80 FR 26267 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26267-26268
FR Document		2015-10987

Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26267-26268]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: Child Care and Development Fund Annual Aggregate Report--
ACF-800.
    OMB No.: 0970-0150.
    Description: Section 658K of the Child Care and Development Block 
Grant (CCDBG) Act (42 U.S.C. 9858, as amended by Pub. L. 113-186) 
requires that States and Territories submit annual aggregate data on 
the children and families receiving direct services under the Child 
Care and Development Fund. The implementing regulations for the 
statutorily required reporting are at 45 CFR 98.70 and 98.71. Annual 
aggregate reports include data elements represented in the ACF-800 
reflecting the scope, type, and methods of child care delivery. This 
provides ACF with the information necessary to make reports to 
Congress, address national child care needs, offer technical assistance 
to grantees, meet performance measures, and conduct research.
    Consistent with the recent reauthorization of the CCDBG statute, 
ACF requests extension and revision of the ACF-800 including a number 
of changes and clarifications to the reporting requirements and 
instructions. Most notably, section 658K(a)(2)(F) of the CCDBG Act now 
requires States to report the number of fatalities occurring among 
children while in the care and facility of child care providers serving 
CCDF children.
    Respondents: States, the District of Columbia, and Territories 
including Puerto Rico, Guam, the Virgin Islands, American Samoa, and 
the Northern Marianna Islands.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ACF-800.....................................              56                1               42            2,352
----------------------------------------------------------------------------------------------------------------


[[Page 26268]]

    Estimated Total Annual Burden Hours: 2,352.
    In compliance with the requirements of Section 506(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 
Planning, Research and Evaluation, 370 L'Enfant Promenade SW., 
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email 
address: [email protected]. 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, 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.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-10987 Filed 5-6-15; 8:45 am]
 BILLING CODE 4184-01-P

26268 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

Estimated Total Annual Burden determination because of the cataract surgery for the reduction of
Hours: 2,352. submission of an application to the intraocular pressure in adult patients
In compliance with the requirements Director of the U.S. Patent and with mild to moderate open-angle
of Section 506(c)(2)(A) of the Paperwork Trademark Office (USPTO), Department glaucoma currently treated with ocular
Reduction Act of 1995, the of Commerce, for the extension of a hypotensive medication. Subsequent to
Administration for Children and patent which claims that medical this approval, the USPTO received a
Families is soliciting public comment device. patent term restoration application for
on the specific aspects of the ADDRESSES: Submit electronic the ISTENT TRABECULAR MICRO-
information collection described above. comments to http:// BYPASS STENT (U.S. Patent No.
Copies of the proposed collection of www.regulations.gov. Submit written 6,626,858) from Glaukos Corporation,
information can be obtained and petitions (two copies are required) and and the USPTO requested FDA’s
comments may be forwarded by writing written comments to the Division of assistance in determining this patent’s
to the Administration for Children and Dockets Management (HFA–305), Food eligibility for patent term restoration. In
Families, Office of Planning, Research and Drug Administration, 5630 Fishers a letter dated January 30, 2014, FDA
and Evaluation, 370 L’Enfant Lane, Rm. 1061, Rockville, MD 20852. advised the USPTO that this medical
Promenade SW., Washington, DC 20447, Submit petitions electronically to device had undergone a regulatory
Attn: ACF Reports Clearance Officer. http://www.regulations.gov at Docket review period and that the approval of
Email address: infocollection@ No. FDA–2013–S–0610. the ISTENT TRABECULAR MICRO-
acf.hhs.gov. All requests should be FOR FURTHER INFORMATION CONTACT: BYPASS STENT represented the first
identified by the title of the information Beverly Friedman, Office of permitted commercial marketing or use
collection. Management, Food and Drug of the product. Thereafter, the USPTO
The Department specifically requests Administration, 10001 New Hampshire requested that FDA determine the
comments on: (a) Whether the proposed Ave., Hillandale Campus, Rm. 3180, product’s regulatory review period.
collection of information is necessary Silver Spring, MD 20993, 301–796– FDA has determined that the
for the proper performance of the 7900. applicable regulatory review period for
functions of the agency, including the ISTENT TRABECULAR MICRO-
SUPPLEMENTARY INFORMATION: The Drug
whether the information shall have BYPASS STENT is 2,820 days. Of this
Price Competition and Patent Term
practical utility; (b) the accuracy of the time, 1,535 days occurred during the
Restoration Act of 1984 (Pub. L. 98–417)
agency’s estimate of the burden of the testing phase of the regulatory review
and the Generic Animal Drug and Patent
proposed collection of information; (c) period, while 1,285 days occurred
Term Restoration Act (Pub. L. 100–670)
the quality, utility, and clarity of the during the approval phase. These
generally provide that a patent may be
information to be collected; and (d) periods of time were derived from the
extended for a period of up to 5 years
ways to minimize the burden of the following dates:
so long as the patented item (human
collection of information on 1. The date an exemption under
drug product, animal drug product,
respondents, including through the use section 520(g) of the Federal Food, Drug,
medical device, food additive, or color
of automated collection techniques or additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21
other forms of information technology. review by FDA before the item was U.S.C. 360j(g)) involving this device
Consideration will be given to marketed. Under these acts, a product’s became effective: October 7, 2004. FDA
comments and suggestions submitted regulatory review period forms the basis has verified the applicant’s claim that
within 60 days of this publication. for determining the amount of extension the date the investigational device
Robert Sargis, an applicant may receive. exemption (IDE) required under section
A regulatory review period consists of 520(g) of the FD&C Act for human tests
Reports Clearance Officer.
two periods of time: A testing phase and to begin became effective October 7,
[FR Doc. 2015–10987 Filed 5–6–15; 8:45 am]
an approval phase. For medical devices, 2004.
BILLING CODE 4184–01–P
the testing phase begins with a clinical 2. The date an application was
investigation of the device and runs initially submitted with respect to the
until the approval phase begins. The device under section 515 of the FD&C
DEPARTMENT OF HEALTH AND
approval phase starts with the initial Act (21 U.S.C. 360e): December 19,
HUMAN SERVICES
submission of an application to market 2008. FDA has verified the applicant’s
Food and Drug Administration the device and continues until claim that the premarket approval
permission to market the device is application (PMA) for the ISTENT
[Docket No. FDA–2013–E–0397] TRABECULAR MICRO-BYPASS STENT
granted. Although only a portion of a
regulatory review period may count (PMA P080030) was initially submitted
Determination of Regulatory Review December 19, 2008.
Period for Purposes of Patent toward the actual amount of extension
that the Director of USPTO may award 3. The date the application was
Extension; ISTENT TRABECULAR
(half the testing phase must be approved: June 25, 2012. FDA has
MICRO-BYPASS STENT
subtracted as well as any time that may verified the applicant’s claim that PMA
AGENCY: Food and Drug Administration, have occurred before the patent was P080030 was approved on June 25,
HHS. issued), FDA’s determination of the 2012.
ACTION: Notice. length of a regulatory review period for This determination of the regulatory
mstockstill on DSK4VPTVN1PROD with NOTICES

a medical device will include all of the review period establishes the maximum
SUMMARY: The Food and Drug testing phase and approval phase as potential length of a patent extension.
Administration (FDA) has determined specified in 35 U.S.C. 156(g)(3)(B). However, the USPTO applies several
the regulatory review period for the FDA has approved for marketing the statutory limitations in its calculations
ISTENT TRABECULAR MICRO- medical device ISTENT TRABECULAR of the actual period for patent extension.
BYPASS STENT and is publishing this MICRO-BYPASS STENT. ISTENT In its application for patent extension,
notice of that determination as required TRABECULAR MICRO-BYPASS STENT this applicant seeks 5 years of patent
by law. FDA has made the is indicated for use in conjunction with term extension.

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Document Created: 2015-12-16 07:49:46
Document Modified: 2015-12-16 07:49:46

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
FR Citation		80 FR 26267

80 FR 26267 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families