Proposed Information Collection Activity; Comment Request Proposed Projects, 45453-45454 [E8-17721]

Download as PDF 45453 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices the order. In addition, the order enables the Commission to seek civil penalties against Respondent for non-compliance with the order. The proposed Consent Agreement further requires McCormick to maintain the viability of the assets identified for divestiture. Among other requirements related to maintaining operations of the assets, the proposed Consent Agreement requires McCormick to: (1) maintain the viability, competitiveness, and marketability of the assets to be divested; (2) not cause the wasting or deterioration of the assets to be divested; (3) not sell, transfer, encumber, or otherwise impair the assets’ marketability or viability; (4) maintain the assets consistent with past practices; (5) use best efforts to preserve the assets’ existing relationships with suppliers, customers, and employees; and (6) keep and maintain the assets at inventory levels consistent with past practices. The proposed Consent Agreement prohibits McCormick, for ten (10) years, from acquiring, without providing the Commission with prior notice, any other seasoned salt product, or any interest in any other spice blends business. The provisions regarding prior notice are consistent with prior Orders. The proposed Consent Agreement does not restrict McCormick from expanding its line of spices. McCormick is required to file compliance reports with the Commission, the first of which is due within thirty (30) days of the date on which Respondent signed the proposed Consent Agreement, and every thirty (30) days thereafter until the divestitures are completed, and annually for ten (10) years. The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Decision and Order and the Order to Maintain Assets, or to modify their terms in any way. By direction of the Commission. Donald S. Clark, Secretary of the Commission. [FR Doc. E8–17868 Filed 8–4–08: 8:45 am] [BILLING CODE 6750–01–S] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Impact of Cultural and Socioeconomic Factors on PostTreatment Surveillance Among African Americans With Colorectal Cancer, Potential Extramural Project 2008–R– 03 Notice of Cancellation: This notice was published in the Federal Register on July 22, 2008, Volume 73, Number 141, page 42576. The meeting previously scheduled to convene on August 6, 2008 has been cancelled. Contact Person for More Information: Linda Shelton, Program Specialist, Coordinating Center for Health and Information Service, Office of the Director, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E21, Atlanta, GA 30333, Telephone (404) 498–1194. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: July 28, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8–17913 Filed 8–4–08; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Description: This proposed information collection activity is an extension of the follow-up survey of faith-based and community organizations participating in the Compassion Capital Fund (CCF) Impact Evaluation. The currently approved information collection will expire on December 31, 2008. This information collection request will include the agency’s request for an extension of the initial survey instruments for an additional three years. The CCF evaluation is an important opportunity to examine the effectiveness of the Compassion Capital Fund Demonstration program in meeting its objective of improving the capacity of faith-based and community organizations. The evaluation includes selected CCF-funded intermediary organizations that provide capacitybuilding services and the faith-based and community organizations that sought those services. The follow-up survey will be used to collect information from the faith-based and community based organizations on various areas of organizational capacity. The study design includes the random assignment of faith based and community organizations to either a treatment group that receives capacitybuilding services from a CCF intermediary grantee or to a control group that does not. The impact of the services provided by intermediaries, primarily through sub-awards and/or technical assistance (TA), will be determined by comparing the changes reported through the survey in organizational and service capacity of the recipient organizations with those of the control group. Respondents: Faith-based and community organizations included in the CCF impact evaluation. Proposed Information Collection Activity; Comment Request Proposed Projects Title: Compassion Capital Fund Impact Evaluation. OMB No.: 0970–0293. dwashington3 on PRODPC61 with NOTICES ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response Total annual burden hours Follow-up Survey ............................................................................................. 455 1 .42 191 Estimated Total Annual Burden Hours: ........................................................... ........................ ........................ ........................ 191 VerDate Aug<31>2005 14:19 Aug 04, 2008 Jkt 214001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1 45454 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 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 Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. E-mail address: OPREinfocollection@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. Dated: July 29, 2008. Brendan C. Kelly, OPRE Reports Clearance Officer. [FR Doc. E8–17721 Filed 8–4–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0391] Draft Guidance for Industry on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; Availability AGENCY: Food and Drug Administration, HHS. dwashington3 on PRODPC61 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Submission of Documentation in Applications for Parametric Release of Human and VerDate Aug<31>2005 14:19 Aug 04, 2008 Jkt 214001 Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.’’ This draft guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), or biologics license application (BLA). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 6, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; the Communications Staff (HFV–12), Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855; the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Marla Stevens-Riley, Center for Drug Evaluation and Research (HFD– 600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276– 9310; Deborah Trout, Center for Biologics Evaluation and Research (HFM– 675), Food and Drug Administration, 8800 Rockville Pike, Rockville, MD 20892, 301– 827–3031; or Mai Huynh, Center for Veterinary Medicine (HFV–142), Food and Drug Administration, 7500 Standish PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Pl., Rockville, MD 20855, 240–276– 8273. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.’’ The draft guidance addresses the information that should be submitted in an approved new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), or biologics license application (BLA) in support of parametric release for sterile products terminally sterilized by moist heat. ‘‘Parametric release’’ is defined as a sterility assurance release program where demonstrated control of the sterilization process enables a firm to use defined critical process controls, in lieu of the sterility test, to fulfill the intent of 21 CFR 211.167(a). Under this strategy, market release of terminally sterilized products can be based upon meeting the defined sterilization parameters and not on performing an approved sterility test. Meeting the requirements of the parametric release process can provide greater assurance that a batch meets the sterility requirement than can be achieved with a sterility test of finished units drawn from the batch. Parametric release allows manufacturers to replace sterility testing of samples drawn from the finished product as a release criterion with acceptance criteria for the control of identified process parameters. Parametric release of the batch is then based on documented evidence of the control of critical parameters, removing the need for testing of samples drawn from the finished product. An application to FDA is required to obtain approval for parametric release. The approval of parametric release is based on an assessment of the applicant’s proposed critical process parameters and how they are controlled. Demonstrated reliability of the production terminal sterilization cycle, microbiological control and monitoring, and control of production cycle parameters within established validated limits is part of this assessment. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on inclusion of recommended E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45453-45454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request 
Proposed Projects

    Title: Compassion Capital Fund Impact Evaluation.
    OMB No.: 0970-0293.
    Description: This proposed information collection activity is an 
extension of the follow-up survey of faith-based and community 
organizations participating in the Compassion Capital Fund (CCF) Impact 
Evaluation. The currently approved information collection will expire 
on December 31, 2008. This information collection request will include 
the agency's request for an extension of the initial survey instruments 
for an additional three years.
    The CCF evaluation is an important opportunity to examine the 
effectiveness of the Compassion Capital Fund Demonstration program in 
meeting its objective of improving the capacity of faith-based and 
community organizations. The evaluation includes selected CCF-funded 
intermediary organizations that provide capacity-building services and 
the faith-based and community organizations that sought those services. 
The follow-up survey will be used to collect information from the 
faith-based and community based organizations on various areas of 
organizational capacity.
    The study design includes the random assignment of faith based and 
community organizations to either a treatment group that receives 
capacity-building services from a CCF intermediary grantee or to a 
control group that does not. The impact of the services provided by 
intermediaries, primarily through sub-awards and/or technical 
assistance (TA), will be determined by comparing the changes reported 
through the survey in organizational and service capacity of the 
recipient organizations with those of the control group.
    Respondents: Faith-based and community organizations included in 
the CCF impact evaluation.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                   Instrument                        Number of     responses per   burden hours    Total annual
                                                    respondents     respondent     per response    burden hours
----------------------------------------------------------------------------------------------------------------
Follow-up Survey................................             455               1             .42             191
                                                 ---------------------------------------------------------------
Estimated Total Annual Burden Hours:............  ..............  ..............  ..............             191
----------------------------------------------------------------------------------------------------------------


[[Page 45454]]

    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 
Planning, Research and Evaluation, 370 L'Enfant Promenade, SW., 
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. E-mail 
address: OPREinfocollection@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.

    Dated: July 29, 2008.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E8-17721 Filed 8-4-08; 8:45 am]
BILLING CODE 4184-01-M
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