82 FR 27492 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 114 (June 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 114 (June 15, 2017)
| Page Range | 27492-27493 | |
| FR Document | 2017-12446 |
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)] [Notices] [Pages 27492-27493] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12446] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2683] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research 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 17, 2017. 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--NEW and ``Data to Support Social and Behavioral Research 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: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@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 Social and Behavioral Research as Used by the Food and Drug Administration--OMB Control Number 0910--NEW Understanding patients, consumers, and health care professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decisionmaking processes and communications impacting various stakeholders. The methods to be employed to achieve these goals include individual indepth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and 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 and quantitative research tool, and have two major purposes: (1) To obtain information that is useful for developing variables and measures for formulating the basic objectives of social and behavioral research; and (2) To assess the potential effectiveness of FDA communications, behavioral interventions, and other materials in reaching and successfully communicating and addressing behavioral change with their intended audiences. FDA will use these methods to test and refine its ideas and to help develop communication and behavioral strategies research, 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 potentially other Agency components will use this mechanism to test communications and social and behavioral methods about regulated drug products on a variety of subjects related to consumer, patient, or health care professional perceptions, beliefs, attitudes, behaviors, and use of [[Page 27493]] drug and biological products and related materials, including, but not limited to, social and behavioral research, decisionmaking processes, and communication and behavioral change strategies. Annually, FDA estimates about 45 social and behavioral studies using the variety of test methods listed 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. In the Federal Register of September 19, 2016 (81 FR 64166), FDA published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the notice. FDA estimates 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 Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Interviews/Surveys........................... 2,520 14.6 36,792 0.25 (15 minutes)........................ 9,198 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12446 Filed 6-14-17; 8:45 am] BILLING CODE 4164-01-P
![27492 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
With respect to the following collection of information on Federal preemption of State food
collection of information, FDA invites respondents, including through the use labeling and standard-of-identity
comments on these topics: (1) Whether of automated collection techniques, requirements. Section 100.1(d) (21 CFR
the proposed collection of information when appropriate, and other forms of 100.1(d)) sets forth the information a
is necessary for the proper performance information technology. State is required to submit in such a
of FDA’s functions, including whether petition. The information required
the information will have practical State Petitions for Exemption From under § 100.1(d) enables FDA to
utility; (2) the accuracy of FDA’s Preemption—21 CFR 100.1(d) determine whether the State food
estimate of the burden of the proposed OMB Control Number 0910–0277— labeling or standard-of-identity
collection of information, including the Extension requirement satisfies the criteria of
validity of the methodology and section 403A(b) of the FD&C Act for
assumptions used; (3) ways to enhance Under section 403A(b) of the Federal granting exemption from Federal
the quality, utility, and clarity of the Food, Drug, and Cosmetic Act (the preemption.
information to be collected; and (4) FD&C Act) (21 U.S.C. 343–1(b)), States FDA estimates the burden of this
ways to minimize the burden of the may petition FDA for exemption from collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR 100.1(d) responses per burden per
respondents responses hours
respondent response
Form of petition .................................................................... 1 1 1 40 40
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is DATES: Fax written comments on the employed to achieve these goals include
minimal because petitions for collection of information by July 17, individual indepth interviews, general
exemption from preemption are seldom 2017. public focus group interviews, intercept
submitted by States. In the last 3 years, ADDRESSES: To ensure that comments on interviews, self-administered surveys,
we have received one new petition for the information collection are received, gatekeeper surveys, and focus group
exemption from preemption; therefore, OMB recommends that written interviews. The methods to be used
we estimate that one or fewer petitions comments be faxed to the Office of serve the narrowly defined need for
will be submitted annually. Information and Regulatory Affairs, direct and informal opinion on a
Dated: June 12, 2017. OMB, Attn: FDA Desk Officer, FAX: specific topic and as a qualitative and
202–395–7285, or emailed to oira_ quantitative research tool, and have two
Anna K. Abram,
submission@omb.eop.gov. All major purposes:
Deputy Commissioner for Policy, Planning, (1) To obtain information that is
Legislation, and Analysis. comments should be identified with the
OMB control number 0910—NEW and useful for developing variables and
[FR Doc. 2017–12445 Filed 6–14–17; 8:45 am]
‘‘Data to Support Social and Behavioral measures for formulating the basic
BILLING CODE 4164–01–P objectives of social and behavioral
Research as Used by the Food and Drug
Administration.’’ Also include the FDA research; and
docket number found in brackets in the (2) To assess the potential
DEPARTMENT OF HEALTH AND effectiveness of FDA communications,
HUMAN SERVICES heading of this document.
behavioral interventions, and other
FOR FURTHER INFORMATION CONTACT: materials in reaching and successfully
Food and Drug Administration Domini Bean, Office of Operations, communicating and addressing
Food and Drug Administration, Three behavioral change with their intended
[Docket No. FDA–2016–N–2683] White Flint North, 10A63, 11601 audiences.
Landsdown St., North Bethesda, MD FDA will use these methods to test
Agency Information Collection 20852, 301–796–5733, PRAStaff@ and refine its ideas and to help develop
Activities; Submission for Office of fda.hhs.gov. communication and behavioral
Management and Budget Review;
SUPPLEMENTARY INFORMATION: In strategies research, but will generally
Comment Request; Data To Support
compliance with 44 U.S.C. 3507, FDA conduct further research before making
Social and Behavioral Research as
has submitted the following proposed important decisions such as adopting
Used by the Food and Drug
collection of information to OMB for new policies and allocating or
Administration
review and clearance. redirecting significant resources to
AGENCY: Food and Drug Administration, support these policies.
Data To Support Social and Behavioral FDA’s Center for Drug Evaluation and
HHS. Research as Used by the Food and Drug Research, Center for Biologics
ACTION: Notice. Administration—OMB Control Number Evaluation and Research, Office of the
0910—NEW
pmangrum on DSK3GDR082PROD with NOTICES
Commissioner, and potentially other
SUMMARY: The Food and Drug Understanding patients, consumers, Agency components will use this
Administration (FDA) is announcing and health care professionals’ mechanism to test communications and
that a proposed collection of perceptions and behaviors plays an social and behavioral methods about
information has been submitted to the important role in improving FDA’s regulated drug products on a variety of
Office of Management and Budget regulatory decisionmaking processes subjects related to consumer, patient, or
(OMB) for review and clearance under and communications impacting various health care professional perceptions,
the Paperwork Reduction Act of 1995. stakeholders. The methods to be beliefs, attitudes, behaviors, and use of
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![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27493
drug and biological products and related document. FDA is requesting this comment on the proposed extension of
materials, including, but not limited to, burden so as not to restrict the Agency’s this collection of information. No
social and behavioral research, ability to gather information on public comments were received in response to
decisionmaking processes, and sentiment for its proposals in its the notice.
communication and behavioral change regulatory and communications
FDA estimates the burden of this
strategies. programs.
Annually, FDA estimates about 45 In the Federal Register of September collection of information as follows:
social and behavioral studies using the 19, 2016 (81 FR 64166), FDA published
variety of test methods listed in this a 60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Interviews/Surveys ..................................................... 2,520 14.6 36,792 0.25 (15 minutes) .... 9,198
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 12, 2017. ADDRESSES: You may submit comments Written/Paper Submissions
Anna K. Abram, as follows. Please note that late, Submit written/paper submissions as
Deputy Commissioner for Policy, Planning, untimely filed comments will not be follows:
Legislation, and Analysis. considered. Electronic comments must • Mail/Hand delivery/Courier (for
[FR Doc. 2017–12446 Filed 6–14–17; 8:45 am] be submitted on or before August 14, written/paper submissions): Division of
BILLING CODE 4164–01–P 2017. The https://www.regulations.gov Dockets Management (HFA–305), Food
electronic filing system will accept and Drug Administration, 5630 Fishers
comments until midnight Eastern Time Lane, Rm. 1061, Rockville, MD 20852.
DEPARTMENT OF HEALTH AND at the end of August 14, 2017. • For written/paper comments
HUMAN SERVICES Comments received by mail/hand submitted to the Division of Dockets
delivery/courier (for written/paper Management, FDA will post your
Food and Drug Administration comment, as well as any attachments,
submissions) will be considered timely
if they are postmarked or the delivery except for information submitted,
[Docket No. FDA–2014–D–0329] service acceptance receipt is on or marked and identified, as confidential,
before that date. if submitted as detailed in
Agency Information Collection ‘‘Instructions.’’
Activities; Proposed Collection; Electronic Submissions Instructions: All submissions received
Comment Request; Guidance for must include the Docket No. FDA–
Industry on Fees for Human Drug Submit electronic comments in the 2014–D–0329 for ‘‘Guidance for
Compounding Outsourcing Facilities following way: Industry on Fees for Human Drug
Under the Federal Food, Drug, and • Federal eRulemaking Portal: Compounding Outsourcing Facilities
Cosmetic Act https://www.regulations.gov. Follow the Under Sections 503B and 744K of the
instructions for submitting comments. Federal Food, Drug, and Cosmetic Act.’’
AGENCY: Food and Drug Administration,
Comments submitted electronically, Received comments, those filed in a
HHS.
including attachments, to https:// timely manner (see ADDRESSES), will be
ACTION: Notice. www.regulations.gov will be posted to placed in the docket and, except for
the docket unchanged. Because your those submitted as ‘‘Confidential
SUMMARY: The Food and Drug Submissions,’’ publicly viewable at
comment will be made public, you are
Administration (FDA or Agency) is https://www.regulations.gov or at the
solely responsible for ensuring that your
announcing an opportunity for public Division of Dockets Management
comment on the proposed collection of comment does not include any
confidential information that you or a between 9 a.m. and 4 p.m., Monday
certain information by the Agency. through Friday.
Under the Paperwork Reduction Act of third party may not wish to be posted,
such as medical information, your or • Confidential Submissions—To
1995 (PRA), Federal Agencies are submit a comment with confidential
required to publish notice in the anyone else’s Social Security number, or
confidential business information, such information that you do not wish to be
Federal Register concerning each made publicly available, submit your
proposed collection of information, as a manufacturing process. Please note
that if you include your name, contact comments only as a written/paper
including each proposed extension of an submission. You should submit two
existing collection of information, and information, or other information that
copies total. One copy will include the
to allow 60 days for public comment in identifies you in the body of your
information you claim to be confidential
response to the notice. This notice comments, that information will be
with a heading or cover note that states
solicits comments on the information posted on https://www.regulations.gov.
pmangrum on DSK3GDR082PROD with NOTICES
‘‘THIS DOCUMENT CONTAINS
collection in the guidance on Fees for • If you want to submit a comment CONFIDENTIAL INFORMATION.’’ The
Human Drug Compounding Outsourcing with confidential information that you Agency will review this copy, including
Facilities Under the Federal Food, Drug, do not wish to be made available to the the claimed confidential information, in
and Cosmetic Act (FD&C Act). public, submit the comment as a its consideration of comments. The
DATES: Submit either electronic or written/paper submission and in the second copy, which will have the
written comments on the collection of manner detailed (see ‘‘Written/Paper claimed confidential information
information by August 14, 2017. Submissions’’ and ‘‘Instructions’’). redacted/blacked out, will be available
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Document Created: 2017-06-15 01:03:48
Document Modified: 2017-06-15 01:03:48
| 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 July 17, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 27492 |
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