81_FR_16245 81 FR 16187 - Meeting of the President's Council on Fitness, Sports, and Nutrition

81 FR 16187 - Meeting of the President's Council on Fitness, Sports, and Nutrition

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 58 (March 25, 2016)

Page Range16187-16188
FR Document2016-06810

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold its annual meeting. The meeting will be open to the public.

Federal Register, Volume 81 Issue 58 (Friday, March 25, 2016) 
[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16187-16188]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the President's Council on Fitness, Sports, and 
Nutrition

AGENCY: President's Council on Fitness, Sports, and Nutrition, Office 
of the Assistant Secretary for Health, Office of the Secretary, 
Department of Health and Human Services.

ACTION: Notice of meeting.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services (HHS) is hereby giving notice 
that the President's Council on Fitness, Sports, and Nutrition (PCFSN) 
will hold its annual meeting. The meeting will be open to the public.

DATES: The meeting will be held on May 16, 2016, from 9:00 a.m. to 
12:00 p.m.

ADDRESSES: Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Great Hall, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Ms. Shellie Pfohl, Executive Director, 
Office of the President's Council on Fitness, Sports, and Nutrition, 
Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, 
(240) 276-9567. Information about PCFSN, including details about the 
upcoming meeting, can be obtained at www.fitness.gov.

SUPPLEMENTARY INFORMATION: The primary functions of the PCFSN include 
(1) advising the President, through the Secretary, concerning progress 
made in carrying out the provisions of Executive Order 13545 and 
recommending to the President, through the Secretary, actions to 
accelerate progress; (2) advising the Secretary on ways to promote 
regular physical activity, fitness, sports

[[Page 16188]]

participation, and good nutrition. Recommendations may address, but are 
not necessarily limited to, public awareness campaigns; federal, state, 
and local physical activity; fitness, sports participation, and 
nutrition initiatives; and partnership opportunities between public- 
and private-sector health promotion entities; (3) functioning as a 
liaison to relevant state, local, and private entities in order to 
advise the Secretary regarding opportunities to extend and improve 
physical activity, fitness, sports, and nutrition programs and services 
at the local, state, and national levels; and (4) monitoring the need 
to enhance programs and educational and promotional materials 
sponsored, overseen, or disseminated by the Council, and shall advise 
the Secretary, as necessary, concerning such need. In performing its 
functions, the Council shall take into account the Federal Dietary 
Guidelines for Americans and the Physical Activity Guidelines for 
Americans.
    The PCFSN will hold, at a minimum, one meeting per fiscal year. The 
meeting will be held to (1) assess ongoing Council activities; and, (2) 
discuss and plan future projects and programs. The agenda for the 
planned meeting is being developed and will be posted at 
www.fitness.gov when it has been finalized.
    The meeting that is scheduled to be held on May 16, 2016, is open 
to the public. Every effort will be made to provide reasonable 
accommodations for persons with disabilities and/or special needs who 
wish to attend the meeting. Persons with disabilities and/or special 
needs should call (240) 276-9567 no later than close of business on May 
2, 2016, to request accommodations. Members of the public who wish to 
attend the meeting are asked to pre-register by sending an email to 
[email protected] or by calling (240) 276-9567. Registration for 
public attendance must be completed before close of business on May 9, 
2016.

    Dated: March 11, 2016.
Tasha Bradley,
Director of Communications, Office of the President's Council on 
Fitness, Sports, and Nutrition, U.S. Department of Health and Human 
Services.
[FR Doc. 2016-06810 Filed 3-24-16; 8:45 am]
 BILLING CODE 4150-35-P

Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices 16187 Docket: For access to the docket to processing, and packing of the drug are FDA intends to hold a public meeting read background documents or the adequate to assure and preserve its following the close of the comment electronic and written/paper comments identity, strength, quality, and purity; period to discuss further the evaluation received, go to http:// and that the inactive ingredients and of the abuse deterrence of generic opioid www.regulations.gov and insert the composition of the generic drug are not drug products and related issues, as docket number, found in brackets in the unsafe for use under the conditions appropriate. Further details will follow heading of this document, into the prescribed, recommended, or suggested in a notice of public meeting published ‘‘Search’’ box and follow the prompts in the labeling (see, e.g., the Federal in the Federal Register. and/or go to the Division of Dockets Food, Drug, and Cosmetic Act (the FD&C Act) 505(j)(2)(A) and (j)(4) (21 II. Electronic Access Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. U.S.C. 355(j)(2)(A) and (j)(4))). FDA Persons with access to the Internet Submit written requests for single classifies as ‘‘therapeutically may obtain the document at either copies of the draft guidance to the equivalent’’ those products that meet http://www.fda.gov/Drugs/Guidance Division of Drug Information, Center for the following general criteria: (1) They ComplianceRegulatoryInformation/ Drug Evaluation and Research, Food are approved as safe and effective; (2) Guidances/default.htm or http:// and Drug Administration, 10001 New they are pharmaceutical equivalents in www.regulations.gov. Hampshire Ave., Hillandale Building, that they: (a) Contain identical amounts Dated: March 21, 2016. 4th Floor, Silver Spring, MD 20993– of the same active ingredient in the Leslie Kux, 0002. Send one self-addressed adhesive same dosage form and route of Associate Commissioner for Policy. label to assist that office in processing administration, and (b) meet compendial or other applicable [FR Doc. 2016–06766 Filed 3–24–16; 8:45 am] your requests. See the SUPPLEMENTARY INFORMATION section for electronic standards of strength, quality, purity, BILLING CODE 4164–01–P access to the draft guidance document. and identity; (3) they are bioequivalent; FOR FURTHER INFORMATION CONTACT: Gail (4) they are adequately labeled; and (5) they are manufactured in compliance DEPARTMENT OF HEALTH AND Schmerfeld, Office of Generic Drugs, HUMAN SERVICES Center for Drug Evaluation and with current good manufacturing Research, Food and Drug practices regulations. (See preface of Meeting of the President’s Council on Administration, 10903 New Hampshire Approved Drug Products with Fitness, Sports, and Nutrition Ave., Silver Spring, MD 20993–0002, Therapeutic Equivalence Evaluations 301–796–9291, email: gail.schmerfeld@ (commonly referred to as the Orange AGENCY: President’s Council on Fitness, fda.hhs.gov. Book).) FDA believes that a product Sports, and Nutrition, Office of the classified as therapeutically equivalent Assistant Secretary for Health, Office of SUPPLEMENTARY INFORMATION: can be substituted with the full the Secretary, Department of Health and I. Background expectation that the substituted product Human Services. will produce the same clinical effect ACTION: Notice of meeting. FDA is announcing the availability of and safety profile as the reference a draft guidance for industry entitled product. SUMMARY: As stipulated by the Federal ‘‘General Principles for Evaluating the Accordingly, if the RLD’s labeling Advisory Committee Act, the U.S. Abuse Deterrence of Generic Solid Oral describes abuse-deterrent properties, the Department of Health and Human Opioid Drug Products.’’ Prescription ANDA applicant should evaluate its Services (HHS) is hereby giving notice opioid analgesics are an important product to show that it is no less abuse- that the President’s Council on Fitness, component of modern pain deterrent than the RLD with respect to Sports, and Nutrition (PCFSN) will hold management. However, abuse and all potential routes of abuse. Marketing its annual meeting. The meeting will be misuse of these drug products have a generic opioid drug product that is open to the public. created a serious and growing public less abuse-deterrent than the RLD could DATES: The meeting will be held on May health problem. One important step lead opioid abusers to preferentially 16, 2016, from 9:00 a.m. to 12:00 p.m. toward the goal of creating safer opioid seek out and abuse generics. ADDRESSES: Hubert H. Humphrey analgesics has been the development of This draft guidance describes FDA’s opioid drug products that are Building, 200 Independence Avenue current thinking about the studies that formulated to deter abuse. FDA SW., Great Hall, Washington, DC 20201. should be conducted by a potential considers the development of these ANDA applicant and submitted to FDA FOR FURTHER INFORMATION CONTACT: Ms. products a high public health priority. in an ANDA to demonstrate that a Shellie Pfohl, Executive Director, Office It is important that generic versions of generic solid oral opioid drug product is of the President’s Council on Fitness, opioids that reference listed drugs no less abuse-deterrent than its RLD Sports, and Nutrition, Tower Building, whose labeling describes abuse- with respect to all potential routes of 1101 Wootton Parkway, Suite 560, deterrent properties are available to help abuse. Rockville, MD 20852, (240) 276–9567. ensure availability of analgesics for This draft guidance is being issued Information about PCFSN, including patients who need them. consistent with FDA’s good guidance details about the upcoming meeting, can For FDA to approve an abbreviated practices regulation (21 CFR 10.115). be obtained at www.fitness.gov. new drug application (ANDA), the The draft guidance, when finalized, will SUPPLEMENTARY INFORMATION: The Agency must find, among other things, represent the current thinking of FDA primary functions of the PCFSN include asabaliauskas on DSK3SPTVN1PROD with NOTICES that the generic drug product has the on the principles for evaluating the (1) advising the President, through the same active ingredient(s), dosage form, abuse-deterrence of generic solid oral Secretary, concerning progress made in route of administration, strength, and, opioid drug products. It does not carrying out the provisions of Executive with limited exceptions, labeling as the establish any rights for any person and Order 13545 and recommending to the reference listed drug (RLD); is is not binding on FDA or the public. President, through the Secretary, actions bioequivalent to its RLD; that the You can use an alternative approach if to accelerate progress; (2) advising the methods used in, or the facilities and it satisfies the requirements of the Secretary on ways to promote regular controls used for, the manufacture, applicable statutes and regulations. physical activity, fitness, sports VerDate Sep<11>2014 18:30 Mar 24, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1

16188 Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices participation, and good nutrition. DEPARTMENT OF HEALTH AND accommodations may be required Recommendations may address, but are HUMAN SERVICES should contact Professional and not necessarily limited to, public Scientific Associates at (703) 234–1700 awareness campaigns; federal, state, and Meeting of the Advisory Committee on and reference this meeting. Requests for local physical activity; fitness, sports Minority Health special accommodations should be participation, and nutrition initiatives; made at least ten (10) business days AGENCY: Office of Minority Health, and partnership opportunities between prior to the meeting. Office of the Secretary, Department of public- and private-sector health Health and Human Services. Members of the public will have an promotion entities; (3) functioning as a opportunity to provide comments at the ACTION: Notice of meeting. liaison to relevant state, local, and meeting. Public comments will be private entities in order to advise the SUMMARY: As stipulated by the Federal limited to two minutes per speaker Secretary regarding opportunities to Advisory Committee Act, the during the time allotted. Individuals extend and improve physical activity, Department of Health and Human who would like to submit written fitness, sports, and nutrition programs Services (HHS) is hereby giving notice statements should email, mail, or fax and services at the local, state, and that the Advisory Committee on their comments to the designated Minority Health (ACMH) will hold a contact at least seven (7) business days national levels; and (4) monitoring the meeting conducted as a telephone prior to the meeting. need to enhance programs and educational and promotional materials conference call. This call will be open Any members of the public who wish to the public. Preregistration is required to have electronic or printed material sponsored, overseen, or disseminated by for both public participation and distributed to ACMH members should the Council, and shall advise the comment. Any individual who wishes email OMH-ACMH@hhs.gov or mail Secretary, as necessary, concerning such to participate in the call should email their materials to the Designated Federal need. In performing its functions, the Officer, ACMH, Tower Building, 1101 OMH-ACMH@hhs.gov by April 12, Council shall take into account the Wootton Parkway, Suite 600, Rockville, 2016. Instructions regarding Federal Dietary Guidelines for Maryland 20852, prior to close of participating in the call and how to Americans and the Physical Activity provide verbal public comments will be business on April 8, 2016. Guidelines for Americans. given at the time of preregistration. Dated: March 2, 2016. The PCFSN will hold, at a minimum, Information about the meeting is Minh Wendt, one meeting per fiscal year. The meeting available from the designated contact Designated Federal Officer, Office of Minority will be held to (1) assess ongoing and will be posted on the Web site for Health, U.S. Department of Health and Council activities; and, (2) discuss and the Office of Minority Health (OMH), Human Services. plan future projects and programs. The www.minorityhealth.hhs.gov. [FR Doc. 2016–06809 Filed 3–24–16; 8:45 am] agenda for the planned meeting is being Information about ACMH activities can BILLING CODE 4150–29–P developed and will be posted at be found on the OMH Web site under www.fitness.gov when it has been the heading About OMH. finalized. DATES: The conference call will be held DEPARTMENT OF HEALTH AND The meeting that is scheduled to be on April 14, 2016, 11:00 a.m.–1:00 p.m. HUMAN SERVICES held on May 16, 2016, is open to the ET ADDRESSES: Instructions regarding Final Effect of Designation of a Class public. Every effort will be made to of Employees for Addition to the provide reasonable accommodations for participating in the call will be given at the time of preregistration. Special Exposure Cohort persons with disabilities and/or special needs who wish to attend the meeting. FOR FURTHER INFORMATION CONTACT: Dr. AGENCY: National Institute for Persons with disabilities and/or special Minh Wendt, Designated Federal Occupational Safety and Health needs should call (240) 276–9567 no Officer, ACMH, Tower Building, 1101 (NIOSH), Centers for Disease Control later than close of business on May 2, Wootton Parkway, Suite 600, Rockville, and Prevention, Department of Health 2016, to request accommodations. Maryland 20852. Phone: 240–453–8222; and Human Services (HHS). Members of the public who wish to fax: 240–453–8223; email OMH-ACMH@ ACTION: Notice. attend the meeting are asked to pre- hhs.gov. register by sending an email to SUPPLEMENTARY INFORMATION: In SUMMARY: HHS gives notice concerning rsvp.fitness@hhs.gov or by calling (240) accordance with Public Law 105–392, the final effect of the HHS decision to 276–9567. Registration for public the ACMH was established to provide designate a class of employees from the attendance must be completed before advice to the Deputy Assistant Secretary Battelle Laboratories-King Avenue in close of business on May 9, 2016. for Minority Health on improving the Columbus, Ohio, as an addition to the health of each racial and ethnic Special Exposure Cohort (SEC) under Dated: March 11, 2016. minority group and on the development the Energy Employees Occupational Tasha Bradley, of goals and specific program activities Illness Compensation Program Act of Director of Communications, Office of the of the OMH. 2000. President’s Council on Fitness, Sports, and Topics to be discussed during this conference call include planning for FOR FURTHER INFORMATION CONTACT: asabaliauskas on DSK3SPTVN1PROD with NOTICES Nutrition, U.S. Department of Health and Human Services. upcoming in-person meetings and Stuart L. Hinnefeld, Director, Division [FR Doc. 2016–06810 Filed 3–24–16; 8:45 am] finalizing the charge and the formation of Compensation Analysis and Support, of the data workgroup. NIOSH, 1090 Tusculum Avenue, MS C– BILLING CODE 4150–35–P This call will be limited to 125 46, Cincinnati, OH 45226–1938, participants. The OMH will make every Telephone 877–222–7570. Information effort to accommodate persons with requests can also be submitted by email special needs. Individuals who have to DCAS@CDC.GOV. special needs for which special SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:30 Mar 24, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1


Document Created: 2018-02-02 15:18:21
Document Modified: 2018-02-02 15:18:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of meeting.
DatesThe meeting will be held on May 16, 2016, from 9:00 a.m. to 12:00 p.m.
ContactMs. Shellie Pfohl, Executive Director, Office of the President's Council on Fitness, Sports, and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276-9567. Information about PCFSN, including details about the upcoming meeting, can be obtained at www.fitness.gov.
FR Citation81 FR 16187 
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