Proposed Information Collection Activity; Comment Request, 21247 [2015-08842]

Download as PDF 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 http:// 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 http://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