Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability, 35436-35437 [E6-9653]
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35436
Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0228]
Draft Guidance for Industry and Food
and Drug Administration Staff; the
Review and Inspection of Premarket
Approval Applications Under the
Bioresearch Monitoring Program;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
I. Background
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘The Review and Inspection of
Premarket Approval Applications under
the Bioresearch Monitoring Program.’’
One of the performance goals,
referenced in a letter to Congress from
the Secretary of Health and Human
Services that accompanied the Medical
Device User Fee and Modernization Act
of 2002 (MDUFMA) legislation, includes
a commitment to improve FDA’s
scheduling and timeliness of
preapproval inspections. This draft
guidance document is intended to assist
applicants in understanding the process
involved in the bioresearch monitoring
(BIMO) review of the clinical and
nonclinical information in their
premarket approval application (PMA)
and the process involved in any related
inspections. Premarket notification
(510(k)) submissions are not addressed
in this draft guidance because a
premarket inspection is not ordinarily
conducted for 510(k)s. This draft
guidance is not final nor is it in effect
at this time.
DATES: Submit written or electronic
comments on this draft guidance by
September 18, 2006.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘The Review and
Inspection of Premarket Approval
Applications under the Bioresearch
Monitoring Program’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance to the Division of
rwilkins on PROD1PC63 with NOTICES
SUMMARY:
VerDate Aug<31>2005
17:31 Jun 19, 2006
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.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Matthew J. Tarosky, Center for Devices
and Radiological Health (HFZ–310),
Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 240–
270–0243.
SUPPLEMENTARY INFORMATION:
Jkt 208001
On October 26, 2002, MDUFMA
(Public Law 107–250) was signed into
law. Among other things, MDUMFA
authorized the collection of user fees to
improve the performance and
predictability of FDA’s device review
program, including PMAs. FDA, in
consultation with the regulated
industry, agreed to dedicate user fees to
helping the agency meet the
performance goals outlined in a letter
from the Secretary of Health and Human
Services to Congress that accompanied
the user fee legislation. One such goal
included a commitment to ‘‘improve the
scheduling and timeliness of
preapproval inspections.’’ A portion of
the user fees collected under MDUFMA
will be used to help to cover the costs
associated with the BIMO program
review of the PMA and the performance
of any clinical or nonclinical
inspections. FDA will monitor its BIMO
preapproval inspection program and
include this information in its annual
performance report to Congress.
This draft guidance provides
information about the administrative
process and timeframes within which
the BIMO review of the PMA clinical
and nonclinical sections should be
completed. Use of this draft guidance
should facilitate FDA’s timely review
and inspection of the PMA clinical and
nonclinical information and improve
the coordination of a preapproval
inspection between the applicant and
FDA.
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may also do so by
using the Internet. To receive ‘‘The
Review and Inspection of Premarket
Approval Applications under the
Bioresearch Monitoring Program,’’ 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 1602 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 applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-related information.
The CDRH web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
II. Significance of Guidance
IV. Paperwork Reduction Act of 1995
This draft 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 USC 3501–3520) (the PRA). The
collections of information addressed in
21 CFR part 814 have been approved by
OMB under OMB Control No. 0910–
0231.
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 the agency’s current thinking
on ‘‘The Review and Inspection of
Premarket Approval Applications under
the Bioresearch Monitoring Program.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
V. 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 copy.
Comments are to be identified with the
docket number found in brackets in the
PO 00000
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Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Notices
heading of this document. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9653 Filed 6–19–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rwilkins on PROD1PC63 with NOTICES
Submission for OMB review; Comment
Request; Environmental Factors in the
Development of Polycystic Ovary
Syndrome
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Environmental Health
Sciences (NIEHS), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 20,
2006, pages 3310–3311 and allowed 60days 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:
Environmental Factors in the
Development of Polycystic Ovary
Syndrome.
Type of Information Collection
Request: Revision of OMB No. 0925–
0483 and expiration date 3/31/2006.
Need and Use of Information
Collection: The purpose of this study is
to identify a cohort of living female twin
pairs in which at least one member is
likely to have Polycystic Ovary
Syndrome (PCOS) for future study.
Potential participants (-2,200) will come
from the Mid-Atlantic Twin Registry
(MATR) and were chosen based on their
answers to several questions (in a
preliminary MATR survey) concerning
irregular periods and a history of
polycystic cystic ovaries. The
instrument to be used here will be
administered by telephone by
professional interviewers at the MATR.
It contains 17 simple and direct
VerDate Aug<31>2005
18:14 Jun 19, 2006
Jkt 208001
questions and will take about 10
minutes to complete. It contents deal
with the frequency of menstrual
periods, a history of polycystic ovaries,
obesity, excess facial hair and other
evidence of hyperandrogenism. Since
this is such a short telephone survey,
participants will receive no prior
notification. Informed consent will be
asked for verbally over the phone at the
time of the interview. A; participants
will be asked about their willingness to
participate in future studies if their
answers meet certain criteria. The major
objectives of future studies using this
cohort are to determine more reliable
concordance rates for PCOS in
monozygotic and diygotic twins,
establish baseline heritability estimates,
and develop hypotheses concerning
possible pathogenetic and/or
environmental factors. The findings
from this study will aid in developing:
(1) Genetic tests to identify high risk
women; (2) preventative strategies; and
(3) more effective therapies for PCOS
and related syndromes such as type 2
diabetes, obesity, idiopathic
hyperandrogenism, and male pattern
baldness. Frequency of Response: One
time. Affected Public: Individuals or
households. Type of Respondents: Adult
women. The annual reporting burden is
as follows: Estimated Number of
Respondents: 2,200; Estimated Number
of Responses Per Respondent: 1;
Average Burden Hours Per Response:
0.167; and Estimated Total Annual
Burden Hours Requested: 122 per year
for 3 more years. The annualized costs
to respondents is estimated at $2,050.38.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the fuction of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality utility and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technology
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
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Fmt 4703
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35437
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Patricia C. Chulada, Clinical Research
Scientist, Clinical Research Office,
NIEHS, P.O. Box 12233, Research
Triangle Park, NC 27709 or call non-tollfree number (919) 541–7736 or e-mail
your request, including your address to:
chulada@niehs.nih.gov.
Comments Due Date: Comments
regarding this infomation collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: March 27, 2006.
Richard A. Freed,
NIEHS Associate Director for Management.
[FR Doc. 06–5527 Filed 6–19–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Aggression Prevention
Among High-Risk Early Adolescents
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Aggression Prevention Among
High-Risk Early Adolescents Study.
Type of Information Collection Request:
EXTENSION, OMB control number
0925–0523, expiration date 9/30/2006.
Use of Information: This study will
assess the efficacy of an in-school,
group-mentoring intervention designed
to foster academic engagement and
prevent aggressive and deviant behavior
among early adolescents (approximately
ages 11–12). The primary objectives of
the study are to determine if
participation in a weekly groupmentoring program during 6th grade
E:\FR\FM\20JNN1.SGM
20JNN1
]]>Agencies
[Federal Register Volume 71, Number 118 (Tuesday, June 20, 2006)]
[Notices]
[Pages 35436-35437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9653]
[[Page 35436]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0228]
Draft Guidance for Industry and Food and Drug Administration
Staff; the Review and Inspection of Premarket Approval Applications
Under the Bioresearch Monitoring Program; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``The Review and Inspection
of Premarket Approval Applications under the Bioresearch Monitoring
Program.'' One of the performance goals, referenced in a letter to
Congress from the Secretary of Health and Human Services that
accompanied the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) legislation, includes a commitment to improve FDA's scheduling
and timeliness of preapproval inspections. This draft guidance document
is intended to assist applicants in understanding the process involved
in the bioresearch monitoring (BIMO) review of the clinical and
nonclinical information in their premarket approval application (PMA)
and the process involved in any related inspections. Premarket
notification (510(k)) submissions are not addressed in this draft
guidance because a premarket inspection is not ordinarily conducted for
510(k)s. This draft guidance is not final nor is it in effect at this
time.
DATES: Submit written or electronic comments on this draft guidance by
September 18, 2006.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``The Review and Inspection of Premarket
Approval Applications under the Bioresearch Monitoring Program'' to the
Division of Small Manufacturers, International, and Consumer Assistance
(HFZ-220), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 240-276-3151. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit written comments concerning this draft guidance 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. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Matthew J. Tarosky, Center for Devices
and Radiological Health (HFZ-310), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 240-270-0243.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250) was signed into
law. Among other things, MDUMFA authorized the collection of user fees
to improve the performance and predictability of FDA's device review
program, including PMAs. FDA, in consultation with the regulated
industry, agreed to dedicate user fees to helping the agency meet the
performance goals outlined in a letter from the Secretary of Health and
Human Services to Congress that accompanied the user fee legislation.
One such goal included a commitment to ``improve the scheduling and
timeliness of preapproval inspections.'' A portion of the user fees
collected under MDUFMA will be used to help to cover the costs
associated with the BIMO program review of the PMA and the performance
of any clinical or nonclinical inspections. FDA will monitor its BIMO
preapproval inspection program and include this information in its
annual performance report to Congress.
This draft guidance provides information about the administrative
process and timeframes within which the BIMO review of the PMA clinical
and nonclinical sections should be completed. Use of this draft
guidance should facilitate FDA's timely review and inspection of the
PMA clinical and nonclinical information and improve the coordination
of a preapproval inspection between the applicant and FDA.
II. Significance of Guidance
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 the agency's current thinking on ``The Review
and Inspection of Premarket Approval Applications under the Bioresearch
Monitoring Program.'' 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 such approach satisfies the
requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. To receive ``The Review and
Inspection of Premarket Approval Applications under the Bioresearch
Monitoring Program,'' 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 1602 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 applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-related
information. The CDRH web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft 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 USC 3501-3520) (the PRA).
The collections of information addressed in 21 CFR part 814 have been
approved by OMB under OMB Control No. 0910-0231.
V. 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
copy. Comments are to be identified with the docket number found in
brackets in the
[[Page 35437]]
heading of this document. Comments received may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9653 Filed 6-19-06; 8:45 am]
BILLING CODE 4160-01-S
