Proposed Information Collection Activity; Comment Request, 55798-55799 [06-8110]

Download as PDF 55798 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Notices ESTIMATED ANNUALIZED BURDEN HOURS BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: DHHS/ACF/ASPE/DOL Enhanced Services for the Hard-toEmploy Demonstration and Evaluation: Rhode Island 15-Month Survey Amendment. OMB No. 0970–0276. Description: The Enhanced Services for the Hard-to-Employe Demonstration and Evaluation Project (HtE) seeks to learn what works in this area to date and is explicitly designed to build on past research by rigorously testing a wide variety of approaches to promote employment and improve family functioning and child well-being. The 1 1 10/60 1.10 5,180 4,300 3,000 4,000 HtE project is designed to help Temporary Assistance for Needy Families (TANF) recipients, former TANF recipients, or low-income parents who are hard-to-employ. The project is sponsored by the Office of Planning, Research and Evaluation (OPRE) of the Administration for Children and Families (ACF), the Office of the Assistant Secretary for Planning and Evaluation (ASPE) in the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Labor (DOL). The evaluation involves an experimental, random assignment design in four sites, testing a diverse set of strategies to promote employment for low-income parents who face serious obstacles to employment. The four include: (1) Intensive care management to facilitate the use of evidence-based treatment for major depression among parents receiving Medicaid in Rhode Island; (2) job readiness training, worksite placements, job coaching, job development and other training opportunities for recent parolees in New York City; (3) pre-employment services and transitional employment for longterm TANF participants in Philadelphia; and (4) home- and center-based care, enhanced with self-sufficiency services, Number of responses per respondent 13,333 300 1. Screening interview only ......................................................................................................... 2. Screener, family, and sample person interviews only ............................................................ 3. Screener, family, and sample person interviews and MEC examination (including pilot studies) ..................................................................................................................................... 4. Second dietary recall interview ............................................................................................... 5. Telephone Interview (FCBS) ................................................................................................... 6. Follow-up, special studies, and tests of procedures ............................................................... Dated: September 19, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 06–8164 Filed 9–22–06; 8:45 am] Average burden per response (hours) Number of respondents per year Burden category 1 1 1 1 5.9 30/60 20/60 5.9 for low-income families who have young children or are expecting in Kansas and Missouri. Materials for follow-up surveys for each of these sites were previously submitted to OMB and were approved. The purpose of this submission is to add physiological measures to the follow-up effort to the Rhode Island study. Respondents: The respondents to this component of the Rhode Island followup survey will be low-income parents and their children from the Rhode Island site currently participating in the HtE Project. As described in the prior OMB submission, these parents are Medicaid recipients between the ages of 18 and 45 receiving Medicaid through the managed care provider United Behavioral Health (UBH) in Rhode Island who meet study criteria with regard to their risk for depression. Children are the biological, adopted, and step-children of these parents, between the ages of 1 and 18 years of age. The annual burden estimates are detailed below, and the substantive content of each component will be detailed in the supporting statement attached to the forthcoming 30-day notice. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response 400 160 242 8 8 8 5 minutes or .08 hrs .............. 5 minutes or .08 hrs .............. 5 minutes or .08 hrs .............. rwilkins on PROD1PC63 with NOTICES RI 15-month, parent physiological component ....................... RI 15-month young child physiological component ................ RI 15-month youth physiological component .......................... Estimated Total Annual Burden Hours: 534.65. In compliance with the requirements of Section 3506(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. VerDate Aug<31>2005 17:46 Sep 22, 2006 Jkt 208001 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 Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 Total burden hours 266.66 106.66 161.33 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 E:\FR\FM\25SEN1.SGM 25SEN1 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Notices 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. Dated: September 19, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06–8110 Filed 9–22–06; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E–0031] Determination of Regulatory Review Period for Purposes of Patent Extension; CLOLAR AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for CLOLAR 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 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 VerDate Aug<31>2005 17:46 Sep 22, 2006 Jkt 208001 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 human drug product 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 Patents and Trademarks 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 recently approved for marketing the human drug product CLOLAR (clofarabine). CLOLAR is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CLOLAR (U.S. Patent No. 5,661,136) from Southern Research Institute, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 24, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of CLOLAR represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for CLOLAR is 2,200 days. Of this time, 1,926 days occurred during the testing phase of the regulatory review period, while 274 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: December 22, 1998. The applicant claims February 10, PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 55799 1999, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 22, 1998, the date FDA removed the clinical hold on the application. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: March 30, 2004. The applicant claims September 26, 2003, as the date the new drug application (NDA) for CLOLAR (NDA 21–673) was initially submitted. However, FDA records indicate that NDA 21–673 was submitted in its entirety on March 30, 2004. 3. The date the application was approved: December 28, 2004. FDA has verified the applicant’s claim that NDA 21–673 was approved on December 28, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,303 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by November 24, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 26, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 1, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 06–8115 Filed 9–22–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 71, Number 185 (Monday, September 25, 2006)]
[Notices]
[Pages 55798-55799]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: DHHS/ACF/ASPE/DOL Enhanced Services for the Hard-to-Employ 
Demonstration and Evaluation: Rhode Island 15-Month Survey Amendment.
    OMB No. 0970-0276.
    Description: The Enhanced Services for the Hard-to-Employe 
Demonstration and Evaluation Project (HtE) seeks to learn what works in 
this area to date and is explicitly designed to build on past research 
by rigorously testing a wide variety of approaches to promote 
employment and improve family functioning and child well-being. The HtE 
project is designed to help Temporary Assistance for Needy Families 
(TANF) recipients, former TANF recipients, or low-income parents who 
are hard-to-employ. The project is sponsored by the Office of Planning, 
Research and Evaluation (OPRE) of the Administration for Children and 
Families (ACF), the Office of the Assistant Secretary for Planning and 
Evaluation (ASPE) in the U.S. Department of Health and Human Services 
(HHS), and the U.S. Department of Labor (DOL).
    The evaluation involves an experimental, random assignment design 
in four sites, testing a diverse set of strategies to promote 
employment for low-income parents who face serious obstacles to 
employment. The four include: (1) Intensive care management to 
facilitate the use of evidence-based treatment for major depression 
among parents receiving Medicaid in Rhode Island; (2) job readiness 
training, worksite placements, job coaching, job development and other 
training opportunities for recent parolees in New York City; (3) pre-
employment services and transitional employment for long-term TANF 
participants in Philadelphia; and (4) home- and center-based care, 
enhanced with self-sufficiency services, for low-income families who 
have young children or are expecting in Kansas and Missouri.
    Materials for follow-up surveys for each of these sites were 
previously submitted to OMB and were approved. The purpose of this 
submission is to add physiological measures to the follow-up effort to 
the Rhode Island study.
    Respondents: The respondents to this component of the Rhode Island 
follow-up survey will be low-income parents and their children from the 
Rhode Island site currently participating in the HtE Project. As 
described in the prior OMB submission, these parents are Medicaid 
recipients between the ages of 18 and 45 receiving Medicaid through the 
managed care provider United Behavioral Health (UBH) in Rhode Island 
who meet study criteria with regard to their risk for depression. 
Children are the biological, adopted, and step-children of these 
parents, between the ages of 1 and 18 years of age.
    The annual burden estimates are detailed below, and the substantive 
content of each component will be detailed in the supporting statement 
attached to the forthcoming 30-day notice.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                            Number of
               Instrument                   Number of     responses per    Average burden hours    Total burden
                                           respondents     respondent          per response            hours
----------------------------------------------------------------------------------------------------------------
RI 15-month, parent physiological                   400               8  5 minutes or .08 hrs...          266.66
 component.
RI 15-month young child physiological               160               8  5 minutes or .08 hrs...          106.66
 component.
RI 15-month youth physiological                     242               8  5 minutes or .08 hrs...          161.33
 component.
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 534.65.
    In compliance with the requirements of Section 3506(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 
Administration, Office of Information Services, 370 L'Enfant Promenade, 
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail 
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

[[Page 55799]]

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.

    Dated: September 19, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06-8110 Filed 9-22-06; 8:45 am]
BILLING CODE 4184-01-M