82 FR 58621 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 238 (December 13, 2017)

Page Range		58621-58622
FR Document		2017-26795

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.

Federal Register, Volume 82 Issue 238 (Wednesday, December 13, 2017)

[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58621-58622]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26795]


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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]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices 58621

FDA estimates the burden of this
collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of Average
No. of responses Total annual
Activity FDA Form No. burden per Total hours
respondents per responses response
respondent

Initial consultation .................................... None .............. 20 2 40 4 160
Final consultation ..................................... 3665 ............... 12 1 12 150 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 relevant provisions of the FD&C Act. DEPARTMENT OF HEALTH AND
approved burden estimate for this The developer will then be in a position HUMAN SERVICES
information collection and discuss the to conclude any ongoing consultation
information collection activities below. with FDA. The developer submits to Food and Drug Administration
Initial Consultations FDA a summary of the safety and
nutritional assessment that has been [Docket No. FDA–2014–N–0345]
Initial consultations are generally a conducted about the bioengineered food
one-time burden, although a developer Agency Information Collection
that is intended to be introduced into
might return more than once to discuss Activities; Submission for Office of
commercial distribution. FDA evaluates
additional issues before submitting a Management and Budget Review;
final consultation. As noted in the the submission to ensure that all Comment Request; Data To Support
guidance, FDA encourages developers to potential safety and regulatory questions Drug Product Communications as
consult early in the development phase have been addressed. FDA has Used by the Food and Drug
of their products, and as often as developed a form that prompts a Administration
necessary. Historically, firms developer to include certain elements in
developing a new bioengineered plant the final consultation in a standard AGENCY: Food and Drug Administration,
variety intended for food use have format: Form FDA 3665 entitled, ‘‘Final HHS.
generally initiated consultation with Consultation for Food Derived From a ACTION: Notice.
FDA early in the process of developing New Plant Variety (Biotechnology Final
Consultation).’’ The form, and elements SUMMARY: The Food and Drug
such a variety, even though there is no
that would be prepared as attachments Administration (FDA) is announcing
legal obligation for such consultation.
that a proposed collection of
These consultations have served to to the form, can be submitted in
information has been submitted to the
make FDA aware of foods and food electronic format.
Office of Management and Budget
ingredients before these products are We base our estimate of the average (OMB) for review and clearance under
distributed commercially, and have time to prepare a submission on the Paperwork Reduction Act of 1995.
provided FDA with the information informal contact with firms that made
necessary to address any potential DATES: Fax written comments on the
one or more biotechnology consultation collection of information by January 12,
questions regarding the safety, labeling,
submission under the voluntary 2018.
or regulatory status of the food or food
ingredient. As such, these consultations biotechnology consultation process. As ADDRESSES: To ensure that comments on
have provided assistance to both such, we estimate the average time to the information collection are received,
industry and the Agency in exercising prepare a submission for final OMB recommends that written
their mutual responsibilities under the consultation to be 150 hours. comments be faxed to the Office of
FD&C Act. Dated: December 5, 2017. Information and Regulatory Affairs,
FDA estimates that its Center for Leslie Kux, OMB, Attn: FDA Desk Officer, Fax: 202–
Veterinary Medicine and its Center for 395–7285, or emailed to oira_
Associate Commissioner for Policy.
Food Safety and Applied Nutrition submission@omb.eop.gov. All
[FR Doc. 2017–26794 Filed 12–12–17; 8:45 am]
jointly received an average of 40 initial comments should be identified with the
consultations per year in the last 3 years BILLING CODE 4164–01–P OMB control number 0910–0695. Also
via telephone, email, or written letter. include the FDA docket number found
Based on this information, we expect to in brackets in the heading of this
receive no more than 40 annually in the document.
next 3 years. FOR FURTHER INFORMATION CONTACT:
Final Consultations Domini Bean, Office of Operations,
Final consultations are a one-time Food and Drug Administration, Three
sradovich on DSK3GMQ082PROD with NOTICES

burden. At some stage in the process of White Flint North, 10A–12M, 11601
research and development, a developer Landsdown St., North Bethesda, MD
will have accumulated the information 20852, 301–796–7729, PRAStaff@
that the developer believes is adequate fda.hhs.gov.
to ensure that food derived from the SUPPLEMENTARY INFORMATION: In
new plant variety is safe and that it compliance with 44 U.S.C. 3507, FDA
demonstrates compliance with the has submitted the following proposed

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58622 Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices

collection of information to OMB for communicating with their intended day notice requesting public comment
review and clearance. audiences. on the proposed extension of the
FDA will use these methods to test collection of information. One comment
Data To Support Drug Product and refine its ideas and to help develop
Communications as Used by the Food was received requesting that FDA
messages and other communications but publish an annual list of its planned
and Drug Administration will generally conduct further research drug product communication studies
OMB Control Number 0910–0695— before making important decisions, such and strive to reflect an overall work
Extension as adopting new policies and allocating plan. The comment also noted the rather
or redirecting significant resources to
This information collection supports broad topic areas included in the
support these policies. FDA will use
Agency outreach efforts. Testing of information collection and suggested
this mechanism to test messages about
communication messages in advance of regulated drug products on a variety of that perhaps additional notice regarding
a communication campaign provides an subjects related to consumer, patient, or individual studies would allow for more
important role in improving FDA health care professional perceptions and meaningful feedback on whether that
communications as they allow for an in- about use of drug products and related particular study would be necessary.
depth understanding of individuals’ materials, including but not limited to, FDA appreciates this comment. In
attitudes, beliefs, motivations, and direct-to-consumer prescription drug determining which drug product
feelings. The methods to be employed promotion, physician labeling of communications it will undertake, we
include individual in-depth interviews, prescription drugs, medication guides, first consider those we believe will best
general public focus group interviews, over-the-counter drug labeling, address current or immediate public
intercept interviews, self-administered emerging risk communications, patient health issues. We also note that, in
surveys, gatekeeper surveys, and labeling, online sale of medical accordance with the PRA, any proposed
professional clinician focus group products, and consumer and study under this information collection
interviews, all on a voluntary basis. The professional education. Annually, FDA request must first be submitted to and
methods to be used serve the narrowly projects about 45 communication approved by OMB to determine whether
defined need for direct and informal studies using the variety of test methods it falls within the scope of the
opinion on a specific topic and, as a listed in this document. FDA is collection. At the same time, as
qualitative research tool, have two major requesting an extension of these burden resources are available, we will make
purposes: To obtain information that is hours so as not to restrict the Agency’s every effort to communicate to our
useful for developing variables and ability to gather information on public
measures for formulating the basic stakeholders anticipated studies so that
sentiment for its proposals in its
objectives of risk communication ongoing or related research can be
regulatory and communications
campaigns, and to assess the potential programs. coordinated.
effectiveness of messages and materials In the Federal Register of June 19, We therefore estimate the burden of
in reaching and successfully 2017 (82 FR 27840), we published a 60- this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
Activity responses per Total hours
respondents responses response
respondent (in hours)

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. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program, Division of Extramural Activities,
Leslie Kux, as amended. The grant applications and Room 3G62A, National Institute of Health,
Associate Commissioner for Policy. the discussions could disclose NIAID, 5601 Fishers Lane, MSC 9823,
[FR Doc. 2017–26795 Filed 12–12–17; 8:45 am] confidential trade secrets or commercial Bethesda, MD 20899–823, (240) 669–5081,
property such as patentable material, ecohen@niaid.nih.gov.
BILLING CODE 4164–01–P
and personal information concerning (Catalogue of Federal Domestic Assistance
individuals associated with the grant Program Nos. 93.855, Allergy, Immunology,
DEPARTMENT OF HEALTH AND applications, the disclosure of which and Transplantation Research; 93.856,
HUMAN SERVICES would constitute a clearly unwarranted Microbiology and Infectious Diseases
invasion of personal privacy. Research, National Institutes of Health, HHS)
National Institutes of Health Name of Committee: National Institute of Dated: December 6, 2017.
Allergy and Infectious Diseases Special
National Institute of Allergy and Natasha M. Copeland,
Emphasis Panel; NIAID Investigator Initiated
Infectious Diseases; Notice of Closed Program Project Applications (P01). Program Analyst, Office of Federal Advisory
Meeting Date: January 17, 2018. Committee Policy.
sradovich on DSK3GMQ082PROD with NOTICES

Time: 11:00 a.m. to 4:00 p.m. [FR Doc. 2017–26799 Filed 12–12–17; 8:45 am]
Pursuant to section 10(d) of the
Agenda: To review and evaluate grant BILLING CODE 4140–01–P
Federal Advisory Committee Act, as
applications.
amended, notice is hereby given of the Place: National Institutes of Health, 5601
following meeting. Fishers Lane, Rockville, MD 20892,
The meeting will be closed to the (Telephone Conference Call).
public in accordance with the Contact Person: Eleazar Cohen, Ph.D.,
provisions set forth in sections Scientific Review Officer, Scientific Review

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Document Created: 2017-12-13 01:23:33
Document Modified: 2017-12-13 01:23:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by January 12, 2018.
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]
FR Citation		82 FR 58621

82 FR 58621 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 238 (December 13, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration