Draft Guidance for Industry on Advisory Committee Meetings: Preparation and Public Availability of Information Given to Advisory Committee Members; Availability, 9008-9009 [07-887]
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9008
Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 1271, subpart C have been
approved under OMB Control No. 0910–
0543. The collections of information in
part 1271, subpart D have been
approved under OMB Control No. 0910–
0559.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
guidance announced in 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 the brackets in
the heading of this document. A copy of
the guidance and received comments
are available for public examination in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cber/guidelines.htmor
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: February 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–3445 Filed 2–27–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on PROD1PC70 with NOTICES
[Docket No. 2007D–0021]
Draft Guidance for Industry on
Advisory Committee Meetings:
Preparation and Public Availability of
Information Given to Advisory
Committee Members; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
16:08 Feb 27, 2007
Jkt 211001
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Advisory Committee
Meetings—Preparation and Public
Availability of Information Given to
Advisory Committee Members.’’ This
guidance is intended to provide
information to industry sponsors,
applicants, and petitioners on the
development, preparation, or
submission of briefing materials that
will be given to advisory committee
members as background information
prior to open FDA advisory committee
meetings. The guidance will help
sponsors develop, organize, and submit
advisory committee briefing materials
for public release and should help
minimize the time and resources spent
in preparing these materials for public
availability. The guidance also describes
the process FDA intends to follow when
we make briefing materials available to
the public.
DATES: Submit written or electronic
comments on the draft guidance
document by April 30, 2007. General
comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to
Office of Policy (HF–11), Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist the
office in processing your request.
Submit written comments on the draft
guidance to 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 draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Poppy Kendall, Food and Drug
Administration (HF–11), 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3360, FAX: 301–594–6777, e-mail:
poppy.kendall@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Advisory Committee Meetings—
Preparation and Public Availability of
Information Given to Advisory
Committee Members.’’ This guidance
will help sponsors develop, prepare,
and submit advisory committee briefing
materials and should help minimize the
time and resources spent in preparing
these materials for public availability.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
The guidance also describes the process
FDA intends to follow when we make
briefing materials available to the
public. The term ‘‘briefing materials’’ is
used to describe the package of
information that we provide to advisory
committee members before a meeting,
and that usually contains information
prepared by us and/or the sponsor (if
the meeting involves an application or
particular product). In addition, the
Appendices to the draft guidance
provide timelines for preparing and
submitting briefing materials to FDA.
For open advisory committee
meetings for which the briefing
materials may contain information that
under certain circumstances could be
considered to be exempt from disclosure
under the Freedom of Information Act
(FOIA) (5 U.S.C. 552), we intend to post
the publicly available version of the
briefing materials on our Web site at
least 2 full business days before the
advisory committee meeting is
scheduled to occur. With respect to
meetings for which the briefing
materials do not contain information
that could be considered exempt from
disclosure under FOIA, we will
probably make the briefing materials
available on our Web site more than 2
full business days before the advisory
committee meeting is schedule to occur.
In the latter case, we anticipate that
meetings subject to this timeline will
normally address general matters such
as guidance documents and policy
issues related to FDA-regulated
products.
This draft guidance, which will
harmonize the preparation and public
availability of information given to
advisory committee members for all
products regulated by FDA, replaces
three previously issued draft guidances:
(1) ‘‘Disclosing Information Provided to
Advisory Committees in Connection
With Open Advisory Committee
Meetings Related to the Testing or
Approval of New Drugs and Convened
by the Center for Drug Evaluation and
Research, Beginning on January 1,
2000;’’ (2) ‘‘Disclosing Information
Provided to Advisory Committees in
Connection With Open Advisory
Committee Meetings Related to the
Testing or Approval of Biologic
Products and Convened by the Center
for Biologics Evaluation and Research;’’
and (3) ‘‘Availability of Information
Given to Advisory Committee Members
in Connection With the Center for
Devices and Radiological Health Open
Public Panel Meetings.’’ An important
goal of this guidance is to help ensure
that briefing materials are made
available to the public as provided
under section 10(b) of the Federal
E:\FR\FM\28FEN1.SGM
28FEN1
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
]]>Agencies
[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Notices]
[Pages 9008-9009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0021]
Draft Guidance for Industry on Advisory Committee Meetings:
Preparation and Public Availability of Information Given to Advisory
Committee Members; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Advisory
Committee Meetings--Preparation and Public Availability of Information
Given to Advisory Committee Members.'' This guidance is intended to
provide information to industry sponsors, applicants, and petitioners
on the development, preparation, or submission of briefing materials
that will be given to advisory committee members as background
information prior to open FDA advisory committee meetings. The guidance
will help sponsors develop, organize, and submit advisory committee
briefing materials for public release and should help minimize the time
and resources spent in preparing these materials for public
availability. The guidance also describes the process FDA intends to
follow when we make briefing materials available to the public.
DATES: Submit written or electronic comments on the draft guidance
document by April 30, 2007. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to Office of Policy (HF-11), Office of the Commissioner, Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send
one self-addressed adhesive label to assist the office in processing
your request. Submit written comments on the draft guidance to 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 draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Poppy Kendall, Food and Drug
Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, FAX: 301-594-6777, e-mail: poppy.kendall@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Advisory Committee Meetings--Preparation and Public
Availability of Information Given to Advisory Committee Members.'' This
guidance will help sponsors develop, prepare, and submit advisory
committee briefing materials and should help minimize the time and
resources spent in preparing these materials for public availability.
The guidance also describes the process FDA intends to follow when we
make briefing materials available to the public. The term ``briefing
materials'' is used to describe the package of information that we
provide to advisory committee members before a meeting, and that
usually contains information prepared by us and/or the sponsor (if the
meeting involves an application or particular product). In addition,
the Appendices to the draft guidance provide timelines for preparing
and submitting briefing materials to FDA.
For open advisory committee meetings for which the briefing
materials may contain information that under certain circumstances
could be considered to be exempt from disclosure under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), we intend to post the publicly
available version of the briefing materials on our Web site at least 2
full business days before the advisory committee meeting is scheduled
to occur. With respect to meetings for which the briefing materials do
not contain information that could be considered exempt from disclosure
under FOIA, we will probably make the briefing materials available on
our Web site more than 2 full business days before the advisory
committee meeting is schedule to occur. In the latter case, we
anticipate that meetings subject to this timeline will normally address
general matters such as guidance documents and policy issues related to
FDA-regulated products.
This draft guidance, which will harmonize the preparation and
public availability of information given to advisory committee members
for all products regulated by FDA, replaces three previously issued
draft guidances: (1) ``Disclosing Information Provided to Advisory
Committees in Connection With Open Advisory Committee Meetings Related
to the Testing or Approval of New Drugs and Convened by the Center for
Drug Evaluation and Research, Beginning on January 1, 2000;'' (2)
``Disclosing Information Provided to Advisory Committees in Connection
With Open Advisory Committee Meetings Related to the Testing or
Approval of Biologic Products and Convened by the Center for Biologics
Evaluation and Research;'' and (3) ``Availability of Information Given
to Advisory Committee Members in Connection With the Center for Devices
and Radiological Health Open Public Panel Meetings.'' An important goal
of this guidance is to help ensure that briefing materials are made
available to the public as provided under section 10(b) of the Federal
[[Page 9009]]
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]
BILLING CODE 4160-01-S
