Small Entity Compliance Guide: Food Labeling; Nutrient Content Claims: Definition for “High Potency” and Definition of “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods; Availability, 41363-41364 [E8-16448]

Download as PDF Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Notices Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 22, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. There will be no onsite registration. If you need special accommodations due to a disability, please contact Bernadette Kawaley (see Contact Person) at least 7 days in advance. Submit written abstracts to the contact person by August 15, 2008 (see section II of this document for additional information). SUPPLEMENTARY INFORMATION: dwashington3 on PRODPC61 with NOTICES3 I. Background FDA will explore the use of alternative methods for detecting mycoplasma contamination in the manufacture of vaccines, including pandemic influenza vaccines, and other biological products. Alternative methods that allow detection of mycoplasma in a shorter period, as compared to the current methods, could expedite the manufacture of vaccines and other biological products. The workshop is aimed at: (1) Identifying promising rapid method(s) for further validation to demonstrate equivalency or superiority to methods currently used for mycoplasma testing during the manufacture of vaccines and other biological products and (2) providing information that may lead to collaborative studies with FDA on testing for mycoplasma. The program agenda will be available at https:// www.fda.gov/cber/scireg.htm, by September 5, 2008. II. Submission of the Abstracts For purposes of discussion at the workshop, FDA is requesting submission of abstracts that describe current developments in rapid methods for detection of mycoplasma contamination during manufacture of vaccines and other biological products. FDA will select a limited number of abstracts for formal presentation at the workshop by the abstract authors. If time permits, FDA may allow additional presentations from interested persons attending the meeting who did not submit an abstract. FDA will notify authors of abstracts accepted for presentation at the workshop by August 25, 2008. Abstracts should be a maximum of 350 words, printed (typewritten or computer) and double-spaced. The title should be brief and capitalized. The authors name(s), contact information, VerDate Aug<31>2005 15:36 Jul 17, 2008 Jkt 214001 and agency, institution, or facility involved should be listed. The author who intends to present the abstract should submit a current curriculum vitae with the abstract. Dated: July 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16459 Filed 7–17–08; 8:45 am] BILLING CODE 4160–01–S 41363 label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food Safety and Applied Nutrition (HFS–810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2375. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 23, 1997 (62 FR 49868), FDA issued a final rule amending its regulations to: Food and Drug Administration Define the term ‘‘high potency’’ as a nutrient content claim; define nutrient [Docket No. FDA–1995–N–0400 (formerly Docket No. 1995N–0245), FDA–1995–N–0029 content claims using the term ‘‘antioxidant’’ (e.g., ‘‘good source of (formerly Docket No. 1995N–0282), FDA– antioxidants,’’ ‘‘high in antioxidants,’’ 1995–N–0224 (formerly Docket No. 1995N– 0347)] ‘‘more antioxidants’’) and to correct an omission pertaining to the use of ‘‘sugar Small Entity Compliance Guide: Food free’’ claims on dietary supplements. Labeling; Nutrient Content Claims: This final rule became effective March Definition for ‘‘High Potency’’ and 23, 1999.1 Definition of ‘‘Antioxidant’’ for Use in FDA examined the economic Nutrient Content Claims for Dietary implementation of the final rule as Supplements and Conventional Foods; required by the Regulatory Flexibility Availability Act (5 U.S.C. 601–602) and determined AGENCY: Food and Drug Administration, that the final rule might have a significant economic impact on a HHS. substantial number of small entities. In ACTION: Notice. compliance with section 212 of the SUMMARY: The Food and Drug Small Business Regulatory Enforcement Administration (FDA) is announcing the Fairness Act (Public Law 104–121), FDA availability of a small entity compliance is making available this SECG stating in guide (SECG) for a final rule published plain language the requirements of the in the Federal Register of September 23, regulation. 1997, entitled ‘‘Food Labeling; Nutrient FDA is issuing this SECG as level 2 Content Claims; Definition for ‘‘High guidance consistent with FDA’s good Potency’’ and Definition of guidance practices regulation (21 CFR ‘‘Antioxidant’’ for Use in Nutrient 10.115(c)(2)). The SECG represents the Content Claims for Dietary Supplements agency’s current thinking on this and Conventional Foods.’’ This SECG is subject. It does not create or confer any intended to set forth in plain language rights for or on any person and does not the requirements of the regulation and operate to bind FDA or the public. An to help small businesses understand the alternative approach may be used if regulation. such approach satisfies the requirements of the applicable statutes DATES: Submit written or electronic and regulations. comments on the SECG at any time. ADDRESSES: Submit written comments II. Comments on the SECG to the Division of Dockets Interested persons may submit to the Management (HFA–305), Food and Drug Division of Dockets Management (see Administration, 5630 Fishers Lane, rm. ADDRESSES) written or electronic 1061, Rockville, MD 20852. Submit comments regarding this SECG. Submit electronic comments on the SECG to a single copy of electronic comments or https://www.regulations.gov. Submit two paper copies of any mailed written requests for single copies of the comments, except that individuals may SECG to the Division of Dietary submit one paper copy. Comments are Supplement Programs, Office of to be identified with the docket number Nutrition, Labeling, and Dietary found in brackets in the heading of this Supplements (HFS–810), Center for document. The SECG and received Food Safety and Applied Nutrition, Food and Drug Administration, 5100 1 FDA published a correction to the final rule in Paint Branch Pkwy., College Park, MD the Federal Register of October 24, 1997 (62 FR 20740, or fax your request to 301–436– 55331). The correction was to correct a RIN number 2639. Send one self-addressed adhesive that appeared in the September 23, 1997, final rule. DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1 41364 Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Notices 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 document at https:// www.cfsan.fda.gov/guidance.html. Dated: July 10, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16448 Filed 7–17–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Refugee Resettlement Noncompetitive Urgent Single Source Unaccompanied Alien Children Trauma Initiative Division of Unaccompanied Children’s Services, Office of Refugee Resettlement, DHHS. ACTION: Notice to Award a Noncompetitive Urgent Single Source Unaccompanied Alien Children Trauma Initiative. dwashington3 on PRODPC61 with NOTICES3 AGENCY: CFDA#: 93.676. Legislative Authority: Section 462 of the Homeland Security Act of 2002 (6 U.S.C. 279), which, in March 2003, transferred responsibility for the Unaccompanied Alien Children’s Program from the Commissioner of the former Immigration and Naturalization Service (INS) to the Director of Office of Refugee Resettlement (ORR) within the Department of Health and Human Services (HHS). Amount of Award: $1,826,037.00. Project Period: July 15, 2008–January 15, 2011. Summary: Notice is hereby given that the Office of Refugee Resettlement’s Division of Unaccompanied Children’s Services (ORR/DUCS) will award a noncompetitive urgent single-source award to the Latin American Health Institute (LHI) to provide urgent care for unaccompanied alien children (UAC) in response to an unsolicited application. ORR/DUCS-funded facilities currently have very limited capacity to help UAC VerDate Aug<31>2005 15:36 Jul 17, 2008 Jkt 214001 cope with potentially devastating consequences of trauma. Such limited trauma-informed services within the ORR/DUCS network of care puts UAC and the ORR/DUCS program at tremendous risk. A great number of UAC have been subjected to severe trauma, including sexual abuse and sexual assault in their home countries or on their journey to the U.S.; gang violence; domestic violence; traumatic loss of a parent; and physical abuse and neglect. In addition, UAC experience the increased probability of ongoing trauma as a result of their uncertain legal status and return to difficult life circumstances. ORR/ DUCS-funded facilities currently have very limited specifically targeted capacity to help UAC cope with the potentially devastating consequences of trauma. Trauma affects children in very complex ways, including behavioral problems and potential involvement with the juvenile justice system; suicidal ideation and attempts; serious depression; and lasting delays in reaching emotional, cognitive, and interpersonal developmental milestones. ORR/DUCS-funded care providers are in a unique position to assist and intervene in these cases in order to minimize the harmful effects of past and possible ongoing trauma. The lack of expertise in addressing trauma leaves the ORR/DUCS-funded care provider facilities staff particularly vulnerable to the occupational hazards of working with traumatized children, such as vicarious trauma, boundary violations with children, job burnout, and high staff turnover. The youth workers in the ORR/DUCSfunded facilities do not have specific knowledge of childhood trauma and more importantly, they lack effective responses such that they are left illprepared to handle the complex needs of the UAC in their care. Without this type of expertise, staff in the facilities may in certain situations indirectly or unknowingly foster an environment that perpetuates trauma for the children. Trauma training will prepare care provider facility staff to better help UAC and to convey accurate information to their sponsors, thus creating safer outcomes for the youth and the communities where they are released. The LHI Unaccompanied Alien Children Trauma Initiative will provide specialized training in delivery of trauma-informed services, and identification of ways that promote mastery and resilience in trauma victims, based on proven expertise in child trauma and immigrant and refugee experience. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Maureen Dunn, Director, Division of Unaccompanied Children’s Services, Office of Refugee Resettlement, 900 D Street, SW., Washington, DC 20047. e-mail: Maureen.Dunn@acf.hhs.gov and phone: 202–401–5523. Dated: July 7, 2008. David H. Siegel, Acting Director, Office of Refugee Resettlement. [FR Doc. E8–16573 Filed 7–17–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2008–0178] Collection of Information Under Review by Office of Management and Budget: OMB Control Numbers: 1625– 0032, 1625–0037, 1625–0041 and 1625– 0042 Coast Guard, DHS. Thirty-day notice requesting comments. AGENCY: ACTION: SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this request for comments announces that the U.S. Coast Guard is forwarding four Information Collection Requests (ICRs), abstracted below, to the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) requesting an extension of their approval for the following collections of information: (1) 1625– 0032, Vessel Inspection Related Forms and Reporting Requirements Under Title 46 U.S. Code; (2) 1625–0037, Certificates of Compliance, Boiler/ Pressure Vessel Repairs, Cargo Gear Records, and Shipping Papers; (3) 1625– 0041, Various International Agreement Pollution Prevention Certificates and Documents, and Equivalency Certificates; and (4) 1625–0042, Requirements for Lightering of Oil and Hazardous Material Cargoes. Our ICRs describe the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties. DATES: Please submit comments on or before August 18, 2008. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2008–0178] to the Docket Management Facility (DMF) at the U.S. Department of Transportation (DOT) or to OIRA. To avoid duplication, E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 73, Number 139 (Friday, July 18, 2008)]
[Notices]
[Pages 41363-41364]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1995-N-0400 (formerly Docket No. 1995N-0245), FDA-1995-
N-0029 (formerly Docket No. 1995N-0282), FDA-1995-N-0224 (formerly 
Docket No. 1995N-0347)]


Small Entity Compliance Guide: Food Labeling; Nutrient Content 
Claims: Definition for ``High Potency'' and Definition of 
``Antioxidant'' for Use in Nutrient Content Claims for Dietary 
Supplements and Conventional Foods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide (SECG) for a final rule 
published in the Federal Register of September 23, 1997, entitled 
``Food Labeling; Nutrient Content Claims; Definition for ``High 
Potency'' and Definition of ``Antioxidant'' for Use in Nutrient Content 
Claims for Dietary Supplements and Conventional Foods.'' This SECG is 
intended to set forth in plain language the requirements of the 
regulation and to help small businesses understand the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the SECG to https://www.regulations.gov. Submit written requests for 
single copies of the SECG to the Division of Dietary Supplement 
Programs, Office of Nutrition, Labeling, and Dietary Supplements (HFS-
810), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax 
your request to 301-436-2639. Send one self-addressed adhesive label to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT:  Robert J. Moore, Center for Food 
Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2375.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 23, 1997 (62 FR 49868), FDA 
issued a final rule amending its regulations to: Define the term ``high 
potency'' as a nutrient content claim; define nutrient content claims 
using the term ``antioxidant'' (e.g., ``good source of antioxidants,'' 
``high in antioxidants,'' ``more antioxidants'') and to correct an 
omission pertaining to the use of ``sugar free'' claims on dietary 
supplements. This final rule became effective March 23, 1999.\1\
---------------------------------------------------------------------------

    \1\ FDA published a correction to the final rule in the Federal 
Register of October 24, 1997 (62 FR 55331). The correction was to 
correct a RIN number that appeared in the September 23, 1997, final 
rule.
---------------------------------------------------------------------------

    FDA examined the economic implementation of the final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and 
determined that the final rule might have a significant economic impact 
on a substantial number of small entities. In compliance with section 
212 of the Small Business Regulatory Enforcement Fairness Act (Public 
Law 104-121), FDA is making available this SECG stating in plain 
language the requirements of the regulation.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the agency's current thinking on this subject. 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 SECG. 
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 SECG and received

[[Page 41364]]

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 document at 
https://www.cfsan.fda.gov/guidance.html.

    Dated: July 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16448 Filed 7-17-08; 8:45 am]
BILLING CODE 4160-01-S

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