may obtain the CPG from the Office of Regulatory Affairs home page at https:// www.fda.gov/ora under ‘‘Compliance Reference.’’ Dated: March 14, 2008. Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs. [FR Doc. E8–6504 Filed 3–28–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Office of Clinical and Preventive Services; Elder Care Initiative LongTerm Care Grant Program Announcement Type: New. Funding Announcement Number: HHS–2008–IHS–EHC–0001. Catalog of Federal Domestic Assistance Numbers: 93.933. Key Dates: Letter of Intent Deadline: May 2, 2008. Application Deadline Date: June 20, 2008. Review Date: July 21–August 1, 2008. Earliest Anticipated Start Date: September 1, 2008. I. Funding Opportunity Description The Indian Health Service (IHS) announces the availability of up to $600,000 for competitive grants through the Elder Care Initiative Long Term Care (ECILTC) Grant Program to support planning and implementation of sustainable long-term care services for American Indians and Alaska Native (AI/AN) elders. This program is authorized under the Snyder Act, Indian Health Care Improvement Act, as amended, 25 U.S.C. 1653(c), and Public Health Service Act, Section 301, as amended. This program is described at 93.933 in the Catalog of Federal Domestic Assistance (CFDA). The AI/AN elder population is growing rapidly and the Al/AN population as a whole is aging. The prevalence of chronic disease in this population continues to increase, contributing to a frail elder population with increasing long-term care (LTC) needs. LTC is best understood as an array of social and health care services that support an individual who has needs for assistance in activities of daily living over a prolonged period. LTC supports elders and their families with medical, personal, and social services delivered in a variety of settings to support quality of life, maximum function, and dignity. While families continue to be the backbone of LTC for Al/AN elders, there is well documented need to support this care with formal services. The way these services and systems of care are developed and implemented can have a profound impact on the cultural and spiritual health of the community. Home and community-based services have the potential for meeting the needs of the vast majority of elders requiring LTC services, supporting the key roles of the family in the care of the elder and E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Notices]
[Pages 16861-16862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6504]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0143] (formerly Docket No. 2006D-0056)


Compliance Policy Guide Sec. 500.500 Guidance Levels for 3-MCPD 
(3-chloro-1, 2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style 
Sauces; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of compliance policy guide (CPG) Sec. 500.500 Guidance 
Levels for 3-MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed 
Protein and Asian-Style Sauces. The CPG provides regulatory action 
guidance for FDA staff regarding 3-MCPD in acid-hydrolyzed

[[Page 16862]]

protein (acid-HP) and Asian-style sauces.

DATES: Submit written or electronic comments regarding 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 CPG Sec. 500.500 
Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-
Hydrolyzed Protein and Asian-Style Sauces to the Division of Compliance 
Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 240-632-6860. 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 document.

FOR FURTHER INFORMATION CONTACT: Judith L. Kidwell, Office of Food 
Additive Safety, Center for Food Safety and Applied Nutrition (HFS-
265), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD, 20740-3835, 301-436-1071.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 23, 2006 (71 FR 29651), FDA 
announced the availability of draft CPG Sec. 500.500 Guidance Levels 
for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and 
Asian-Style Sauces. FDA received one comment on the draft CPG. The 
International Hydrolyzed Protein Council (IHPC) offered clarification 
for the following sentence found in the BACKGROUND section of the draft 
CPG: ``Since 1996, many countries * * * have recommended or required 
that industry take steps to ensure that 3-MCPD is not detectable in 
acid-HP or Asian-style sauces at levels ranging from 0.01 parts per 
million (ppm) to 1 ppm.'' IHPC suggested that we revise the sentence as 
follows: ``Since 1996, many countries * * * have recommended or 
required that industry take steps to ensure that 3-MCPD in acid-HP or 
Asian-style sauces does not exceed levels ranging from 0.01 parts per 
million (ppm) to 1 ppm.'' IHPC explained that using the phrase ``not 
detectable'' and then listing allowable levels is confusing. We concur 
with the comment and have revised the final CPG accordingly. FDA also 
revised the SPECIMEN CHARGES section in the final CPG to provide 
operational guidance regarding reference to the United States Code 
(U.S.C.) when citing the violation charged in a domestic seizure and 
reference to the Federal Food, Drug, and Cosmetic Act when citing the 
violation charged in an import detention. We also have made other 
editorial changes to the CPG for clarification.
    This CPG is being issued as level 1 guidance consistent with FDA's 
good guidance practices regulations (21 CFR 10.115). The CPG represents 
the agency's current thinking on 3-MCPD in acid-HP and Asian-style 
sauces. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternate 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 on the CPG at any time. 
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 
through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the CPG from the 
Office of Regulatory Affairs home page at https://www.fda.gov/ora under 
``Compliance Reference.''

    Dated: March 14, 2008.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E8-6504 Filed 3-28-08; 8:45 am]
BILLING CODE 4160-01-S

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