Proposed Information Collection Activity; Comment Request, 21247 [2015-08842]
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21247
Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Grants to States for Access and
Visitation
OMB No.: 0970–0204
Description: On an annual basis,
States must provide OCSE with data on
programs that the Grants to States for
Access and Visitation Program has
funded. These program reporting
requirements include, but are not
limited to, the collection of data on the
number of parents served, types of
services delivered, program outcomes,
client socio economic data, referrals
sources, and other relevant data
including the number of noncustodial
parents who were able to obtain
increased parenting time with their
children.
Respondents: State Child Access and
Visitation Programs and State and/or
local service providers.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
tkelley on DSK3SPTVN1PROD with NOTICES
Online Portal Survey by States and Jurisdictions ...........................................
Survey of local service grantees .....................................................................
Estimated Total Annual Burden
Hours: 6,160.
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: infocollection@
acf.hhs.gov. 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.
54
331
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0152]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RAVICTI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Robert Sargis,
Reports Clearance Officer.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RAVICTI and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Campus Rm. 3180,
Silver Spring, MD 20993, 301–796–
7900.
[FR Doc. 2015–08842 Filed 4–16–15; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4184–01–P
VerDate Sep<11>2014
19:08 Apr 16, 2015
Jkt 235001
SUMMARY:
The Drug
Price Competition and Patent Term
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden hours
per response
16
16
Total burden
hours
864
5,296
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product RAVICTI (glycerol
phenylbutyrate). RAVICTI is indicated
for use as a nitrogen-binding agent for
chronic management of adult and
pediatric patients 2 years of age or older
with urea cycle disorders that cannot be
managed by dietary protein restriction
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Page 21247]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08842]
[[Page 21247]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Grants to States for Access and Visitation
OMB No.: 0970-0204
Description: On an annual basis, States must provide OCSE with data
on programs that the Grants to States for Access and Visitation Program
has funded. These program reporting requirements include, but are not
limited to, the collection of data on the number of parents served,
types of services delivered, program outcomes, client socio economic
data, referrals sources, and other relevant data including the number
of noncustodial parents who were able to obtain increased parenting
time with their children.
Respondents: State Child Access and Visitation Programs and State
and/or local service providers.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Online Portal Survey by States and Jurisdictions 54 1 16 864
Survey of local service grantees................ 331 1 16 5,296
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6,160.
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: infocollection@acf.hhs.gov. 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. 2015-08842 Filed 4-16-15; 8:45 am]
BILLING CODE 4184-01-P
