Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 62541-62543 [2019-24804]

Download as PDF 62541 Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices in brackets in the heading of this document. Q-Submission Program for Medical Devices FOR FURTHER INFORMATION CONTACT: OMB Control Number 0910–0756— Extension The guidance entitled ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’ (https://www.fda.gov/media/ 114034/download) provides an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with FDA regarding certain potential or planned medical device submissions reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The guidance provides recommendations regarding certain types of Q-Submissions, such as Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and other QSubmissions Types and other uses of the Q-Submission Program. For clarity and consistency with the guidance that describes the program, we are requesting that the title of the information collection request, OMB control number 0910–0756, be changed to ‘‘Q-Submission Program for Medical Devices.’’ In the Federal Register of August 13, 2019 (84 FR 40069), 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: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents FDA Center Annual frequency per response Total annual responses Hours per response Total hours CDRH ................................................................................... CBER ................................................................................... 3,502 91 1 1 3,502 91 137 137 479,774 12,467 Total .............................................................................. ........................ ........................ ........................ ........................ 492,241 1 There are no capital costs or operating and maintenance cost associated with this of information. Respondents are medical device manufacturers subject to FDA’s laws and regulations. FDA’s annual estimate of 3,593 submissions is based on experienced recent trends. FDA’s administrative and technical staffs, who are familiar with Q-Submissions, estimate that an average of 137 hours is required to prepare a Q-Submission. Our estimated burden for the information collection reflects an overall increase of 143,713 hours. We attribute this adjustment to an increase in the number of submissions we received based on FY18 data. Dated: November 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–24803 Filed 11–14–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:58 Nov 14, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0796] Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 the development and modification of communication messages and campaigns to fulfill the Agency’s mission to protect the public health. DATES: Submit either electronic or written comments on the collection of information by January 14, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 14, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 14, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are E:\FR\FM\15NON1.SGM 15NON1 62542 Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices 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 https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2013–N–0796 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 VerDate Sep<11>2014 16:58 Nov 14, 2019 Jkt 250001 for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3521), 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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. Testing Communications on Medical Devices and Radiation-Emitting Products OMB Control Number 0910–0678— Extension FDA is authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products. FDA must conduct needed research to ensure that such programs have the highest likelihood of being effective. Improving communications about medical devices and radiation emitting products will involve many research methods, including individual in-depth interviews, mall-intercept interviews, focus groups, selfadministered surveys, gatekeeper reviews, and omnibus telephone surveys. The information collected will serve three major purposes. First, as formative research it will provide critical knowledge needed about target audiences to develop messages and campaigns about medical device and radiation-emitting product use. Knowledge of consumer and health care professional decision-making processes will provide the better understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using medical devices and radiation-emitting products by providing users with a better context in which to place risk information more completely. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Testing messages with a sample of the target audience will allow FDA to refine messages while still in the developmental stage. Respondents will be asked to give their reaction to the E:\FR\FM\15NON1.SGM 15NON1 Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices messages in either individual or group settings. Third, as evaluative research, it will allow FDA to ascertain the effectiveness of the messages and the distribution method of these messages in achieving the objectives of the message campaign. Evaluation of campaigns is a vital link in continuous improvement of communications at FDA. Annually, FDA projects conducting about 30 studies using a variety of research methods and lasting an average of 0.17 hours each (varying from 0.08 to 1.5 hours). FDA estimates the burden of this collection of information based on prior experience with the various types 62543 of data collection methods described earlier. 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 respondents Activity Number of responses per respondent Average burden per response Total annual responses Total hours Individual In-Depth Interviews ..................................... General Public Focus Group Interviews ..................... Intercept Interviews: Central Location ......................... Intercept Interviews: Telephone .................................. Self-Administered Surveys .......................................... Gatekeeper Reviews ................................................... Omnibus Surveys ........................................................ 360 144 200 4,000 2,400 400 1,200 1 1 1 1 1 1 1 360 144 200 4,000 2,400 400 1,200 0.75 (45 minutes) ... 1.5 .......................... 0.25 (15 minutes) .. 0.08 (5 minutes) ..... 0.25 (15 minutes) ... 0.5 (30 minutes) ..... 0.17 (10 minutes) ... 270 216 50 320 600 200 204 Total (General Public) .......................................... Physician Focus Group Interviews .............................. 8,704 144 ........................ 1 8,702 144 ................................ 1.5 .......................... 1,860 216 Total (Physician) ................................................... 144 ........................ ........................ ................................ 216 Total (Overall) ............................................... 8,848 ........................ ........................ ................................ 2,076 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Dated: November 7, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. Name of Committee: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. Date: January 12–14, 2020. Time: 6:00 p.m. to 12:00 p.m. Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Lorna W. Role, Ph.D., Scientific Director, Division of Intramural Research, National Institute of Neurological Disorders and Stroke, 35A Convent Drive, MSC 3716, Bethesda, MD 20892, lorna.role@ nih.gov. Name of Committee: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. Date: March 22–24, 2020. Time: 6:00 p.m. to 12:00 p.m. Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Lorna W. Role, Ph.D., Scientific Director, Division of Intramural Research, National Institute of Neurological Disorders and Stroke, 35A Convent Drive, MSC 3716, Bethesda, MD 20892, lorna.role@ nih.gov. Name of Committee: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. Date: June 21–23, 2020. Time: 6:00 p.m. to 12:00 p.m. [FR Doc. 2019–24804 Filed 11–14–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. The meetings will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE, including consideration of personnel qualifications and performance, and the competence of VerDate Sep<11>2014 16:58 Nov 14, 2019 Jkt 250001 PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Lorna W. Role, Ph.D., Scientific Director, Division of Intramural Research, National Institute of Neurological Disorders and Stroke, 35A Convent Drive, MSC 3716, Bethesda, MD 20892, lorna.role@ nih.gov. Name of Committee: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. Date: October 4–6, 2020. Time: 6:00 p.m. to 12:00 p.m. Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Lorna W. Role, Ph.D., Scientific Director, Division of Intramural Research, National Institute of Neurological Disorders and Stroke, 35A Convent Drive, MSC 3716, Bethesda, MD 20892, lorna.role@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: November 7, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–24775 Filed 11–14–19; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62541-62543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24804]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0796]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Testing Communications on Medical Devices and 
Radiation-Emitting Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on communication studies involving medical 
devices and radiation-emitting products regulated by FDA. This 
information will be used to explore concepts of interest and assist in 
the development and modification of communication messages and 
campaigns to fulfill the Agency's mission to protect the public health.

DATES: Submit either electronic or written comments on the collection 
of information by January 14, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 14, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 14, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are

[[Page 62542]]

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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2013-N-0796 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Testing Communications on Medical 
Devices and Radiation-Emitting Products.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Testing Communications on Medical Devices and Radiation-Emitting 
Products

OMB Control Number 0910-0678--Extension

    FDA is authorized by section 1003(d)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational 
and public information programs relating to the safety of regulated 
medical devices and radiation-emitting products. FDA must conduct 
needed research to ensure that such programs have the highest 
likelihood of being effective. Improving communications about medical 
devices and radiation emitting products will involve many research 
methods, including individual in-depth interviews, mall-intercept 
interviews, focus groups, self-administered surveys, gatekeeper 
reviews, and omnibus telephone surveys.
    The information collected will serve three major purposes. First, 
as formative research it will provide critical knowledge needed about 
target audiences to develop messages and campaigns about medical device 
and radiation-emitting product use. Knowledge of consumer and health 
care professional decision-making processes will provide the better 
understanding of target audiences that FDA needs to design effective 
communication strategies, messages, and labels. These communications 
will aim to improve public understanding of the risks and benefits of 
using medical devices and radiation-emitting products by providing 
users with a better context in which to place risk information more 
completely.
    Second, as initial testing, it will allow FDA to assess the 
potential effectiveness of messages and materials in reaching and 
successfully communicating with their intended audiences. Testing 
messages with a sample of the target audience will allow FDA to refine 
messages while still in the developmental stage. Respondents will be 
asked to give their reaction to the

[[Page 62543]]

messages in either individual or group settings.
    Third, as evaluative research, it will allow FDA to ascertain the 
effectiveness of the messages and the distribution method of these 
messages in achieving the objectives of the message campaign. 
Evaluation of campaigns is a vital link in continuous improvement of 
communications at FDA.
    Annually, FDA projects conducting about 30 studies using a variety 
of research methods and lasting an average of 0.17 hours each (varying 
from 0.08 to 1.5 hours). FDA estimates the burden of this collection of 
information based on prior experience with the various types of data 
collection methods described earlier. 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
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual In-Depth Interviews...............             360               1             360  0.75 (45 minutes)........................             270
General Public Focus Group Interviews........             144               1             144  1.5......................................             216
Intercept Interviews: Central Location.......             200               1             200  0.25 (15 minutes)........................              50
Intercept Interviews: Telephone..............           4,000               1           4,000  0.08 (5 minutes).........................             320
Self-Administered Surveys....................           2,400               1           2,400  0.25 (15 minutes)........................             600
Gatekeeper Reviews...........................             400               1             400  0.5 (30 minutes).........................             200
Omnibus Surveys..............................           1,200               1           1,200  0.17 (10 minutes)........................             204
                                              ----------------------------------------------------------------------------------------------------------
    Total (General Public)...................           8,704  ..............           8,702  .........................................           1,860
Physician Focus Group Interviews.............             144               1             144  1.5......................................             216
                                              ----------------------------------------------------------------------------------------------------------
    Total (Physician)........................             144  ..............  ..............  .........................................             216
                                              ----------------------------------------------------------------------------------------------------------
        Total (Overall)......................           8,848  ..............  ..............  .........................................           2,076
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24804 Filed 11-14-19; 8:45 am]
BILLING CODE 4164-01-P


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