Agency Information Collection Activities: Submission for OMB Review-Comment Request, 26135-26136 [E7-8796]
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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rule and on the draft guidance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of the draft guidance may do so by using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 To receive the draft
guidance document entitled ‘‘Class II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
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents are also available on the
Division of Dockets Management
Internet site at https://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comments on the draft guidance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 https://
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
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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 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:
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]
-----------------------------------------------------------------------
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 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 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
