Proposed Information Collection Activity; Comment Request; Proposed Project, 59535-59536 [07-5176]

Download as PDF 59535 Federal Register / Vol. 72, No. 203 / Monday, October 22, 2007 / Notices both CDC and the Agency for Toxic Substances and Disease Registry. Dated: October 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7–20699 Filed 10–19–07; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E7–20696 Filed 10–19–07; 8:45 am] Dated: October 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7–20688 Filed 10–19–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Centers for Disease Control and Prevention Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Centers for Disease Control and Prevention (CDC) Grants for Public Health Research Dissertation, Program Announcement (PA) PAR 07–231, Panel A Correction: This notice was published in the Federal Register on October 10, 2007, Volume 72, Number 195, page 57582. The time and date should read as follows: Time and Date: 8:30 a.m.–5 p.m., November 15, 2007 (Closed). Contact Person for More Information: Juliana Cyril, PhD, MPH, Scientific Review Administrator, Office of the Chief Science Officer, CDC, 1600 Clifton Road, NE., Mailstop D 72, Atlanta, GA 30333. Telephone (404) 639–4896. 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. Healthcare Infection Control Practices Advisory Committee (HICPAC) Correction: This notice was published in the Federal Register on October 11, 2007, Volume 72, Number 196, page 57947–57948. The Place should read as follows: Place: Department of Health and Human Services Building, 395 E Street, SW., Suite 9100, Washington, DC 20201. Contact Person for More Information: Angela B. Scott, Committee Management Specialist, HICPAC, Division of Healthcare Quality Promotion, NCPDCID, CDC, 1600 Clifton Road, N.E., Mailstop A 45, Atlanta, GA 30333. Telephone (404) 639–1526. 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. Proposed Information Collection Activity; Comment Request; Proposed Project Title: Compassion Capital Fund Impact Evaluation Process Study. OMB No.: New Collection. Description: The information collection activity proposed under this notice will obtain information about intermediary grantee agencies providing capacity building assistance to faithbased and community organizations under the Compassion Capital Fund (CCF) Demonstration program. The information gathered under this data collection activity will be used to describe the approach and methods used by intermediaries to provide the services that are being evaluated in the CCF impact evaluation. Information collection will be through informal discussions and observations on-site at the organizations, using uniform protocols. Respondents: Directors and staff providing technical assistance and related services to faith-based and community organizations and directors and staff in faith-based and community organizations that have received capacity building assistance. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response 10 30 30 60 1 1 1 1 3 1 2 1 ebenthall on PRODPC61 with NOTICES Intermediary Protocol for Executive Director ................................................... Intermediary Protocol for Key Staff ................................................................. Faith-based or Community Organization Protocol for Executive Director ...... Faith-based or Community Organization Protocol for Key Staff ..................... Estimated Total Annual Burden Hours: 180. In compliance with the requirements of Section 3506(c)(1)(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 VerDate Aug<31>2005 15:02 Oct 19, 2007 Jkt 214001 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 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 Total burden hours 30 30 60 60 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 E:\FR\FM\22OCN1.SGM 22OCN1 59536 Federal Register / Vol. 72, No. 203 / Monday, October 22, 2007 / Notices 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. the Internet at http://www.fda.gov/ ohrms/dockets. Dated: October 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–20756 Filed 10–19–07; 8:45 am] BILLING CODE 4160–01–S Dated: October 10, 2007. Brendan C. Kelly, Reports Clearance Officer. [FR Doc. 07–5176 Filed 10–19–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4184–01–M [Docket No. 2007N–0114] DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Distribution of Prescribing Information for Prescription Drug Products; Reopening of Comment Period Food and Drug Administration Food and Drug Administration AGENCY: ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4816. In the Federal Register of March 14, 2007 (72 FR 11889), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0611. The approval expires on October 31, 2010. A copy of the supporting statement for this information collection is available on ebenthall on PRODPC61 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 15:02 Oct 19, 2007 Food and Drug Administration, HHS. [Docket No. 2006N–0133] Jkt 214001 Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening to December 6, 2007 the comment period for the notice that published in the Federal Register of April 2, 2007 (72 FR 15701); this notice was related to the public hearing of April 27, 2007, concerning the electronic distribution of FDA-approved prescribing information currently contained in the package insert (PI) for prescription drug and biological products. FDA is reopening the comment period for the sole purpose of inviting interested persons to submit comments on the concept of electronic distribution of FDA-approved prescribing information currently contained in the PI for prescription animal drug products. DATES: Submit written or electronic comments by December 6, 2007. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either http:// www.fda.gov/dockets/ecomments or http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF–11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 3360, Erik.Mettler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register notice of April 2, 2007 (72 FR 15701), FDA published a notice of public hearing concerning the concept of the electronic distribution of PIs for human prescription drugs and biological PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 products and solicited relevant information and comments on this concept. The purpose was to garner views and information on the feasibility of establishing an efficient process for industry to electronically distribute prescribing information to dispensers. The PIs with prescribing information accompany prescription human drugs to meet the requirement that ‘‘labeling on or within the package from which the drug is to be dispensed bears adequate information for its use * * *’’ (21 CFR 201.100(c)(1)). For additional information, see the April 2, 2007, notice ( 72 FR 15701). Currently, the PI contains the prescribing information for the safe and effective use of the product in the form of a paper leaflet. Although the information in the PI is a valuable resource, it is often not readily accessible when a healthcare provider who has not physically received the drug makes a treatment decision or discusses treatments with a patient. Additionally, the PI may not contain the most current information, because the PI accompanying the drug’s distribution may have been printed and distributed prior to more recent labeling changes. Accordingly, with technological advances in the electronic transmission of information, we are considering how prescribing information could be more effectively disseminated. FDA is reopening the comment period for the sole purpose of inviting interested persons to submit comments addressing a number of questions regarding the current use of package inserts for animal drug products and those logistical issues associated with electronic distribution of such prescribing information for animal drug products. The previous request for comments was limited to human drugs and biologics. As with prescription human drugs, the PIs with prescribing information accompany prescription animal drugs to meet the requirement that ‘‘labeling on or within the package from which the drug is to be dispensed bears adequate information for its use * * *’’ (21 CFR 201.105(c)(1)). FDA approves the prescribing information as part of both human and animal drug labeling in the drug application. The request for comment is to gain a better understanding of how PIs for animal drugs are currently used by healthcare entities as we consider new approaches for the dissemination of labeling information. II. Issues for Discussion FDA is specifically interested in receiving comments on the following questions and any other pertinent E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 72, Number 203 (Monday, October 22, 2007)]
[Notices]
[Pages 59535-59536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request; 
Proposed Project

    Title: Compassion Capital Fund Impact Evaluation Process Study.
    OMB No.: New Collection.
    Description: The information collection activity proposed under 
this notice will obtain information about intermediary grantee agencies 
providing capacity building assistance to faith-based and community 
organizations under the Compassion Capital Fund (CCF) Demonstration 
program. The information gathered under this data collection activity 
will be used to describe the approach and methods used by 
intermediaries to provide the services that are being evaluated in the 
CCF impact evaluation. Information collection will be through informal 
discussions and observations on-site at the organizations, using 
uniform protocols.
    Respondents: Directors and staff providing technical assistance and 
related services to faith-based and community organizations and 
directors and staff in faith-based and community organizations that 
have received capacity building assistance.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Intermediary Protocol for Executive Director....              10               1               3              30
Intermediary Protocol for Key Staff.............              30               1               1              30
Faith-based or Community Organization Protocol                30               1               2              60
 for Executive Director.........................
Faith-based or Community Organization Protocol                60               1               1              60
 for Key Staff..................................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 180.
    In compliance with the requirements of Section 3506(c)(1)(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 practical utility; (b) the accuracy of the 
agency's estimate of the burden of the

[[Page 59536]]

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. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

    Dated: October 10, 2007.
Brendan C. Kelly,
Reports Clearance Officer.
[FR Doc. 07-5176 Filed 10-19-07; 8:45 am]
BILLING CODE 4184-01-M