80 FR 20226 - Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting Requirements for the Older American Act Title VI Grant Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living

Federal Register Volume 80, Issue 72 (April 15, 2015)

Page Range		20226-20227
FR Document		2015-08654

The Administration on Aging Office (AoA), within the Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed extension of an existing collection of information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Performance Reports for Title VI grants.

Federal Register, Volume 80 Issue 72 (Wednesday, April 15, 2015)

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20226-20227]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Annual Reporting Requirements for the Older American 
Act Title VI Grant Program

AGENCY: Administration for Community Living, HHS.

ACTION: Notice.

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SUMMARY: The Administration on Aging Office (AoA), within the 
Administration for Community Living (ACL) is announcing an opportunity 
for public comment on the proposed extension of an existing collection 
of information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements relating to Performance Reports for Title VI grants.

DATES: Submit written or electronic comments on the collection of 
information by June 15, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to: [email protected]. Submit written comments on the 
collection of information to Cynthia Lacounte, ACL/Administration on 
Aging, Washington, DC 20201 or by fax at (202-357-3560).

FOR FURTHER INFORMATION CONTACT: Margaret Graves at (202) 357-3502 or 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency request or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, ACL/AoA is publishing notice of the proposed 
collection of information set forth in this document. With respect to 
the following collection of information, ACL/AoA invites comments on: 
(1) Whether the proposed collection of information is necessary for the 
proper performance of ACL/AoA's functions, including whether the 
information will have practical utility; (2) the accuracy of ACL/AoA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques when appropriate, and other forms of information 
technology. ACL/AoA estimates the burden of this collection of 
information as follows: Annual submission of the Program Performance 
Reports are due 90 days after the end of the budget period and final 
project period.
    Respondents: Federally Recognized Tribes, Tribal and Native 
Hawaiian Organizations receiving grants under Title VI, Part A, Grants 
for Native Americans; Title VI, Part B, Native Hawaiian Program and 
Title VI, Part C, Native American Caregiver Support Program.
    Estimated Number of Responses: 266.
    Total Estimated Burden Hours: 731.5.


[[Page 20227]]


    Dated: April 9, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for Aging.
[FR Doc. 2015-08654 Filed 4-14-15; 8:45 am]
 BILLING CODE 4154-01-P

Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20227

Dated: April 9, 2015. for determining the amount of extension claim that the new drug application
Kathy Greenlee, an applicant may receive. (NDA) for AUBAGIO (NDA 202992) was
Administrator and Assistant Secretary for A regulatory review period consists of submitted on August 12, 2011.
Aging. two periods of time: A testing phase and
3. The date the application was
[FR Doc. 2015–08654 Filed 4–14–15; 8:45 am] an approval phase. For human drug
products, the testing phase begins when approved: September 12, 2012. FDA has
BILLING CODE 4154–01–P verified the applicant’s claim that NDA
the exemption to permit the clinical
investigations of the drug becomes 202992 was approved on September 12,
effective and runs until the approval 2012.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES phase begins. The approval phase starts This determination of the regulatory
with the initial submission of an review period establishes the maximum
Food and Drug Administration application to market the human drug potential length of a patent extension.
product and continues until FDA grants However, the USPTO applies several
[Docket No. FDA–2013–E–0688] permission to market the drug product. statutory limitations in its calculations
Although only a portion of a regulatory of the actual period for patent extension.
Determination of Regulatory Review review period may count toward the In its application for patent extension,
Period for Purposes of Patent actual amount of extension that the this applicant seeks 5 years of patent
Extension; AUBAGIO—Patent No. Director of USPTO may award (for term extension.
5,679,709 example, half the testing phase must be
subtracted as well as any time that may Anyone with knowledge that any of
AGENCY: Food and Drug Administration, have occurred before the patent was the dates as published are incorrect may
HHS. issued), FDA’s determination of the submit to the Division of Dockets
ACTION: Notice. length of a regulatory review period for Management (see ADDRESSES) either
a human drug product will include all electronic or written comments and ask
SUMMARY: The Food and Drug of the testing phase and approval phase for a redetermination by June 15, 2015.
Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B). Furthermore, any interested person may
the regulatory review period for FDA has approved for marketing the petition FDA for a determination
AUBAGIO and is publishing this notice human drug product AUBAGIO regarding whether the applicant for
of that determination as required by (teriflunomide). AUBAGIO is indicated extension acted with due diligence
law. FDA has made the determination for treatment of patients with relapsing during the regulatory review period by
because of the submission of an forms of multiple sclerosis. Subsequent
application to the Director of the U.S. October 13, 2015. To meet its burden,
to this approval, the USPTO received a
Patent and Trademark Office (USPTO), the petition must contain sufficient facts
patent term restoration application for
Department of Commerce, for the to merit an FDA investigation. (See H.
AUBAGIO (U.S. Patent No. 5,679,709)
extension of a patent which claims that from sanofi-aventis Deutschland GMBH, Rept. 857, part 1, 98th Cong., 2d sess.,
human drug product. and the USPTO requested FDA’s pp. 41–42, 1984.) Petitions should be in
ADDRESSES: Submit electronic assistance in determining this patent’s the format specified in 21 CFR 10.30.
comments to http:// eligibility for patent term restoration. In Interested persons may submit to the
www.regulations.gov. Submit written a letter dated January 31, 2014, FDA Division of Dockets Management (see
petitions (two copies are required) and advised the USPTO that this human ADDRESSES) electronic or written
written comments to the Division of drug product had undergone a comments and written or electronic
Dockets Management (HFA–305), Food regulatory review period and that the petitions. It is only necessary to send
and Drug Administration, 5630 Fishers approval of AUBAGIO represented the one set of comments. Identify comments
Lane, Rm. 1061, Rockville, MD 20852. first permitted commercial marketing or with the docket number found in
Submit petitions electronically to http:// use of the product. Thereafter, the brackets in the heading of this
www.regulations.gov at Docket No. USPTO requested that FDA determine document. If you submit a written
FDA–2013–S–0610. the product’s regulatory review period. petition, two copies are required. A
FOR FURTHER INFORMATION CONTACT:
FDA has determined that the
petition submitted electronically must
Beverly Friedman, Office of applicable regulatory review period for
AUBAGIO is 2,940 days. Of this time, be submitted to http://
Management, Food and Drug www.regulations.gov, Docket No. FDA–
Administration, 10001 New Hampshire 2,542 days occurred during the testing
phase of the regulatory review period, 2013–S–0610.
Ave., Hillandale Campus Rm. 3180,
while 398 days occurred during the Comments and petitions that have not
Silver Spring, MD 20993, 301–796–
7900. approval phase. These periods of time been made publicly available on http://
were derived from the following dates: www.regulations.gov may be viewed in
SUPPLEMENTARY INFORMATION: The Drug 1. The date an exemption under the Division of Dockets Management
Price Competition and Patent Term section 505(i) of the Federal Food, Drug, between 9 a.m. and 4 p.m., Monday
Restoration Act of 1984 (Pub. L. 98–417) and Cosmetic Act (the FD&C Act) (21 through Friday.
and the Generic Animal Drug and Patent U.S.C. 355(i)) became effective: August
Term Restoration Act (Pub. L. 100–670) 27, 2004. FDA has verified the Dated: April 8, 2015.
generally provide that a patent may be applicant’s claim that the date the Leslie Kux,
extended for a period of up to 5 years investigational new drug application Associate Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES

so long as the patented item (human became effective was on August 27, [FR Doc. 2015–08615 Filed 4–14–15; 8:45 am]
drug product, animal drug product, 2004. BILLING CODE 4164–01–P
medical device, food additive, or color 2. The date the application was
additive) was subject to regulatory initially submitted with respect to the
review by FDA before the item was human drug product under section
marketed. Under these acts, a product’s 505(b) of the FD&C Act: August 12,
regulatory review period forms the basis 2011. FDA has verified the applicant’s

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Document Created: 2015-12-18 11:13:05
Document Modified: 2015-12-18 11:13:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit written or electronic comments on the collection of information by June 15, 2015.
Contact		Margaret Graves at (202) 357-3502 or [email protected]
FR Citation		80 FR 20226

80 FR 20226 - Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting Requirements for the Older American Act Title VI Grant Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Community Living

Federal Register Volume 80, Issue 72 (April 15, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living