Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications, as Used by the Food and Drug Administration, 32217-32218 [2011-13812]
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Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
and in foreign languages or in the older,
classical literature where it is not
available on computerized literature
databases or in the major scientific
reference databases, such as the
National Library of Medicine’s literature
database, all of which increases the time
of obtaining substantiation.
In the Federal Register of January 6,
2000 (65 FR 1000), FDA published a
final rule on statements made for dietary
supplements concerning the effect of the
product on the structure or function of
the body. FDA estimated that there were
29,000 dietary supplement products
marketed in the U.S. (65 FR 1000 at
1045). Assuming that the flow of new
products is 10 percent per year, then
2,900 new dietary supplement products
will come on the market each year. The
structure/function final rule estimated
that about 69 percent of dietary
supplements have a claim on their
labels, most probably a structure/
function claim (65 FR 1000 at 1046).
Therefore, we assume that supplement
manufacturers will need time to
assemble the evidence to substantiate
each of the 2,001 claims (2,900 × 69
percent) made each year. If we assume
that the 2,001 claims are equally likely
to be pre-existing widely established
claims, novel claims, or pre-existing
claims that are not widely established,
then we can expect 667 of each of these
types of claims to be substantiated per
year. Table 1 of this document shows
that the annual burden hours associated
with assembling evidence for claims is
189,428 (the sum of 667 × 44 hours, 667
× 120 hours, and 667 × 120 hours).
Dated: May 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13813 Filed 6–2–11; 8:45 am]
jlentini on DSK4TPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0067]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Drug Product Communications, as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 5,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Data to Support Drug Product
Communications, as Used by the Food
and Drug Administration.’’ Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Data To Support Drug Product
Communications, as Used by the Food
and Drug Administration—(OMB
Control Number 0910–NEW)
Testing of communication messages
in advance of a communication
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32217
campaign provides an important role in
improving FDA communications as they
allow for an indepth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. The methods
to be employed include individual
indepth interviews, general public focus
group interviews, intercept interviews,
self-administered surveys, gatekeeper
surveys, and professional clinician
focus group interviews. The methods to
be used serve the narrowly defined need
for direct and informal opinion on a
specific topic and, as a qualitative
research tool, have two major purposes:
• To obtain information that is useful
for developing variables and measures
for formulating the basic objectives of
risk communication campaigns and
• To assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences.
FDA will use these methods to test
and refine its ideas and to help develop
messages and other communications but
will generally conduct further research
before making important decisions, such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
FDA’s Center for Drug Evaluation and
Research, Center for Biologics
Evaluation and Research, Office of the
Commissioner, and any other Centers or
Offices will use this mechanism to test
messages about regulated drug products
on a variety of subjects related to
consumer, patient, or health care
professional perceptions and about use
of drug products and related materials,
including but not limited to, direct-toconsumer prescription drug promotion,
physician labeling of prescription drugs,
Medication Guides, over-the-counter
drug labeling, emerging risk
communications, patient labeling,
online sale of medical products, and
consumer and professional education.
In the Federal Register of February 8,
2011 (76 FR 6800), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03JNN1.SGM
03JNN1
32218
Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Interviews/Surveys ...............................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Total hours
19,822
1
19,822
14/60
4,757
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
Annually, FDA projects about 45
communication studies using the
variety of test methods listed previously
in this document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13812 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2003–D–0433] (formerly
FDA–2003D–0474)
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Draft Revised Guidance for Industry on
‘‘Studies To Evaluate the Safety of
Residues of Veterinary Drugs in
Human Food: General Approach To
Establish a Microbiological ADI’’ (VICH
GL–36(R)); Request for Comments;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability for comments of a draft
revised guidance for industry (#159)
entitled ‘‘Studies to Evaluate the Safety
of Residues of Veterinary Drugs in
Human Food: General Approach to
Establish a Microbiological ADI’’ (VICH
GL36(R)). This draft revised guidance,
which updates a final guidance on the
same topic for which a notice of
availability was published in the
Federal Register of February 11, 2005,
has been developed for veterinary use
by the International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:49 Jun 02, 2011
Jkt 223001
This draft revised VICH guidance was
revised to include Appendix D—
Supplement to Section 2 Regarding the
Determination of the Fraction of Oral
Dose Available to Microorganisms. This
draft VICH guidance document is
intended to provide guidance for
assessing the human food safety of
residues from veterinary antimicrobial
drugs with regard to effects on the
human intestinal flora.
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
revised guidance before it begins work
on the final version of the revised
guidance, submit either electronic or
written comments on the draft revised
guidance by August 2, 2011.
ADDRESSES: Submit written requests for
single copies of the draft revised
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 request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft revised
guidance document.
Submit electronic comments on the
draft revised guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Silvia A. Pineiro, Center for Veterinary
Medicine, (HFV–157), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–276–8227,
Silvia.Pineiro@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
PO 00000
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harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Approval of
Pharmaceuticals for Human Use (ICH)
for several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH) is
a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission,
European Medicines Evaluation Agency,
European Federation of Animal Health,
Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S.
Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary
Pharmaceutical Association, the
Japanese Association of Veterinary
Biologics, and the Japanese Ministry of
Agriculture, Forestry and Fisheries.
Four observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, and one representative from the
industry of Canada. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32217-32218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0067]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Data To Support Drug
Product Communications, as Used by the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July 5,
2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Data to Support Drug Product Communications, as Used by the
Food and Drug Administration.'' Also include the FDA docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Data To Support Drug Product Communications, as Used by the Food and
Drug Administration--(OMB Control Number 0910-NEW)
Testing of communication messages in advance of a communication
campaign provides an important role in improving FDA communications as
they allow for an indepth understanding of individuals' attitudes,
beliefs, motivations, and feelings. The methods to be employed include
individual indepth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and professional clinician focus group interviews. The methods to be
used serve the narrowly defined need for direct and informal opinion on
a specific topic and, as a qualitative research tool, have two major
purposes:
To obtain information that is useful for developing
variables and measures for formulating the basic objectives of risk
communication campaigns and
To assess the potential effectiveness of messages and
materials in reaching and successfully communicating with their
intended audiences.
FDA will use these methods to test and refine its ideas and to help
develop messages and other communications but will generally conduct
further research before making important decisions, such as adopting
new policies and allocating or redirecting significant resources to
support these policies.
FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the Commissioner, and any other
Centers or Offices will use this mechanism to test messages about
regulated drug products on a variety of subjects related to consumer,
patient, or health care professional perceptions and about use of drug
products and related materials, including but not limited to, direct-
to-consumer prescription drug promotion, physician labeling of
prescription drugs, Medication Guides, over-the-counter drug labeling,
emerging risk communications, patient labeling, online sale of medical
products, and consumer and professional education.
In the Federal Register of February 8, 2011 (76 FR 6800), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 32218]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Number of responses per Total annual per response Total hours
respondents respondent responses (in hours) \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys................................................. 19,822 1 19,822 14/60 4,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of minutes per response]/60''.
Annually, FDA projects about 45 communication studies using the
variety of test methods listed previously in this document. FDA is
requesting this burden so as not to restrict the Agency's ability to
gather information on public sentiment for its proposals in its
regulatory and communications programs.
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13812 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P
