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, 58621-58622 [2017-26795]
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58621
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
No. of
responses
per
respondent
Total annual
responses
Average
burden per
response
Activity
FDA Form No.
Initial consultation ....................................
Final consultation .....................................
None ..............
3665 ...............
20
12
2
1
40
12
4
150
160
1,800
Total ..................................................
........................
........................
........................
........................
........................
1,960
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have retained the currently
approved burden estimate for this
information collection and discuss the
information collection activities below.
Initial Consultations
Initial consultations are generally a
one-time burden, although a developer
might return more than once to discuss
additional issues before submitting a
final consultation. As noted in the
guidance, FDA encourages developers to
consult early in the development phase
of their products, and as often as
necessary. Historically, firms
developing a new bioengineered plant
variety intended for food use have
generally initiated consultation with
FDA early in the process of developing
such a variety, even though there is no
legal obligation for such consultation.
These consultations have served to
make FDA aware of foods and food
ingredients before these products are
distributed commercially, and have
provided FDA with the information
necessary to address any potential
questions regarding the safety, labeling,
or regulatory status of the food or food
ingredient. As such, these consultations
have provided assistance to both
industry and the Agency in exercising
their mutual responsibilities under the
FD&C Act.
FDA estimates that its Center for
Veterinary Medicine and its Center for
Food Safety and Applied Nutrition
jointly received an average of 40 initial
consultations per year in the last 3 years
via telephone, email, or written letter.
Based on this information, we expect to
receive no more than 40 annually in the
next 3 years.
sradovich on DSK3GMQ082PROD with NOTICES
Total hours
relevant provisions of the FD&C Act.
The developer will then be in a position
to conclude any ongoing consultation
with FDA. The developer submits to
FDA a summary of the safety and
nutritional assessment that has been
conducted about the bioengineered food
that is intended to be introduced into
commercial distribution. FDA evaluates
the submission to ensure that all
potential safety and regulatory questions
have been addressed. FDA has
developed a form that prompts a
developer to include certain elements in
the final consultation in a standard
format: Form FDA 3665 entitled, ‘‘Final
Consultation for Food Derived From a
New Plant Variety (Biotechnology Final
Consultation).’’ The form, and elements
that would be prepared as attachments
to the form, can be submitted in
electronic format.
We base our estimate of the average
time to prepare a submission on
informal contact with firms that made
one or more biotechnology consultation
submission under the voluntary
biotechnology consultation process. As
such, we estimate the average time to
prepare a submission for final
consultation to be 150 hours.
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26794 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
18:53 Dec 12, 2017
Jkt 244001
PO 00000
Food and Drug Administration
[Docket No. FDA–2014–N–0345]
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 January 12,
2018.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0695. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7729, PRAStaff@
fda.hhs.gov.
Final Consultations
Final consultations are a one-time
burden. At some stage in the process of
research and development, a developer
will have accumulated the information
that the developer believes is adequate
to ensure that food derived from the
new plant variety is safe and that it
demonstrates compliance with the
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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13DEN1
58622
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
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 0910–0695—
Extension
This information collection supports
Agency outreach efforts. 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 in-depth interviews,
general public focus group interviews,
intercept interviews, self-administered
surveys, gatekeeper surveys, and
professional clinician focus group
interviews, all on a voluntary basis. 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 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. Annually, FDA
projects about 45 communication
studies using the variety of test methods
listed in this document. FDA is
requesting an extension of these burden
hours so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of June 19,
2017 (82 FR 27840), we published a 60-
day notice requesting public comment
on the proposed extension of the
collection of information. One comment
was received requesting that FDA
publish an annual list of its planned
drug product communication studies
and strive to reflect an overall work
plan. The comment also noted the rather
broad topic areas included in the
information collection and suggested
that perhaps additional notice regarding
individual studies would allow for more
meaningful feedback on whether that
particular study would be necessary.
FDA appreciates this comment. In
determining which drug product
communications it will undertake, we
first consider those we believe will best
address current or immediate public
health issues. We also note that, in
accordance with the PRA, any proposed
study under this information collection
request must first be submitted to and
approved by OMB to determine whether
it falls within the scope of the
collection. At the same time, as
resources are available, we will make
every effort to communicate to our
stakeholders anticipated studies so that
ongoing or related research can be
coordinated.
We therefore estimate the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews/Surveys .....................................................
1 There
19,822
Average
burden per
response
(in hours)
Total annual
responses
1
19,822
0.24 (14 minutes) ....
Total hours
4,757
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2017–26795 Filed 12–12–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
Program, Division of Extramural Activities,
Room 3G62A, National Institute of Health,
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20899–823, (240) 669–5081,
ecohen@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: January 17, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Eleazar Cohen, Ph.D.,
Scientific Review Officer, Scientific Review
Dated: December 6, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
PO 00000
Frm 00035
Fmt 4703
Sfmt 9990
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2017–26799 Filed 12–12–17; 8:45 am]
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]]>Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58621-58622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0345]
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 January
12, 2018.
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 emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0695.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7729,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 58622]]
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 0910-0695--Extension
This information collection supports Agency outreach efforts.
Testing of communication messages in advance of a communication
campaign provides an important role in improving FDA communications as
they allow for an in-depth understanding of individuals' attitudes,
beliefs, motivations, and feelings. The methods to be employed include
individual in-depth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and professional clinician focus group interviews, all on a voluntary
basis. 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 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. Annually,
FDA projects about 45 communication studies using the variety of test
methods listed in this document. FDA is requesting an extension of
these burden hours so as not to restrict the Agency's ability to gather
information on public sentiment for its proposals in its regulatory and
communications programs.
In the Federal Register of June 19, 2017 (82 FR 27840), we
published a 60-day notice requesting public comment on the proposed
extension of the collection of information. One comment was received
requesting that FDA publish an annual list of its planned drug product
communication studies and strive to reflect an overall work plan. The
comment also noted the rather broad topic areas included in the
information collection and suggested that perhaps additional notice
regarding individual studies would allow for more meaningful feedback
on whether that particular study would be necessary. FDA appreciates
this comment. In determining which drug product communications it will
undertake, we first consider those we believe will best address current
or immediate public health issues. We also note that, in accordance
with the PRA, any proposed study under this information collection
request must first be submitted to and approved by OMB to determine
whether it falls within the scope of the collection. At the same time,
as resources are available, we will make every effort to communicate to
our stakeholders anticipated studies so that ongoing or related
research can be coordinated.
We therefore estimate the burden of this collection of information
as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys........................... 19,822 1 19,822 0.24 (14 minutes)........................ 4,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26795 Filed 12-12-17; 8:45 am]
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