Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 31328-31330 [2021-12256]

Download as PDF 31328 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices address (§ 1210.22). Section 1210.20 requires that an application for a permit to ship or transport milk or cream into the United States be made by the actual shipper. Section 1210.23 allows permits to be granted based on certificates from accredited officials. Description of Respondents: Respondents include foreign dairy farms and plants engaged in transporting milk and/or cream into the United States. Respondents are from the private sector (for-profit businesses). In the Federal Register of November 4, 2020 (85 FR 70182), 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 21 CFR section 1210.11 1210.12 1210.13 1210.14 ........... ........... ........... ........... Number of responses per respondent Number of respondents Form FDA No. Total annual responses Average burden per response Total hours 1 1 1 1 200 1 1 1 200 1 1 1 1.5 ................................... 0.5 (30 minutes) ............. 0.5 (30 minutes) ............. 2 ...................................... 300 0.5 0.5 2 1 1 1 0.5 (30 minutes) ............. 0.5 1210.23 ........... 1996/Farm Inspection Report ................................. 1995/Report of Physical Examination of Cows ...... 1994/Report of Tuberculin Tests of Cattle ............. 1997/Score Card for Sanitation Inspections of Milk Plants. 1993/Application for Permit to Ship or Transport Milk and/or Cream into United States. 1815/Certificate/Transmittal for an Application ....... 1 1 1 0.5 (30 minutes) ............. 0.5 Total ........ ................................................................................. ........................ ........................ ........................ ......................................... 304 1210.20 ........... 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section; activity 1210.15 Pasteurization; Equipment and Methods ............................... jbell on DSKJLSW7X2PROD with NOTICES 1 There Number of records per recordkeeper 1 Total annual records 1 Average burden per recordkeeping 1 Total hours 0.05 (3 minutes) ............. 0.05 are no capital costs or operating and maintenance costs associated with this collection of information. The Secretary of Health and Human Services has the discretion to allow Form FDA 1815, a duly certified statement signed by an accredited official of a foreign government, to be submitted in lieu of Forms FDA 1994 and 1995. In the past, Form FDA 1815 has been submitted in lieu of these forms. Because we have not received any Forms FDA 1994 or 1995 in the last 3 years, we assume no more than 1 will be submitted annually. No burden has been estimated for the tagging requirement in § 1210.22 because the information on the tag is either supplied by us (permit number) or is disclosed to third parties as a usual and customary part of the shipper’s normal business activities (type of product, shipper’s name and address). Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not subject to review by OMB under the PRA. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of business activities. VerDate Sep<11>2014 19:14 Jun 10, 2021 Jkt 253001 Based on a review of the information collection since our last OMB approval, we have decreased our burden estimate. The estimated number of respondents and hours per response are based on our experience with the import milk permit program and the average number of import milk permit holders over the past 3 years. However, we have not received any responses in the last 3 years. Therefore, we estimate that one or fewer to be submitted annually. Although we have not received any responses in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need for a milk importer. Dated: June 3, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–12263 Filed 6–10–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0987] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) 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: Submit written comments (including recommendations) on the collection of information by July 12, 2021. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under SUMMARY: E:\FR\FM\11JNN1.SGM 11JNN1 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0796. Also include the FDA docket number found in brackets in the heading of this document. 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. FOR FURTHER INFORMATION CONTACT: 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: Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications OMB Control Number 0910–0796— Extension Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational and public information programs. In conducting studies relating to the regulation and communications related to tobacco products, FDA will need to employ formative qualitative research, including focus groups, usability testing, and/or indepth interviews (IDIs) to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve three major purposes. First, formative research will provide critical knowledge about target audiences. FDA must first understand people’s knowledge and perceptions about tobacco-related topics prior to developing survey/research questions as well as stimuli for experimental studies. Second, by collecting communications usability information, FDA will be able to serve and respond to the ever-changing demands of consumers of tobacco products. Additionally, we will be able to determine the best way to present messages. Third, initial testing will allow FDA to assess consumer understanding of survey/research questions and study stimuli. Focus groups and/or IDIs with a sample of the target audience will allow FDA to refine the survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, and interpret information gathered through this generic clearance in order to: (1) Better understand characteristics of the target audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/ research questions, study stimuli, or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies. FDA is requesting approval of an extension of this generic clearance for collecting information using qualitative methods (i.e., individual interviews, small group discussions, and focus groups) for studies involving all tobacco products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Focus groups play an important role in gathering information because they allow for an indepth understanding of individuals’ attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic. The number of respondents to be included in each new pretest may vary, depending on the nature of the material or message being tested and the target audience. Table 1 provides examples of the types of studies that may be administered and estimated burden 31329 levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the ‘‘Hours per Response’’ figures. Our estimated burden for the information collection reflects an overall increase of 5,641 hours and a corresponding increase of 16,585 responses. We attribute this adjustment to the number of study responses used during the current approval and now estimated for the next 3 years. In the Federal Register of September 29, 2020 (85 FR 60999), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two comments; however, only one was PRArelated. (Comment) The comment expressed support for FDA’s collection of qualitative research on tobacco products. The comment stated further that while FDA indicates that this research will meet the ‘‘narrowly defined need for direct and informal public opinion on a specific topic,’’ the Agency has recently used this work for broader purposes, including informing the Proposed Rule for graphic health warnings.’’ (Response) FDA appreciates the support for conducting qualitative research on tobacco products. FDA disagrees with the comment suggesting that the Agency has used its qualitative generic collection for ‘‘broader purposes’’ than contemplated by the generic collection. Review of a generic collection occurs in two stages: (1) A full PRA review of the generic clearance ICR, which includes the general approach and methodology, at least once every 3 years and (2) an expedited review of the individual collections that fall within the scope of the generic clearance. OMB reviewed the individual collection[s] that this comment cites and approved the collection, having determined that it was appropriately within the scope of the generic clearance. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents jbell on DSKJLSW7X2PROD with NOTICES Type of interview Number of responses per respondent Total annual responses Average burden per response Total hours In-Person Individual IDIs ...................................................................... IDI Screener ......................................................................................... Focus Group Screener ........................................................................ Focus Group Interviews ....................................................................... 1,092 1,800 19,385 5,897 1 1 1 1 1,092 1,800 19,385 5,897 1 ...................................... 0.083 (5 minutes) ........... 0.25 (15 minutes) ........... 1.5 ................................... 1,092 150 4,846 8,846 Total .............................................................................................. ........................ ........................ ........................ ......................................... 14,934 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 19:14 Jun 10, 2021 Jkt 253001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\11JNN1.SGM 11JNN1 31330 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices Dated: June 2, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–12256 Filed 6–10–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the COVID–19 Health Equity Task Force Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID–19 Health Equity Task Force (Task Force) will hold a virtual meeting on June 25, 2021. The purpose of this meeting is to consider interim recommendations addressing the inequities and the impact of longCOVID or Post-Acute Sequelae of SARS–CoV–2 infection (PASC), and access to personal protection equipment, testing, and therapeutics that are related to this pandemic. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/ healthequitytaskforce/ prior to the meeting. DATES: The Task Force meeting will be held on Friday, June 25, 2021, from 2 p.m. to approximately 6 p.m. ET (date and time are tentative and subject to change). The confirmed time and agenda will be posted on the COVID–19 Health Equity Task Force web page: www.minorityhealth.hhs.gov/ healthequitytaskforce/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: Samuel Wu, Designated Federal Officer for the Task Force; Office of Minority Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 100, Rockville, Maryland 20852. Phone: 240–453–6160; email: COVID19HETF@hhs.gov. SUPPLEMENTARY INFORMATION: Background: The COVID–19 Health Equity Task Force (Task Force) was established by Executive Order 13995, dated January 21, 2021. The Task Force is tasked with providing specific recommendations to the President, through the Coordinator of the COVID– jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:14 Jun 10, 2021 Jkt 253001 19 Response and Counselor to the President (COVID–19 Response Coordinator), for mitigating the health inequities caused or exacerbated by the COVID–19 pandemic and for preventing such inequities in the future. The Task Force shall submit a final report to the COVID–19 Response Coordinator addressing any ongoing health inequities faced by COVID–19 survivors that may merit a public health response, describing the factors that contributed to disparities in COVID–19 outcomes, and recommending actions to combat such disparities in future pandemic responses. The meeting is open to the public and will be live-streamed at www.hhs.gov/ live. No registration is required. A public comment session will be held during the meeting. Pre-registration is required to provide public comment during the meeting. To pre-register, please send an email to COVID19HETF@hhs.gov and include your name, title, and organization by close of business on Friday, June 18, 2021. Comments will be limited to no more than three minutes per speaker and should be pertinent to the meeting discussion. Individuals are encouraged to provide a written statement of any public comment(s) for accurate minutetaking purposes. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing COVID19HETF@hhs.gov no later than close of business on Thursday, July 1, 2021. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact: COVID19HETF@hhs.gov and reference this meeting. Requests for special accommodations should be made at least 10 business days prior to the meeting. Dated: June 8, 2021. Samuel Wu, Designated Federal Officer, COVID–19 Health Equity Task Force. [FR Doc. 2021–12320 Filed 6–10–21; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Nursing Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Nursing Research Initial Review Group. Date: June 24–25, 2021. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Nursing Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Cheryl Nordstrom, Ph.D., Scientific Review Officer, National Institute of Nursing Research, National Institutes of Health, 6701 Democracy Blvd., Suite 703H, Bethesda, MD 20892, (301) 827–1499, cheryl.nordstrom@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS) Dated: June 7, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–12234 Filed 6–10–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Multi-Omics Studies for Osteoporosis. Date: July 9, 2021. Time: 12:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31328-31330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12256]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
the Collection of Qualitative Data on Tobacco Products and 
Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) 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: Submit written comments (including recommendations) on the 
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under

[[Page 31329]]

Review--Open for Public Comments'' or by using the search function. The 
OMB control number for this information collection is 0910-0796. Also 
include the FDA docket number found in brackets in the heading of this 
document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Generic Clearance for the Collection of Qualitative Data on Tobacco 
Products and Communications

OMB Control Number 0910-0796--Extension

    Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational 
and public information programs.
    In conducting studies relating to the regulation and communications 
related to tobacco products, FDA will need to employ formative 
qualitative research, including focus groups, usability testing, and/or 
indepth interviews (IDIs) to assess knowledge and perceptions about 
tobacco-related topics with specific target audiences. The information 
collected will serve three major purposes. First, formative research 
will provide critical knowledge about target audiences. FDA must first 
understand people's knowledge and perceptions about tobacco-related 
topics prior to developing survey/research questions as well as stimuli 
for experimental studies. Second, by collecting communications 
usability information, FDA will be able to serve and respond to the 
ever-changing demands of consumers of tobacco products. Additionally, 
we will be able to determine the best way to present messages. Third, 
initial testing will allow FDA to assess consumer understanding of 
survey/research questions and study stimuli. Focus groups and/or IDIs 
with a sample of the target audience will allow FDA to refine the 
survey/research questions and study stimuli while they are still in the 
developmental stage. FDA will collect, and interpret information 
gathered through this generic clearance in order to: (1) Better 
understand characteristics of the target audience--its perceptions, 
knowledge, attitudes, beliefs, and behaviors--and use these in the 
development of appropriate survey/research questions, study stimuli, or 
communications; (2) more efficiently and effectively design survey/
research questions and study stimuli; and (3) more efficiently and 
effectively design experimental studies.
    FDA is requesting approval of an extension of this generic 
clearance for collecting information using qualitative methods (i.e., 
individual interviews, small group discussions, and focus groups) for 
studies involving all tobacco products regulated by FDA. This 
information will be used as a first step to explore concepts of 
interest and assist in the development of quantitative study proposals, 
complementing other important research efforts in the Agency. This 
information may also be used to help identify and develop communication 
messages, which may be used in education campaigns. Focus groups play 
an important role in gathering information because they allow for an 
indepth understanding of individuals' attitudes, beliefs, motivations, 
and feelings. Focus group research serves the narrowly defined need for 
direct and informal public opinion on a specific topic.
    The number of respondents to be included in each new pretest may 
vary, depending on the nature of the material or message being tested 
and the target audience. Table 1 provides examples of the types of 
studies that may be administered and estimated burden levels during the 
3-year period. Time to read, view, or listen to the message being 
tested is built into the ``Hours per Response'' figures. Our estimated 
burden for the information collection reflects an overall increase of 
5,641 hours and a corresponding increase of 16,585 responses. We 
attribute this adjustment to the number of study responses used during 
the current approval and now estimated for the next 3 years.
    In the Federal Register of September 29, 2020 (85 FR 60999), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments; however, only one 
was PRA-related.
    (Comment) The comment expressed support for FDA's collection of 
qualitative research on tobacco products. The comment stated further 
that while FDA indicates that this research will meet the ``narrowly 
defined need for direct and informal public opinion on a specific 
topic,'' the Agency has recently used this work for broader purposes, 
including informing the Proposed Rule for graphic health warnings.''
    (Response) FDA appreciates the support for conducting qualitative 
research on tobacco products. FDA disagrees with the comment suggesting 
that the Agency has used its qualitative generic collection for 
``broader purposes'' than contemplated by the generic collection. 
Review of a generic collection occurs in two stages: (1) A full PRA 
review of the generic clearance ICR, which includes the general 
approach and methodology, at least once every 3 years and (2) an 
expedited review of the individual collections that fall within the 
scope of the generic clearance. OMB reviewed the individual 
collection[s] that this comment cites and approved the collection, 
having determined that it was appropriately within the scope of the 
generic clearance.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              Type of interview                  Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-Person Individual IDIs...................           1,092               1           1,092  1.........................................           1,092
IDI Screener................................           1,800               1           1,800  0.083 (5 minutes).........................             150
Focus Group Screener........................          19,385               1          19,385  0.25 (15 minutes).........................           4,846
Focus Group Interviews......................           5,897               1           5,897  1.5.......................................           8,846
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          14,934
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 31330]]

    Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12256 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P