Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability, 11118-11119 [E9-5650]
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Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
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Guidance documents are also available
at https://www.regulations.gov or the
CBER Internet site at https://
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IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: User Fees and Refunds for
Premarket Approval Applications.
Description: Section 738 of the act
requires the payment of user fees for
devices subject to premarket approval
(PMA) under section 515 of the act (21
U.S.C. 360e). Section 738(j) of the act
allows for refunds of these fees in
certain circumstances. This draft
guidance document describes
requirements associated with user fees
and FDA’s recommendation for the kind
of information to include in a request
for a refund.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Federal Food, Drug, and Cosmetic Act
No. of
Respondents
738(j)
1There
Annual Frequency
per Response
17
Total Annual
Responses
1
Hours per
Response
17
Total Hours
0.5
9
are no capital costs or operating and maintenance costs associated with this collection of information.
The industry-wide burden estimate is
based on an FDA actual average fiscal
year (FY) annual rate of receipt of 17
refund requests, using FY 2005 through
2007 data.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 814, subparts B and E have
been approved under OMB control
number 0910–0231.
Dated: March 4, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E9–5543 Filed 3–13–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0052]
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 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.
VerDate Nov<24>2008
15:38 Mar 13, 2009
Jkt 217001
Draft Guidance for Industry on
Documenting Statistical Analysis
Programs and Data Files; 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 #197 entitled ‘‘Draft Guidance
for Industry on Documenting Statistical
Analysis Programs and Data Files.’’ The
purpose of this draft guidance is to
simplify the preparation and evaluation
of submissions in support of new
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
animal drug applications by providing a
uniform system for documenting
statistical analysis programs and data
files.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by June 1, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the 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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
E:\FR\FM\16MRN1.SGM
16MRN1
Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Robert Abugov, Center for Veterinary
Medicine (HFV–105), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8168,
Robert.abugov@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cvm or https://
www.regulations.gov.
I. Background
FDA is announcing the availability of
a draft guidance for industry #197
entitled ‘‘Draft Guidance for Industry on
Documenting Statistical Analysis
Programs and Data Files.’’ This draft
guidance provides recommendations to
study statisticians for documenting
statistical analyses and data files
submitted to the Center for Veterinary
Medicine (CVM) for the evaluation of
safety and effectiveness in new animal
drug applications. These
recommendations are intended to
reduce the number of revisions that may
be required for CVM to effectively
review statistical analyses and to
simplify submission preparation by
providing a uniform documentation
system.
II. Significance of Guidance
This level 1 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 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 such approach
satisfies the requirements of the
applicable statutes and regulations.
III. 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 U.S.C. 3501–3520). The collections
of information in 21 CFR part 514 have
been approved under OMB control no.
0910–0032.
IV. 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. Received
comments may be seen in the Division
VerDate Nov<24>2008
15:38 Mar 13, 2009
Jkt 217001
Dated: March 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–5650 Filed 3–13–09; 8:45 am]
11119
registration fees cover the cost of
facilities, materials, and breaks. Seats
are limited; please submit your
registration as soon as possible. Course
space will be filled in order of receipt
of registration. Those accepted into the
course will receive confirmation.
Registration will close after the course is
filled. Registration at the site is not
guaranteed but may be possible on a
space available basis on the day of the
public workshop beginning at 7:30 a.m.
The cost of registration follows:
BILLING CODE 4160–01–S
COST OF REGISTRATION
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Affiliation
Fee
Government (AFDO/North Central AFDO Member)
$395.00
[Docket No. FDA–2009–N–0664]
Government (Non-Member)
$495.00
Industry Exchange Workshop on Food
and Drug Administration Drug and
Device Requirements; Public
Workshop
Non-Government (AFDO/
NCAFDO Member)
$450.00
Non-Government (Non-Member)
$550.00
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Chicago District,
in cosponsorship with the Association
of Food and Drug Officials (AFDO), is
announcing a public workshop entitled
‘‘Drugs and Devices—Promoting and
Protecting the Public Health Through
Risk Management and Product Cycle
Improvement.’’ This 2-day public
workshop is intended to provide
information about FDA drug and device
regulation to the regulated industry.
Date and Time: The public workshop
will be held on Monday, June 8, 2009,
from 10:20 a.m. to 5 p.m. and Tuesday,
June 9, 2009, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Doubletree Hotel
Chicago—Oakbrook, 1909 Spring Rd.,
Oak Brook, IL 60523, 800–222–TREE,
800–222–8733, or 630–472–6000, FAX:
630–573–1909.
Attendees are responsible for their
own accommodations. To make
reservations at the Doubletree Hotel
Chicago—OakBrook, at the reduced
conference rate, contact the Doubletree
Hotel Chicago—OakBrook before May 5,
2009, citing meeting code ‘‘AFDO
Conference’’.
Contact: William Weissinger, Food
and Drug Administration, 550 W.
Jackson Blvd., 15th Fl., Chicago, IL
60661, 312–596–4210, FAX: 312–596–
4242, e-mail:
William.weissinger@fda.hhs.gov.
Registration: You are encouraged to
register by May 12, 2009. The AFDO
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
To be added to registration fee
for workshop registration
postmarked after May
12,2009
$75.00
If you need special accommodations
due to a disability, please contact
William Weissinger at least 7 days in
advance of the workshop.
Registration instructions: To register,
please submit your name, affiliation,
mailing address, phone, fax number,
and e-mail, along with a check or money
order payable to ‘‘AFDO.’’ Please mail
your payment to: AFDO, 2550 Kingston
Rd., suite 311, York, PA 17402. To
register via the Internet, go to
www.afdo.org. (FDA has verified the
Web site address, but is not responsible
for subsequent changes to the Web site
after this document publishes in the
Federal Register).
The registrar will also accept payment
by major credit cards (VISA/MasterCard
only). For more information on the
meeting, or for questions on registration,
contact AFDO, 717–757–2888, FAX:
717–755–8089, or e-mail:
afdo@afdo.org.
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide FDA-regulated
drug and device entities with
information on a number of topics
concerning FDA requirements related to
the production and marketing of drugs
and/or devices. Topics for discussion
include the following:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 74, Number 49 (Monday, March 16, 2009)]
[Notices]
[Pages 11118-11119]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0052]
Draft Guidance for Industry on Documenting Statistical Analysis
Programs and Data Files; 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 197 entitled
``Draft Guidance for Industry on Documenting Statistical Analysis
Programs and Data Files.'' The purpose of this draft guidance is to
simplify the preparation and evaluation of submissions in support of
new animal drug applications by providing a uniform system for
documenting statistical analysis programs and data files.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by June 1, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests.
Submit written comments on the 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.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
[[Page 11119]]
FOR FURTHER INFORMATION CONTACT: Robert Abugov, Center for Veterinary
Medicine (HFV-105), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8168, Robert.abugov@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
197 entitled ``Draft Guidance for Industry on Documenting
Statistical Analysis Programs and Data Files.'' This draft guidance
provides recommendations to study statisticians for documenting
statistical analyses and data files submitted to the Center for
Veterinary Medicine (CVM) for the evaluation of safety and
effectiveness in new animal drug applications. These recommendations
are intended to reduce the number of revisions that may be required for
CVM to effectively review statistical analyses and to simplify
submission preparation by providing a uniform documentation system.
II. Significance of Guidance
This level 1 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 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 such approach satisfies the requirements of the applicable
statutes and regulations.
III. 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 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control no. 0910-0032.
IV. 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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/cvm or https://www.regulations.gov.
Dated: March 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5650 Filed 3-13-09; 8:45 am]
BILLING CODE 4160-01-S
