Submission for OMB Review; Comment Request, 7998-7999 [07-790]

Download as PDF 7998 Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices Medicare Beneficiary Database (09–70– 0530), and other payer information to be provided by the TROOP Facilitator. Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)). SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE PRIVACY ACT: None. CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORD SOURCE CATEGORIES: Summary prescription drug claim information contained in this system is obtained from the Prescription Benefit Package (PBP) Plans and Medicare Advantage (MA–PBP) Plans daily and monthly drug event transaction reports, [FR Doc. E7–2984 Filed 2–21–07; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: National Directory of New Hires. OMB No.: 0970–0166. Description: Public Law 104–193, the ‘‘Personal Responsibility and Work Number of respondents Instrument rwilkins on PROD1PC63 with NOTICES New Hire: Employers Reporting Manually ................................................... New Hire: Employers Reporting Electronically ............................................ New Hire: States .......................................................................................... Quarterly Wage & Unemployment Compensation ...................................... Multistate Employers’ Notification Form ...................................................... Estimated Total Annual Burden Hours: 760,828. Additional Information: Copies of the proposed collection may be obtained 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. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after the publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, FAX: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. VerDate Aug<31>2005 14:11 Feb 21, 2007 Jkt 211001 Number of responses per respondent 5,166,000 1,134,000 54 54 2,808 Dated: February 15, 2007. Robert Sargis, Reports Clearance Officer. [FR Doc. 07–789 Filed 2–21–07; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Needs Assessment for Promoting Cultural Competence and Diversity in Youth Mentoring Programs Toolkit. OMB No.: New Collection. Description: The Department of Health and Human Services’ (HHS) Mentoring Children of Prisoners (MCP) program, administered under the Family Youth Services Bureau (FYSB) within the Administration for Children and Families (ACF), was authorized by the Promoting Safe and Stable Families Act PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Opportunity Reconciliation Act of 1996,’’ requires the Office of Child Support Enforcement (OCSE) to operate a National Directory of New Hires (NDNH) to improve the ability of State child support enforcement agencies to locate noncustodial parents and collect child support across State lines. The law requires employers to report newly hired employees to States. States are then required to periodically transmit new hire data received from employers to the NDNH, and to transmit wage and unemployment compensation claims data to the NDNH on a quarterly basis. Federal agencies are required to report new hires and quarterly wage data directly to the NDNH. All data is transmitted to the NDNH electronically. Respondents: Employers, State Child Support Enforcement Agencies, State Workforce Agencies, Federal Agencies. Annual Burden Estimates: Average burden hours per response 3.484 33.272 83.333 8 1 .025 .00028 66.7 .033 .050 Total burden hours 449,959 10,565 300,150 14 140 of 2001 (SSFA, Pub. L. 107–133). The MCP program is designed to nurture children who have one or both parents incarcerated. The Secretary of HHS is mandated to appropriate funds for the MCP grant program, specifically for evaluation, research, training, and technical assistance. In FY 2004, grantees began submitting progress reports to HHS. FYSB will conduct an assessment of the mentoring community to identify and assess needs for the purpose of building a toolkit of practical information and tools to assist mentoring programs in promoting cultural competence and diversity of their programs. The toolkit modules address recruiting minority mentors, assessing and matching mentors and mentees, training, educating program staff and participants, and promoting ethnic identity development. Respondents: Mentoring Children of Prisoners grantees and National Mentoring Partnership (MENTOR) affiliated mentoring organizations. Annual Burden Estimates: E:\FR\FM\22FEN1.SGM 22FEN1 7999 Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices Number of respondents Instrument Mentoring ToolKit Web-based Needs Assessment Questionannaire ........... Mentoring ToolKit Web-based focus group ................................................... Mentoring ToolKit Web-based Feedback questionnaire ............................... Estimated Total Annual Burden Hours: 397 Additional Information: Copies of the proposed collection may be obtained 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. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: February 15, 2007. Robert Sargis, Reports Clearance Officer. [FR Doc. 07–790 Filed 2–21–07; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E–0252] Determination of Regulatory Review Period for Purposes of Patent Extension; LEVEMIR 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 LEVEMIR 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 VerDate Aug<31>2005 17:50 Feb 21, 2007 Jkt 211001 Number of responses per respondent Average burden hours per response 1 1 1 .75 1 .25 442 40 100 Commerce, for the extension of a patent that 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–7), 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 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 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 LEVEMIR (insulin determir (rDNA origin)). PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Total burden hours 332 40 25 LEVEMIR is indicated for once or twicedaily subcutaneous administration in the treatment of adult patients with diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for LEVEMIR (U.S. Patent No. 5,750,497) from Novo Nordisk A/S, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 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 LEVEMIR represented the first permitted commercial marketing or use of the product. 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 LEVEMIR is 2,896 days. Of this time, 1,971 days occurred during the testing phase of the regulatory review period, while 925 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) became effective: July 14, 1997. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on July 14, 1997. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: December 5, 2002. FDA has verified the applicant’s claim that the new drug application (NDA) for LEVIMIR (NDA 21–536) was initially submitted on December 5, 2002. 3. The date the application was approved: June 16, 2005. FDA has verified the applicant’s claim that NDA 21–536 was approved on June 16, 2005. 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, E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 72, Number 35 (Thursday, February 22, 2007)]
[Notices]
[Pages 7998-7999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Needs Assessment for Promoting Cultural Competence and 
Diversity in Youth Mentoring Programs Toolkit.
    OMB No.: New Collection.
    Description: The Department of Health and Human Services' (HHS) 
Mentoring Children of Prisoners (MCP) program, administered under the 
Family Youth Services Bureau (FYSB) within the Administration for 
Children and Families (ACF), was authorized by the Promoting Safe and 
Stable Families Act of 2001 (SSFA, Pub. L. 107-133). The MCP program is 
designed to nurture children who have one or both parents incarcerated. 
The Secretary of HHS is mandated to appropriate funds for the MCP grant 
program, specifically for evaluation, research, training, and technical 
assistance. In FY 2004, grantees began submitting progress reports to 
HHS.
    FYSB will conduct an assessment of the mentoring community to 
identify and assess needs for the purpose of building a toolkit of 
practical information and tools to assist mentoring programs in 
promoting cultural competence and diversity of their programs. The 
toolkit modules address recruiting minority mentors, assessing and 
matching mentors and mentees, training, educating program staff and 
participants, and promoting ethnic identity development.
    Respondents: Mentoring Children of Prisoners grantees and National 
Mentoring Partnership (MENTOR) affiliated mentoring organizations.
    Annual Burden Estimates:

[[Page 7999]]



----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Mentoring ToolKit Web-based Needs Assessment                 442               1             .75             332
 Questionannaire................................
Mentoring ToolKit Web-based focus group.........              40               1            1                 40
Mentoring ToolKit Web-based Feedback                         100               1             .25              25
 questionnaire..................................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 397
    Additional Information: Copies of the proposed collection may be 
obtained 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. All requests should be identified by the title of the 
information collection. E-mail address: infocollection@acf.hhs.gov.
    OMB Comment: OMB is required to make a decision concerning the 
collection of information between 30 and 60 days after publication of 
this document in the Federal Register. Therefore, a comment is best 
assured of having its full effect if OMB receives it within 30 days of 
publication. Written comments and recommendations for the proposed 
information collection should be sent directly to the following: Office 
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and 
Families.

    Dated: February 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07-790 Filed 2-21-07; 8:45 am]
BILLING CODE 4184-01-M