International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries; Availability, 53021-53022 [05-17597]
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Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: August 22, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–17602 Filed 9–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0324]
International Conference on
Harmonisation; Draft Guidance on M5
Data Elements and Standards for Drug
Dictionaries; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘M5 Data Elements and Standards for
Drug Dictionaries.’’ The draft guidance
was prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance describes the data
elements and standards that ICH
recommends be made available to
interested parties to assist in the
development and maintenance of drug
dictionaries. The draft guidance is
intended to facilitate the exchange and
practical use of medicinal product
information at the international level,
such as with postmarketing safety
reporting.
DATES: Submit written or electronic
comments on the draft guidance by
October 21, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: 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on the draft guidance to the Division of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.fda.gov/dockets/ecomments.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training, and
VerDate Aug<18>2005
13:21 Sep 02, 2005
Jkt 205001
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. The draft
guidance may also be obtained by mail
by calling the CBER Voice Information
System at 1–800–835–4709 or 301–827–
1800. Send two self-addressed adhesive
labels to assist the office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Randy Levin,
Center for Drug Evaluation and
Research (HFD–001), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–
827–7784; or Ann Schwartz, Center
for Biologics Evaluation and
Research (HFM–475), Food and
Drug Administration, 1401
Rockville Pike, rm. 300N, Rockville,
MD 20832, 301–827–3070.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
53021
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of ICH’s
sponsors and IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In May 2005, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘M5 Data Elements and
Standards for Drug Dictionaries’’ should
be made available for public comment.
The draft guidance is the product of the
M5 Expert Working Group of the ICH.
Comments about this draft will be
considered by FDA and the M5 expert
working group.
The draft guidance describes the data
elements that ICH recommends be made
available to interested parties to assist in
the development and maintenance of
drug dictionaries. The draft guidance
outlines each data element and provides
recommended standards for the data
elements. The draft guidance addresses
medicinal products (drugs and
biologics) and is intended to accomplish
the following goals:
• Improve the exchange of medicinal
product information,
• Improve consistency in evaluating
and comparing medicinal products for
postmarketing surveillance activities,
• Provide consistent terminology for
the health care community, and
• Reduce administrative burdens for
the pharmaceutical industry when
complying with different regional
regulatory requirements.
The draft guidance refers to approved
medicinal products. The draft guidance
does not apply to homeopathic
medicinal products or investigational
medicinal products. The draft guidance
does not cover the establishment and
maintenance of a drug dictionary.
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 M5 data elements and standards for
drug dictionaries. 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.
E:\FR\FM\06SEN1.SGM
06SEN1
53022
Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. 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/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/reading.htm.
Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17597 Filed 9–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Notice and request for
comments.
ACTION:
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed information
collections. In accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3506(c)(2)(A)), this notice seeks
comments concerning information
required by FEMA to amend or revise
National Flood Insurance Program Maps
to remove certain property from the 1percent annual chance floodplain.
With the
passage of the Flood Disaster Protection
Act of 1973, an owner of a structure,
with a federally backed mortgage,
located in the 1-percent annual chance
floodplain, was required to purchase
federal flood insurance. This was in
response to the escalating damage
caused by flooding and the
unavailability of flood insurance from
commercial insurance companies. As
part of this effort, FEMA mapped the 1percent annual chance floodplain in
communities. However, due to scale
limitations, individual structures that
may be above the base flood cannot
always be shown as being out of the 1percent annual chance floodplain.
FEMA will issue a Letter of Map
Amendment (LOMA) or a Letter of Map
Revision—Based on Fill (LOMR–F) to
waive the Federal requirement for flood
insurance when data is submitted to
show that the property or structure is
‘‘reasonably safe from flooding’’ and at
or above the elevation of the base flood.
SUPPLEMENTARY INFORMATION.
Collection of Information
Title: Right to Submit Technical or
Scientific Data to Correct Mapping
Deficiencies.
Type of Information Collection:
Revision of a Currently Approved
Collection.
OMB Number: 1660–0015.
Form Numbers: FEMA Forms 81–87,
81–87A, 81–87B.
Abstract: The certification forms
(referred to as MT–1 series forms) are
designed to assist requesters in
gathering information that FEMA needs
to determine whether a certain property
is likely to be flooded during the flood
event that has a 1-percent annual
chance of being equaled or exceeded in
any given year (base flood). FEMA Form
81–87, Property Information, describes
the location of the property, what is
being requested, and what data are
required to support the request. FEMA
Form 81–87A, Elevation Information,
indicates what the Base (1-percent
annual chance) Flood Elevation (BFE)
for the property is, how the BFE was
determined, the lowest ground elevation
on the property, and/or the elevation of
the lowest adjacent grade to any
structures on the property. This
information is required in order for
FEMA to determine if the property that
the requester would like removed from
the SFHA FEMA Form 81–87B,
Community Acknowledgment, requires
that a community official certify that the
request complies with minimum
floodplain management criteria
specified in 44 CFR 60.3, as per NFIP
regulations 44 CFR 65.5(a)(4).
Estimated Total Annual Burden
Hours: 57,300.
ANNUAL BURDEN HOURS
Number of
respondents
(A)
Project/activity (survey, form(s), focus group, etc.)
Frequency of
responses
(B)
Burden hours
per respondent
(C)
Annual
responses
(A × B)
Total annual
burden hours
(A × B × C)
81–87 ................................................................................
81–87A ..............................................................................
81–87B ..............................................................................
18,272
18,272
3,389
Annual (1) .........
Annual (1) .........
Annual (1) .........
1.63
1.25
1.38
18,272
18,272
3,389
29,783
22,840
4,677
Total ...........................................................................
39,933
...........................
4.26
39,933
57,300
Estimated Cost. Cost to respondents is
estimated to be $1,325,597 annually,
while the cost to the Federal
Government is estimated to be $94,300
annually.
Comments: Written comments are
solicited to (a) evaluate whether the
proposed data collection is necessary for
the proper performance of the agency,
including whether the information shall
have practical utility; (b) evaluate the
VerDate Aug<18>2005
13:21 Sep 02, 2005
Jkt 205001
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses. Comments should be
received within 60 days of the date of
this notice.
ADDRESSES: Interested persons should
submit written comments to Chief,
Records Management Section,
Information Resources Management
Branch, Information Technology
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 70, Number 171 (Tuesday, September 6, 2005)]
[Notices]
[Pages 53021-53022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17597]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0324]
International Conference on Harmonisation; Draft Guidance on M5
Data Elements and Standards for Drug Dictionaries; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``M5 Data Elements and
Standards for Drug Dictionaries.'' The draft guidance was prepared
under the auspices of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH). The draft guidance describes the data elements and standards
that ICH recommends be made available to interested parties to assist
in the development and maintenance of drug dictionaries. The draft
guidance is intended to facilitate the exchange and practical use of
medicinal product information at the international level, such as with
postmarketing safety reporting.
DATES: Submit written or electronic comments on the draft guidance by
October 21, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: 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.fda.gov/dockets/ecomments. Submit written
requests for single copies of the draft guidance to the Division of
Drug Information (HFD-240), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857;
or the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
draft guidance may also be obtained by mail by calling the CBER Voice
Information System at 1-800-835-4709 or 301-827-1800. Send two self-
addressed adhesive labels to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Randy Levin, Center for Drug Evaluation and
Research (HFD-001), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7784; or Ann Schwartz, Center for
Biologics Evaluation and Research (HFM-475), Food and Drug
Administration, 1401 Rockville Pike, rm. 300N, Rockville, MD 20832,
301-827-3070.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
ICH's sponsors and IFPMA, as well as observers from the World Health
Organization, Health Canada, and the European Free Trade Area.
In May 2005, the ICH Steering Committee agreed that a draft
guidance entitled ``M5 Data Elements and Standards for Drug
Dictionaries'' should be made available for public comment. The draft
guidance is the product of the M5 Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the M5 expert
working group.
The draft guidance describes the data elements that ICH recommends
be made available to interested parties to assist in the development
and maintenance of drug dictionaries. The draft guidance outlines each
data element and provides recommended standards for the data elements.
The draft guidance addresses medicinal products (drugs and biologics)
and is intended to accomplish the following goals:
Improve the exchange of medicinal product information,
Improve consistency in evaluating and comparing medicinal
products for postmarketing surveillance activities,
Provide consistent terminology for the health care
community, and
Reduce administrative burdens for the pharmaceutical
industry when complying with different regional regulatory
requirements.
The draft guidance refers to approved medicinal products. The draft
guidance does not apply to homeopathic medicinal products or
investigational medicinal products. The draft guidance does not cover
the establishment and maintenance of a drug dictionary.
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 M5 data
elements and standards for drug dictionaries. 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.
[[Page 53022]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
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/ohrms/dockets/default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://www.fda.gov/cber/reading.htm.
Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17597 Filed 9-2-05; 8:45 am]
BILLING CODE 4160-01-S
