Agency Information Collection Activities. Proposed Collection: Comment Request, 9009-9010 [E7-3446]

Download as PDF 9009 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices Advisory Committee Act (5 U.S.C. app. 2). The guidance includes recommendations on how to identify information that is exempt from public disclosure under the FOIA. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if the approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/opacom/morechoices/ industry/guidedc.htm. Dated: January 24, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07–887 Filed 2–26–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities. Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited 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) ways to enhance 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 the use of automated collection techniques or other forms of information technology. Proposed Project: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Regulations and Forms (OMB No. 0915–0126)—Extension The National Practitioner Data Bank (NPDB) was established through Title IV of Public Law (P.L.) 99–660, the Health Care Quality Improvement Act of 1986, BILLING CODE 4160–01–S Number of respondents sroberts on PROD1PC70 with NOTICES Regulation citation 60.6(a) Errors & Omissions ......................................................................... 60.6(b) Revisions to Actions ........................................................................ 60.7(b) Medical Malpractice Payment Report ............................................. 60.8(b) Adverse Action Reports—State Boards .......................................... 60.9(a)3 Adverse Action Clinical Privileges & Professional Society ........... Requests for Hearings by Entities ............................................................... 60.10(a)(1) Queries by Hospital—Practitioner Applications ........................ 60.10(a)(2) Queries by Hospitals—Two Yr. Cycle ...................................... 60.11(a)(1) Disclosure to Hospitals ............................................................. 60.11(a)(2) Disclosure to Practitioners (Self-Query) ................................... 60.11(a)(3) Disclosure to Licensure Boards ................................................ 60.11(a)(4) Queries by Non-Hospital Health Care Entities ......................... 60.11(a)(5) Queries by Plaintiffs’ Attorneys ................................................ 60.11(a)(6) Queries by Non-Hospital Health Care Entities—Peer Review VerDate Aug<31>2005 17:43 Feb 27, 2007 Jkt 211001 PO 00000 Frm 00051 Fmt 4703 303 115 485 0 686 1 6,000 6,000 0 0 80 4,938 5 0 Sfmt 4703 as amended. Final regulations governing the NPDB are codified at 45 CFR part 60. Responsibility for NPDB implementation and operation resides in the Bureau of Health Professions, Health Resources and Services Administration, Department of Health and Human Services (HHS). The NPDB began operation on September 1, 1990. The intent of Title IV of P.L. 99–660 is to improve the quality of health care by encouraging hospitals, State licensing boards, professional societies, and other entities providing health care services, to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State to State without disclosure of the practitioner’s previous damaging or incompetent performance. The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners’ professional credentials and background. Information on medical malpractice payments, adverse licensure actions, adverse clinical privileging actions, adverse professional society actions, and Medicare/Medicaid exclusions is collected from, and disseminated to, eligible entities. It is intended that NPDB information should be considered with other relevant information in evaluating a practitioner’s credentials. The reporting forms and the request for information forms (query forms) are accessed, completed, and submitted to the NPDB electronically through the NPDB Web site at https://www.npdbhipdb.hrsa.gov. All reporting and querying is performed through this secure Web site. Due to overlap in requirements for the Healthcare Integrity and Protection Data Bank (HIPDB), some of the NPDB’s burden has been subsumed under the HIPDB. Estimates of Annualized Burden are as Follows: Frequency of responses 5 1.1 39 0 1.5 1 37.3 149 0 0 225 437 5 0 E:\FR\FM\28FEN1.SGM 28FEN1 Hours per response (minutes) 15 30 45 0 45 480 5 5 0 0 5 5 30 0 Total burden hours 385 64 14,236 0 785 8 18,615 74,461 0 0 1,499 179,673 3.0 0 9010 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices Number of respondents Regulation citation 60.11(a)(7) Requests by Researchers for Aggregated Data ...................... 60.14(b) Practitioner Places a Report in Disputed Status .......................... 60.14(b) Practitioner Statement ................................................................... 60.14(b) Practitioner Requests for Secretarial Review ............................... 60.3 Entity Registration—Initial ................................................................... 60.3 Entity Registration—Update ................................................................ 60.11(a) Authorized Agent Designation—Initial .......................................... 60.11(a) Authorized Agent-Update .............................................................. 60.12(c) Account Discrepancy Report ......................................................... 60.12(c) Electronic Funds Transfer Authorization ....................................... 60.3 Entity Reactivation ............................................................................... 100 666 2,563 117 500 643 500 86 300 363 100 Total ...................................................................................................... ........................ Hours per response (minutes) Frequency of responses 1 1 1 1 1 1 1 1 1 1 1 .......................... Total burden hours 30 5 45 480 60 5 15 5 15 15 60 50 55 1,922 936 500 54 125 7 75 91 100 ........................ 293,644 Numbers in the table may not add up exactly due to rounding. Send comments to Susan Queen, PhD, HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received within 60 days of this notice. Dated: February 22, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–3446 Filed 2–27–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting sroberts on PROD1PC70 with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Commission on Childhood Vaccines (ACCV). Date and Time: March 7, 2007, 1 p.m.–5 p.m., EST. March 8, 2007, 9 a.m.–3:30 p.m., EST. Place: Audio Conference Call and Parklawn Building, Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857. The ACCV will meet on Wednesday, March 7, from 1 p.m. to 5 p.m., and on Thursday, March 8, from 9 a.m. to 3:30 p.m. The public can join the meeting in person at the address listed above or by audio conference call by dialing 1–888–947–9967 on March 7 and 8 and providing the following information: Leader’s Name: Dr. Geoffrey Evans. Password: ACCV. Agenda: The agenda items for the March meeting will include, but are not limited to: A discussion of VICP outreach activities; an overview of the Vaccine Adverse Event Reporting System, including the requirements for the reporting of adverse events; a report from the ACCV Futures Workgroup; and updates from the Division of VerDate Aug<31>2005 17:43 Feb 27, 2007 Jkt 211001 Vaccine Injury Compensation (DVIC), Department of Justice, National Vaccine Program Office, Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health), and Center for Biologics and Evaluation Research (Food and Drug Administration). Agenda items are subject to change as priorities dictate. Public Comments: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation, to: Ms. Cheryl Lee, Principal Staff Liaison, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C–26, 5600 Fishers Lane, Rockville, MD 20857 or e-mail: clee@hrsa.gov. Requests should contain the name, address, telephone number, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the comment period. These persons will be allocated time as it permits. For Further Information Contact: Anyone requiring information regarding the ACCV should contact Ms. Cheryl Lee, Principal Staff Liaison, DVIC, HSB, HRSA, Room 11C– 26, 5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443–2124 or e-mail: clee@hrsa.gov. Notification: Due to inclement weather, the requirement that the public be notified of this meeting at least 15 calendar days in advance was not met. Dated: February 22, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–3559 Filed 2–27–07; 8:45 am] BILLING CODE 4165–15–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Request for Genetic Studies in a Cohort of U.S. Radiologic Technologists SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 29, 2006, pages 78445–78446 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection Title: Genetic Studies in a Cohort of U.S. Radiologic Technologists (formerly known as ‘‘Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists’’). Type of Information Collection Request: Renewal with change of a previously approved collection (OMB No. 0925–0405, expiration 02/28/2007). Need and Use of Information Collection: The primary aim of this collection is to substantially increase knowledge about the possible modifying role of genetic variation on the long-term health effects associated with protracted low-to moderate-dose E:\FR\FM\28FEN1.SGM 28FEN1

Agencies

[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Notices]
[Pages 9009-9010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3446]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities. Proposed Collection:
Comment Request

In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Public Law 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, call the HRSA Reports Clearance
Officer on (301) 443-1129.
Comments are invited 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) ways to enhance 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 the use of automated collection techniques or other forms of
information technology.

Proposed Project: National Practitioner Data Bank for Adverse
Information on Physicians and Other Health Care Practitioners:
Regulations and Forms (OMB No. 0915-0126)--Extension

The National Practitioner Data Bank (NPDB) was established through
Title IV of Public Law (P.L.) 99-660, the Health Care Quality
Improvement Act of 1986, as amended. Final regulations governing the
NPDB are codified at 45 CFR part 60. Responsibility for NPDB
implementation and operation resides in the Bureau of Health
Professions, Health Resources and Services Administration, Department
of Health and Human Services (HHS). The NPDB began operation on
September 1, 1990.
The intent of Title IV of P.L. 99-660 is to improve the quality of
health care by encouraging hospitals, State licensing boards,
professional societies, and other entities providing health care
services, to identify and discipline those who engage in unprofessional
behavior; and to restrict the ability of incompetent physicians,
dentists, and other health care practitioners to move from State to
State without disclosure of the practitioner's previous damaging or
incompetent performance.
The NPDB acts primarily as a flagging system; its principal purpose
is to facilitate comprehensive review of practitioners' professional
credentials and background. Information on medical malpractice
payments, adverse licensure actions, adverse clinical privileging
actions, adverse professional society actions, and Medicare/Medicaid
exclusions is collected from, and disseminated to, eligible entities.
It is intended that NPDB information should be considered with other
relevant information in evaluating a practitioner's credentials.
The reporting forms and the request for information forms (query
forms) are accessed, completed, and submitted to the NPDB
electronically through the NPDB Web site at https://www.npdb-
hipdb.hrsa.gov. All reporting and querying is performed through this
secure Web site. Due to overlap in requirements for the Healthcare
Integrity and Protection Data Bank (HIPDB), some of the NPDB's burden
has been subsumed under the HIPDB.
Estimates of Annualized Burden are as Follows:

----------------------------------------------------------------------------------------------------------------
Hours per
Regulation citation Number of Frequency of response Total burden
respondents responses (minutes) hours
----------------------------------------------------------------------------------------------------------------
60.6(a) Errors & Omissions.................... 303 5 15 385
60.6(b) Revisions to Actions.................. 115 1.1 30 64
60.7(b) Medical Malpractice Payment Report.... 485 39 45 14,236
60.8(b) Adverse Action Reports--State Boards.. 0 0 0 0
60.9(a)3 Adverse Action Clinical Privileges & 686 1.5 45 785
Professional Society.........................
Requests for Hearings by Entities............. 1 1 480 8
60.10(a)(1) Queries by Hospital--Practitioner 6,000 37.3 5 18,615
Applications.................................
60.10(a)(2) Queries by Hospitals--Two Yr. 6,000 149 5 74,461
Cycle........................................
60.11(a)(1) Disclosure to Hospitals........... 0 0 0 0
60.11(a)(2) Disclosure to Practitioners (Self- 0 0 0 0
Query).......................................
60.11(a)(3) Disclosure to Licensure Boards.... 80 225 5 1,499
60.11(a)(4) Queries by Non-Hospital Health 4,938 437 5 179,673
Care Entities................................
60.11(a)(5) Queries by Plaintiffs' Attorneys.. 5 5 30 3.0
60.11(a)(6) Queries by Non-Hospital Health 0 0 0 0
Care Entities--Peer Review...................

[[Page 9010]]

60.11(a)(7) Requests by Researchers for 100 1 30 50
Aggregated Data..............................
60.14(b) Practitioner Places a Report in 666 1 5 55
Disputed Status..............................
60.14(b) Practitioner Statement............... 2,563 1 45 1,922
60.14(b) Practitioner Requests for Secretarial 117 1 480 936
Review.......................................
60.3 Entity Registration--Initial............. 500 1 60 500
60.3 Entity Registration--Update.............. 643 1 5 54
60.11(a) Authorized Agent Designation--Initial 500 1 15 125
60.11(a) Authorized Agent-Update.............. 86 1 5 7
60.12(c) Account Discrepancy Report........... 300 1 15 75
60.12(c) Electronic Funds Transfer 363 1 15 91
Authorization................................
60.3 Entity Reactivation...................... 100 1 60 100
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Total..................................... .............. ............... .............. 293,644
----------------------------------------------------------------------------------------------------------------
Numbers in the table may not add up exactly due to rounding.

Send comments to Susan Queen, PhD, HRSA Reports Clearance Officer,
Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland
20857. Written comments should be received within 60 days of this
notice.

Dated: February 22, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-3446 Filed 2-27-07; 8:45 am]
BILLING CODE 4165-15-P

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