Agency Information Collection Activities: Submission for OMB Review-Comment Request, 26135-26136 [E7-8796]

Download as PDF Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices rule and on the draft guidance document by January 29, 2007. Two companies requested FDA to extend the comment period on the proposed rule by 90 days because the proposal presented complex medical and scientific issues that required the company to assemble a team of many different specialties in order to prepare their comments. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on the proposed rule for 30 days. Because the issues presented by the guidance document are intertwined with those presented by the proposed rule, FDA is reopening the comment period on the guidance document for the same period. cprice-sewell on PROD1PC66 with NOTICES II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive the draft guidance document entitled ‘‘Class II Special Controls Document: Absorbable Hemostatic Device,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document, or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number 1558 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved submissions, approved applications, and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ ohrms/dockets. III. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance document.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 VerDate Aug<31>2005 15:36 May 07, 2007 Jkt 211001 document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–8780 Filed 5–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0027] Voluntary Self-Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening to June 8, 2007, the comment period for the notice of availability that appeared in the Federal Register of February 12, 2007 (72 FR 6572). In the notice, FDA requested comments on the draft compliance policy guide on voluntary self-inspection of medicated feed manufacturing facilities. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written and electronic comments by June 8, 2007. ADDRESSES: Submit written comments on the draft compliance policy guide 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Paul Bachman, Center for Veterinary Medicine (HFV–230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9225, email: Paul.Bachman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 12, 2007 (72 FR 6572), FDA published a notice of availability with a 75-day comment period to request comments on a draft compliance policy guide (CPG) on voluntary self inspection of PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 26135 medicated feed manufacturing facilities. The purpose of this CPG is intended to provide guidance to FDA field offices on considering, among other factors, the conduct of self-inspections when prioritizing inspections of medicated feed manufacturing facilities for compliance with Current Good Manufacturing Practices for Medicated Feeds regulations. The agency has received a request for an extension of the comment period for the draft compliance policy guide. This request conveyed concern that the current 75-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the compliance policy guide. FDA has considered the request and is reopening the comment period for the draft compliance policy guide until June 8, 2007. The agency believes this reopening allows adequate time for interested persons to submit comments. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on these documents. 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 1, 2007. David Horowitz, Assistant Commissioner for Regulatory Affairs. [FR Doc. E7–8781 Filed 5–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review—Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. E:\FR\FM\08MYN1.SGM 08MYN1 26136 Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices The following request has been submitted to OMB for review under the Paperwork Reduction Act of 1995: 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 (Pub. 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. The NPDB began operation on September 1, 1990. The intent of Title IV of Pub. 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-toState 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 No. of respondents Regulation citation 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 http://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: Hours per response (minutes) Frequency of responses Total burden hours 60.6(a) Errors & Omissions ............................................................................. 60.6(b) Revisions to Actions ............................................................................ 60.7(b) Medical Malpractice Payment Reports ............................................... 60.8(b) Adverse Action Reports—State Boards .............................................. 60.9(a)3 Adverse Action Reports—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—2 Year 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 ....... 60.11(a)(7) Requests by Researchers for Aggregate 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 ................................................................................... 315 109 519 0 480 0 0 5,996 0 0 87 7,305 5 0 20 404 1,415 27 1,447 13,115 717 139 5 284 0 4 1 29 0 2 0 0 213 0 0 645 322 1 0 1 1 1 1 1 1 1 1 1 1 1 15 30 45 0 45 480 0 5 0 0 5 5 30 0 30 15 45 480 60 5 15 5 15 15 315 54.5 11,288.25 720 0 0 106,429 0 0 4,676.25 196,017.5 2.5 0 10 101 1,061.25 216 1,447 1,092.92 179.25 11.58 1.25 71 Total Burden Hours .................................................................................. ........................ ........................ ........................ 323,694.25 cprice-sewell on PROD1PC66 with NOTICES Numbers in the table may not add up exactly due to rounding. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 2, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7–8796 Filed 5–7–07; 8:45 am] Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget BILLING CODE 4165–15–P VerDate Aug<31>2005 15:36 May 07, 2007 Jkt 211001 Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office at (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Pages 26135-26136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review--Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301) 443-1129.

[[Page 26136]]

    The following request has been submitted to OMB for review under 
the Paperwork Reduction Act of 1995:

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 (Pub. 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. The NPDB began operation on September 1, 
1990.
    The intent of Title IV of Pub. 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 http://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                    No. of       Frequency of      response      Total burden
                                                    respondents      responses       (minutes)         hours
----------------------------------------------------------------------------------------------------------------
60.6(a) Errors & Omissions......................             315               4              15             315
60.6(b) Revisions to Actions....................             109               1              30            54.5
60.7(b) Medical Malpractice Payment Reports.....             519              29              45       11,288.25
60.8(b) Adverse Action Reports--State Boards....               0               0               0
60.9(a)3 Adverse Action Reports--Clinical                    480               2              45             720
 Privileges & Professional Society..............
Requests for Hearings by Entities...............               0               0             480               0
60.10(a)(1) Queries by Hospital--Practitioner                  0               0               0               0
 Applications...................................
60.10(a)(2) Queries by Hospitals--2 Year Cycle..           5,996             213               5         106,429
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......              87             645               5        4,676.25
60.11(a)(4) Queries by Non-Hospital Health Care            7,305             322               5       196,017.5
 Entities.......................................
60.11(a)(5) Queries by Plaintiffs' Attorneys....               5               1              30             2.5
60.11(a)(6) Queries by Non-Hospital Health Care                0               0               0               0
 Entities-Peer Review...........................
60.11(a)(7) Requests by Researchers for                       20               1              30              10
 Aggregate Data.................................
60.14(b) Practitioner Places a Report in                     404               1              15             101
 Disputed Status................................
60.14(b) Practitioner Statement.................           1,415               1              45        1,061.25
60.14(b) Practitioner Requests for Secretarial                27               1             480             216
 Review.........................................
60.3 Entity Registration--Initial...............           1,447               1              60           1,447
60.3 Entity Registration--Update................          13,115               1               5        1,092.92
60.11(a) Authorized Agent Designation--Initial..             717               1              15          179.25
60.11(a) Authorized Agent--Update...............             139               1               5           11.58
60.12(c) Account Discrepancy Report.............               5               1              15            1.25
60.12(c) Electronic Funds Transfer Authorization             284               1              15              71
60.3 Entity Reactivation........................               0               1
                                                 ---------------------------------------------------------------
    Total Burden Hours..........................  ..............  ..............  ..............     323,694.25
----------------------------------------------------------------------------------------------------------------
 Numbers in the table may not add up exactly due to rounding.

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Karen Matsuoka, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: May 2, 2007.
Caroline Lewis,
Associate Administrator for Management.
 [FR Doc. E7-8796 Filed 5-7-07; 8:45 am]
BILLING CODE 4165-15-P