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, 72685-72686 [2014-28635]

Download as PDF Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10535] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. 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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by February 6, 2015: ADDRESSES: When commenting, please reference the document identifier or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ll Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:19 Dec 05, 2014 Jkt 235001 To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of the following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10535 Employer Notification to HHS of Its Objection to Providing Coverage for Contraceptive Services 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. The term ‘‘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 requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Employer Notification to HHS of its Objection to Providing Coverage for Contraceptive Services; Use: The proposed rules titled ‘‘Coverage of Certain Preventive Services Under the Affordable Care Act’’ (79 FR 51118) would continue to require each closely-held, for-profit corporation seeking to be treated as an eligible organization to provide notification that PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 72685 it will not act as the plan administrator or claims administrator with respect to, or contribute to the funding of, coverage of all or a subset of contraceptive services. Issuers and third party administrators providing payments for contraceptive services for participants and beneficiaries in plans of eligible organizations would be required to meet the notice requirements as set forth in the 2013 final regulations. The interim final regulations titled ‘‘Coverage of Certain Preventive Services Under the Affordable Care Act’’ (79 FR 51092) continue to allow eligible organizations that have religious objections to providing contraceptive coverage to notify an issuer or third party administrator using EBSA Form 700, as set forth in the July 2013 final regulations. In addition, the interim final regulations permit an alternative process under which an eligible organization could notify the Secretary of HHS that it will not act as the plan administrator or claims administrator with respect to, or contribute to the funding of, coverage of all or a subset of contraceptive services. Form Number: CMS–10535 (OMB control number: 0938–1248); Frequency: Once; Affected Public: Private Sector—For-profit and Not-for-profit institutions; Number of Respondents: 61; Number of Responses: 61; Total Annual Hours: 51. (For policy questions regarding this collection, contact Usree Bandyopadhyay at 410– 786–6650.) Dated: December 2, 2014. Martique Jones Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–28632 Filed 12–5–14; 8:45 am] BILLING CODE 4120–01–P 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) is announcing that a proposed collection of information has been submitted to the SUMMARY: E:\FR\FM\08DEN1.SGM 08DEN1 72686 Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 7, 2015. 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 title ‘‘Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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. Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications—(OMB Control Number 0910—New) Under 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 and/or in-depth interviews (IDIs) to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve two 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, 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, analyze, 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 this new generic clearance for collecting information through the use of 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 in-depth 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. In the Federal Register of August 1, 2014 (79 FR 44779), FDA published a 60-day notice requesting public comment on the proposed collection of information. Two comments were received. However, only one comment was PRA-related. (Comment) One comment was supportive of the information collection, stating that such ‘‘collections are, in fact, essential.’’ The comment also made suggestions about what the specific goals of messages tested in information collections included under this generic collection should focus on, and suggested that those collections be made available for further public comments. (Response) FDA agrees that the request in this collection of information is essential to the mission of the FDA as a science-based Agency in its implementation of the Tobacco Control Act. Although we appreciate suggestions for the content of future submissions submitted under this generic clearance, ultimately such decisions will be driven by needs determined by the Agency in consultation with other HHS agencies, FDA advisory committees, and/or the public when appropriate. 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 Total annual responses In Person Individual In-Depth Interviews ............................... General Public Focus Group Interviews ................................ Telephone Screening Interviews ............................................ 350 18,850 4,800 1 1 1 350 18,850 4,800 Telephone Individual In-Depth Interviews .............................. 50 1 Total ................................................................................ 24,050 ........................ mstockstill on DSK4VPTVN1PROD with NOTICES 1 There Hours per response Total hours 350 28,275 384 50 1 .................. 1.5 ............... .08 ............... (5 minutes) .. 1 .................. ........................ ..................... 29,059 50 are no capital costs or operating and maintenance costs associated with this collection of information. 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 VerDate Sep<11>2014 20:19 Dec 05, 2014 Jkt 235001 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. PO 00000 Frm 00066 Fmt 4703 Sfmt 9990 Dated: December 1, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28635 Filed 12–5–14; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72685-72686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28635]

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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) is announcing that a
proposed collection of information has been submitted to the

[[Page 72686]]

Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
7, 2015.

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
title ``Generic Clearance for the Collection of Qualitative Data on
Tobacco Products and Communications.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.

Generic Clearance for the Collection of Qualitative Data on Tobacco
Products and Communications--(OMB Control Number 0910--New)

Under 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 and/or in-depth interviews
(IDIs) to assess knowledge and perceptions about tobacco-related topics
with specific target audiences. The information collected will serve
two 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, 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,
analyze, 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 this new generic clearance for
collecting information through the use of 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
in-depth 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.
In the Federal Register of August 1, 2014 (79 FR 44779), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received. However, only
one comment was PRA-related.
(Comment) One comment was supportive of the information collection,
stating that such ``collections are, in fact, essential.'' The comment
also made suggestions about what the specific goals of messages tested
in information collections included under this generic collection
should focus on, and suggested that those collections be made available
for further public comments.
(Response) FDA agrees that the request in this collection of
information is essential to the mission of the FDA as a science-based
Agency in its implementation of the Tobacco Control Act. Although we
appreciate suggestions for the content of future submissions submitted
under this generic clearance, ultimately such decisions will be driven
by needs determined by the Agency in consultation with other HHS
agencies, FDA advisory committees, and/or the public when appropriate.
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 Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
In Person Individual In-Depth 350 1 350 1................ 350
Interviews.
General Public Focus Group 18,850 1 18,850 1.5.............. 28,275
Interviews.
Telephone Screening 4,800 1 4,800 .08.............. 384
Interviews. (5 minutes)......
Telephone Individual In-Depth 50 1 50 1................ 50
Interviews.
----------------------------------------------------------------------------------
Total.................... 24,050 .............. .............. ................. 29,059
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

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.

Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28635 Filed 12-5-14; 8:45 am]
BILLING CODE 4164-01-P

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