Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB), 16138-16139 [2010-6999]

Download as PDF 16138 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices TABLE 1.—EXPORT CERTIFICATES Type of Certificate Use ‘‘Supplementary Information Certificate to Foreign Government Requests’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government (For Human Tissue Intended for Transplantation)’’ For the export of products legally marketed in the United States ‘‘Supplementary Information Certificate of Exportability Requests’’ ‘‘Exporter’s Certification Statement Certificate of Exportability’’ For the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of sections 801(e) or 802 of the act ‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ ‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical Product’’ Conforms to the format established by the World Health Organization and is intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or reviewing a license ‘‘Supplementary Information Non-Clinical Research Use Only Certificate’’ ‘‘Exporter’s Certification Statement Non-Clinical Research Use Only)’’ For the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the act Certificate of Free Sale For food, cosmetic products, and dietary supplements that may be legally marketed in the United States FDA will continue to rely on selfcertification by manufacturers for the first three types of certificates listed in table 1 of this document. Manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the act, not only at the time that they submit their request to Investigations for followup. Making or submitting to FDA false statements on any documents may constitute violations of 18 U.S.C. 1001, with penalties including up to $250,000 in fines and up to 5 years imprisonment. FDA estimates the burden of this collection of information as follows: the appropriate center, but also at the time that they submit the certification to the foreign government. The appropriate FDA centers will review product information submitted by firms in support of their certificate and any suspected case of fraud will be referred to FDA’s Office of Criminal TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1 FDA Center No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Center for Biologics Evaluation and Research 2,114 1 2,114 1 2,114 Center for Drug Evaluation and Research 5,251 1 5,251 2 10,502 Center for Devices and Radiological Health 6,463 1 6,463 2 12,926 Center for Veterinary Medicine 855 1 855 1 855 1,794 5 8,970 2 17,940 Center for Food Safety and Applied Nutrition Total 1 There 44,337 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 25, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–7111 Filed 3–30–10; 8:45 am] jlentini on DSKJ8SOYB1PROD with NOTICES BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB) Title: Strengthening Communities Fund Program Evaluation. VerDate Nov<24>2008 19:40 Mar 30, 2010 Jkt 220001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 OMB No.: New collection. Description: This proposed information collection activity is to obtain evaluation information from Strengthening Communities Fund (SCF) grantees. Grantees include participants in two SCF grant programs contributing to the economic recovery as authorized in the American Recovery and Reinvestment Act of 2009 (ARPA). The SCF evaluation is an important opportunity to examine the outcomes E:\FR\FM\31MRN1.SGM 31MRN1 16139 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices achieved by the Strengthening Communities Fund in meeting its objective of improving the capacity of grantees that include Nonprofit organizations and State, Local and Tribal Governments. The evaluation for each program will be designed to assess progress and measure increased organizational capacity of grantees is each of the two SCF programs. The purpose of this request will be to establish the approved baseline instruments for follow-up data collection. Respondents: SCF Grantees (both the Nonprofit Capacity Building Program and the Government Capacity Building Program) made up of State, local, and Tribal governments, as well as nonprofit organizations. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Nonprofit Capacity Building Program Performance Progress Report (PPR) .. Government Capacity Building PPR ................................................................ Estimated Total Annual Burden Hours: 336. Additional Information: ACF is requesting that OMB grant a 180 day approval for this information collection under procedures for emergency processing by April 15, 2010. A copy of this information collection, with applicable supporting documentation, may be obtained by calling the Administration for Children and Families, Reports Clearance Officer, Robert Sargis at (202) 690–7275. Comments and questions about the information collection described above should be directed to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ACF, Office of Management and Budget, Paperwork Reduction Project, 725 17th Street NW., Washington, DC 20503, FAX (202) 395– 6974. Dated: March 22, 2010. Robert Sargis, Reports Clearance Officer. [FR Doc. 2010–6999 Filed 3–30–10; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request For Public Comment: 30-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files Indian Health Service, HHS. Notice. AGENCY: jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. VerDate Nov<24>2008 19:40 Mar 30, 2010 Jkt 220001 Frm 00074 Fmt 4703 Sfmt 4703 Average burden hours per response 4 4 1 1 35 49 This proposed information collection project was previously published in the Federal Register (74 FR 63754) on December 4, 2009 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917– 0009, ‘‘Indian Health Service Medical Staff Credentials and Privileges Files.’’ Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917–0009, ‘‘Indian Health Service Medical Staff Credentials and Privileges Files’’ agreement. Form Numbers(s): None. Need and Use of Information Collection: This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. The Department of Health and Human Services operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these services, the IHS employs (directly and under contract) several categories of health care providers including: Physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physician assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives. IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility’s capabilities and medical staff bylaws. There are three types of IHS medical staff applicants: (1) Health care providers applying for direct employment with IHS; (2) contractors who will not seek to become IHS employees; and (3) employed IHS health PO 00000 Number of responses per respondent Total burden hours 140 196 care providers who seek to transfer between IHS health care facilities. National health care standards developed by the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and other accrediting organizations require health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. In order to meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. In addition to the initial granting of medical staff membership and clinical privileges, JCAHO standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty. The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is not optional; such records must be established and accredited by JCAHO. Prior to the establishment of this JCAHO requirement, the degree to which medical staff applications were E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16138-16139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Agency Recordkeeping/Reporting Requirements Under Emergency 
Review by the Office of Management and Budget (OMB)

    Title: Strengthening Communities Fund Program Evaluation.
    OMB No.: New collection.
    Description: This proposed information collection activity is to 
obtain evaluation information from Strengthening Communities Fund (SCF) 
grantees. Grantees include participants in two SCF grant programs 
contributing to the economic recovery as authorized in the American 
Recovery and Reinvestment Act of 2009 (ARPA). The SCF evaluation is an 
important opportunity to examine the outcomes

[[Page 16139]]

achieved by the Strengthening Communities Fund in meeting its objective 
of improving the capacity of grantees that include Nonprofit 
organizations and State, Local and Tribal Governments. The evaluation 
for each program will be designed to assess progress and measure 
increased organizational capacity of grantees is each of the two SCF 
programs. The purpose of this request will be to establish the approved 
baseline instruments for follow-up data collection.
    Respondents: SCF Grantees (both the Nonprofit Capacity Building 
Program and the Government Capacity Building Program) made up of State, 
local, and Tribal governments, as well as nonprofit organizations.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Nonprofit Capacity Building Program Performance               35               4               1             140
 Progress Report (PPR)..........................
Government Capacity Building PPR................              49               4               1             196
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 336.
    Additional Information: ACF is requesting that OMB grant a 180 day 
approval for this information collection under procedures for emergency 
processing by April 15, 2010. A copy of this information collection, 
with applicable supporting documentation, may be obtained by calling 
the Administration for Children and Families, Reports Clearance 
Officer, Robert Sargis at (202) 690-7275.
    Comments and questions about the information collection described 
above should be directed to the Office of Information and Regulatory 
Affairs, Attn: OMB Desk Officer for ACF, Office of Management and 
Budget, Paperwork Reduction Project, 725 17th Street NW., Washington, 
DC 20503, FAX (202) 395-6974.

    Dated: March 22, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-6999 Filed 3-30-10; 8:45 am]
BILLING CODE 4184-01-M