Small Entity Compliance Guide: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis; Availability, 22942-22943 [E9-11320]

Download as PDF 22942 Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Notices Dated: May 8, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–11317 Filed 5–14–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0191] Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the Food Advisory Committee. This advisory committee is under the purview of the Center for Food Safety and Applied Nutrition (CFSAN). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, encourages nominations of qualified candidates from these groups. DATES: Nominations will be accepted for those voting consumer representative vacancies that will occur on June 30, 2010. Nominations received before July 14, 2009, will be considered for June 30, 2010, vacancies. Nominations received after July 14, 2009, will be accepted for vacancies occurring after June 30, 2010. ADDRESSES: All nominations for membership should be sent electronically to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight and Management Staff (HF– 4), 5600 Fishers Lane, rm. 15A–12, Rockville, MD 20857. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site at https:// www.fda.gov/oc/advisory/default.htm. FOR FURTHER INFORMATION CONTACT: Carolyn Jeletic, Center for Food Safety and Applied Nutrition (HFS–024), 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1913, FAX: 301–436– 2637, e-mail: Carolyn.Jeletic@fda.hhs.gov. FDA is requesting nominations for voting consumer members on the following CFSAN committee: SUPPLEMENTARY INFORMATION: VerDate Nov<24>2008 16:43 May 14, 2009 Jkt 217001 I. Function Food Advisory Committee The Committee provides advice primarily to Commissioner of Food and Drugs and other appropriate officials, on emerging food safety, food science, nutrition, and other food-related health issues that FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to the following topics: (1) Broad scientific and technical food or cosmetic related issues, (2) the safety of new foods and food ingredients, (3) labeling of foods and cosmetics, (4) nutrient needs and nutritional adequacy, and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. II. Criteria for Members Persons who are nominated for membership on the committees as consumer representatives must meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze scientific and technical data, (3) understand research design, and (4) discuss benefits and risks. The consumer representative must be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. III. Selection Procedures The selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and consumer advocacy groups. The organizations have the responsibility of recommending candidates of the agency’s selection. IV. Nomination Procedures All nominations must include a cover letter, a curriculum vitae or resume (that includes the nominee’s office address, telephone number, and e-mail address), and a list of consumer or communitybased organizations for which the candidate can demonstrate active participation. Nominations will specify PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 the advisory committee for which the nominee is recommended. Nominations will include confirmation that the nominee is aware of the nomination. Any interested person or organization may nominate one or more qualified persons for membership on one or more of the advisory committees to represent consumer interests. Self-nominations are also accepted. FDA will ask the potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of a conflict of interest. The nomination should specify the committee of interest. The term of office is up to 4 years, depending on the appointment date. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: May 7, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–11319 Filed 5–14–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0209] Small Entity Compliance Guide: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis— Small Entity Compliance Guide.’’ The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of September 29, 2008, as corrected on November 12, 2008, and it is intended to set forth in plain language the legal 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 E:\FR\FM\15MYN1.SGM 15MYN1 Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Notices https://www.regulations.gov. Submit written requests for single copies of the SECG to the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 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: Blakeley Denkinger, Center for Food Safety and Applied Nutrition (HFS– 830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1450. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 29, 2008 (73 FR 56477), as corrected on November 12, 2008 (73 FR 66754), FDA issued a final rule amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis (21 CFR 101.72). The amendments allow for a health claim to be made for calcium and vitamin D and osteoporosis, and eliminate several requirements of the health claim. This final rule becomes effective January 1, 2010. FDA examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5. U.S.C. 601–612) and determined that the final rule will not 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 (Pub. L. 104–121), FDA is making available this SECG stating in plain language the legal requirements of the September 29, 2008, final rule, as corrected on November 12, 2008, concerning calcium and osteoporosis, and calcium, vitamin D, and osteoporosis. FDA is issuing this SECG as a level 2 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents FDA’s current thinking on this topic. 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 VerDate Nov<24>2008 16:43 May 14, 2009 Jkt 217001 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 comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.cfsan.fda.gov/guidance.html. Dated: May 8, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–11320 Filed 5–14–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5280–N–18] Federal Property Suitable as Facilities To Assist the Homeless AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. SUMMARY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 708–1234; TTY number for the hearing- and speechimpaired (202) 708–2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800–927–7588. SUPPLEMENTARY INFORMATION: In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 22943 published in order to comply with the December 12, 1988 Court Order in National Coalition for the Homeless v. Veterans Administration, No. 88–2503– OG (D.D.C.). Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/ unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency’s needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless. Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for ‘‘off-site use only’’ recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Theresa Rita, Division of Property Management, Program Support Center, HHS, room 5B–17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443–2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581. For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/ available or suitable/unavailable. For properties listed as suitable/ unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available. Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[Federal Register Volume 74, Number 93 (Friday, May 15, 2009)]
[Notices]
[Pages 22942-22943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11320]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0209]


Small Entity Compliance Guide: Health Claims; Calcium and 
Osteoporosis, and Calcium, Vitamin D, and Osteoporosis; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Food Labeling: 
Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and 
Osteoporosis--Small Entity Compliance Guide.'' The small entity 
compliance guide (SECG) is being issued for a final rule published in 
the Federal Register of September 29, 2008, as corrected on November 
12, 2008, and it is intended to set forth in plain language the legal 
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

[[Page 22943]]

https://www.regulations.gov. Submit written requests for single copies 
of the SECG to the Office of Nutrition, Labeling, and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740. 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: Blakeley Denkinger, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 29, 2008 (73 FR 56477), as 
corrected on November 12, 2008 (73 FR 66754), FDA issued a final rule 
amending its labeling regulation authorizing a health claim on the 
relationship between calcium and a reduced risk of osteoporosis (21 CFR 
101.72). The amendments allow for a health claim to be made for calcium 
and vitamin D and osteoporosis, and eliminate several requirements of 
the health claim. This final rule becomes effective January 1, 2010.
    FDA examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act (5. U.S.C. 601-612) and 
determined that the final rule will not 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 
(Pub. L. 104-121), FDA is making available this SECG stating in plain 
language the legal requirements of the September 29, 2008, final rule, 
as corrected on November 12, 2008, concerning calcium and osteoporosis, 
and calcium, vitamin D, and osteoporosis.
    FDA is issuing this SECG as a level 2 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The 
SECG represents FDA's current thinking on this topic. 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 comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.cfsan.fda.gov/guidance.html.

    Dated: May 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11320 Filed 5-14-09; 8:45 am]
BILLING CODE 4160-01-S

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