81_FR_64347 81 FR 64166 - Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration

81 FR 64166 - Agency Information Collection Activities; Proposed Collection; 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 81, Issue 181 (September 19, 2016)

Page Range64166-64167
FR Document2016-22437

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information to support social and behavioral research used by FDA about drug products.

Federal Register, Volume 81 Issue 181 (Monday, September 19, 2016) 
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64166-64167]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2683]


Agency Information Collection Activities; Proposed Collection; 
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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a generic clearance to collect information 
to support social and behavioral research used by FDA about drug 
products.

DATES: Submit either electronic or written comments on the collection 
of information by November 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2683 for ``Data To Support Social and Behavioral Research as 
Used by the Food and Drug Administration.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

[[Page 64167]]

    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 any other 
Centers or Offices 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 healthcare 
professional perceptions, beliefs, attitudes, behaviors and use of 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 projects 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys.................................................          20,000                1           20,000               15            5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22437 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P

64166 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices the technical requirements for the DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper approval of pharmaceuticals for human HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). use in the ICH regions over the past two Written/Paper Submissions decades. The current ICH process and Food and Drug Administration structure can be found at the following Submit written/paper submissions as [Docket No. FDA–2016–N–2683] follows: Web site: http://www.ich.org. (FDA has • Mail/Hand delivery/Courier (for verified the Web site addresses as of the Agency Information Collection written/paper submissions): Division of date this document publishes in the Activities; Proposed Collection; Dockets Management (HFA–305), Food Federal Register, but Web sites are Comment Request; Data To Support and Drug Administration, 5630 Fishers subject to change over time.) Social and Behavioral Research as Lane, rm. 1061, Rockville, MD 20852. II. Webinar Attendance and Used by the Food and Drug • For written/paper comments Administration submitted to the Division of Dockets Participation AGENCY: Food and Drug Administration, Management, FDA will post your A. Registration HHS. comment, as well as any attachments, except for information submitted, If you wish to attend the meeting, ACTION: Notice. marked and identified, as confidential, please register at the following Web site: if submitted as detailed in SUMMARY: The Food and Drug https://healthcanada-usfda_ich_ ‘‘Instructions.’’ Administration (FDA) is announcing an consultation.eventbrite.ca. Registrations Instructions: All submissions received opportunity for public comment on the may be limited, so early registration is must include the Docket No. FDA– proposed collection of certain recommended. Registration is free and 2016–N–2683 for ‘‘Data To Support information by the Agency. Under the will be on a first-come, first-served Social and Behavioral Research as Used Paperwork Reduction Act of 1995 (the basis. However, the number of by the Food and Drug Administration.’’ PRA), Federal Agencies are required to participants from each organization may Received comments will be placed in publish notice in the Federal Register be limited based on space limitations. the docket and, except for those concerning each proposed collection of Registrants will receive confirmation submitted as ‘‘Confidential information and to allow 60 days for Submissions,’’ publicly viewable at once they have been accepted. If you public comment in response to the need special accommodations because http://www.regulations.gov or at the notice. This notice solicits comments on Division of Dockets Management of a disability, please contact Amanda a generic clearance to collect between 9 a.m. and 4 p.m., Monday Roache (see FOR FURTHER INFORMATION information to support social and through Friday. CONTACT) at least 7 days before the behavioral research used by FDA about • Confidential Submissions—To Webinar. drug products. submit a comment with confidential DATES: Submit either electronic or information that you do not wish to be B. Requests for Oral Presentations written comments on the collection of made publicly available, submit your Interested persons may present data, information by November 18, 2016. comments only as a written/paper information, or views orally or in ADDRESSES: You may submit comments submission. You should submit two writing on issues pending at the public as follows: copies total. One copy will include the Webinar. Public oral presentations will information you claim to be confidential Electronic Submissions with a heading or cover note that states be scheduled between approximately 2:30 p.m. and 3 p.m. Time allotted for Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS oral presentations may be limited to 5 following way: CONFIDENTIAL INFORMATION.’’ The minutes. Those desiring to make oral • Federal eRulemaking Portal: http:// Agency will review this copy, including presentations should notify Amanda www.regulations.gov. Follow the the claimed confidential information, in Roache (see FOR FURTHER INFORMATION instructions for submitting comments. its consideration of comments. The CONTACT) by October 19, 2016, and Comments submitted electronically, second copy, which will have the including attachments, to http:// claimed confidential information submit a brief statement of the general www.regulations.gov will be posted to redacted/blacked out, will be available nature of the evidence or arguments the docket unchanged. Because your for public viewing and posted on http:// they wish to present; the names and comment will be made public, you are www.regulations.gov. Submit both addresses, telephone number, FAX, and solely responsible for ensuring that your copies to the Division of Dockets email of proposed participants; and an comment does not include any Management. If you do not wish your indication of the approximate time confidential information that you or a name and contact information to be requested to make their presentation. third party may not wish to be posted, made publicly available, you can The agenda for the public Webinar will such as medical information, your or provide this information on the cover be made available on the Internet at anyone else’s Social Security number, or sheet and not in the body of your http://www.fda.gov/Drugs/NewsEvents/ confidential business information, such comments and you must identify this ucm516166.htm. as a manufacturing process. Please note information as ‘‘confidential.’’ Any Dated: September 14, 2016. that if you include your name, contact information marked as ‘‘confidential’’ Leslie Kux, information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other mstockstill on DSK3G9T082PROD with NOTICES Associate Commissioner for Policy. comments, that information will be applicable disclosure law. For more [FR Doc. 2016–22471 Filed 9–16–16; 8:45 am] posted on http://www.regulations.gov. information about FDA’s posting of BILLING CODE 4164–01–P • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ public, submit the comment as a regulatoryinformation/dockets/ written/paper submission and in the default.htm. VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1

Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices 64167 Docket: For access to the docket to the proposed collection of information 2. To assess the potential effectiveness of read background documents or the is necessary for the proper performance FDA communications, behavioral electronic and written/paper comments of FDA’s functions, including whether interventions and other materials in reaching received, go to http:// the information will have practical and successfully communicating and addressing behavioral change with their www.regulations.gov and insert the utility; (2) the accuracy of FDA’s intended audiences. docket number, found in brackets in the estimate of the burden of the proposed heading of this document, into the collection of information, including the FDA will use these methods to test ‘‘Search’’ box and follow the prompts validity of the methodology and and refine its ideas and to help develop and/or go to the Division of Dockets assumptions used; (3) ways to enhance communication and behavioral Management, 5630 Fishers Lane, Rm. the quality, utility, and clarity of the strategies research, but will generally 1061, Rockville, MD 20852. information to be collected; and (4) conduct further research before making FOR FURTHER INFORMATION CONTACT: FDA ways to minimize the burden of the important decisions such as adopting PRA Staff, Office of Operations, Food collection of information on new policies and allocating or and Drug Administration, Three White respondents, including through the use redirecting significant resources to Flint North 10A63, 11601 Landsdown of automated collection techniques, support these policies. St., North Bethesda, MD 20852, when appropriate, and other forms of FDA’s Center for Drug Evaluation and PRAStaff@fda.hhs.gov. information technology. Research, Center for Biologics SUPPLEMENTARY INFORMATION: Under the Evaluation and Research, Office of the Data To Support Social and Behavioral PRA (44 U.S.C. 3501–3520), Federal Research as Used by the Food and Drug Commissioner, and any other Centers or Agencies must obtain approval from the Administration—(OMB Control Offices will use this mechanism to test Office of Management and Budget Number 0910—NEW) communications and social and (OMB) for each collection of behavioral methods about regulated information they conduct or sponsor. Understanding patients, consumers drug products on a variety of subjects ‘‘Collection of information’’ is defined and health care professionals’ related to consumer, patient, or in 44 U.S.C. 3502(3) and 5 CFR perceptions and behaviors plays an healthcare professional perceptions, 1320.3(c) and includes Agency requests important role in improving FDA’s beliefs, attitudes, behaviors and use of or requirements that members of the regulatory decisionmaking processes drug and biological products and related public submit reports, keep records, or and communications impacting various materials, including, but not limited to, provide information to a third party. stakeholders. The methods to be social and behavioral research, Section 3506(c)(2)(A) of the PRA (44 employed to achieve these goals include decisionmaking processes, and U.S.C. 3506(c)(2)(A)) requires Federal individual indepth interviews, general communication and behavioral change Agencies to provide a 60-day notice in public focus group interviews, intercept strategies. the Federal Register concerning each interviews, self-administered surveys, proposed collection of information, gatekeeper surveys, and focus group Annually, FDA projects about 45 including each proposed extension of an interviews. The methods to be used social and behavioral studies using the existing collection of information, serve the narrowly defined need for variety of test methods listed in this before submitting the collection to OMB direct and informal opinion on a document. FDA is requesting this for approval. To comply with this specific topic and as a qualitative and burden so as not to restrict the Agency’s requirement, FDA is publishing notice quantitative research tool, and have two ability to gather information on public of the proposed collection of major purposes: sentiment for its proposals in its information set forth in this document. regulatory and communications 1. To obtain information that is useful for With respect to the following programs. developing variables and measures for collection of information, FDA invites formulating the basic objectives of social and FDA estimates the burden of this comments on these topics: (1) Whether behavioral research and; collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of responses Total annual burden per Activity Total hours respondents per responses response respondent (minutes) Interviews/Surveys ............................................................... 20,000 1 20,000 15 5,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–22437 Filed 9–16–16; 8:45 am] BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 E:\FR\FM\19SEN1.SGM 19SEN1


Document Created: 2016-09-17 02:30:45
Document Modified: 2016-09-17 02:30:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by November 18, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 64166 
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