Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration, 5219-5220 [2021-01030]

Download as PDF Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices [FR Doc. 2021–01022 Filed 1–15–21; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0345] khammond on DSKJM1Z7X2PROD with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration AGENCY: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget SUMMARY: VerDate Sep<11>2014 19:19 Jan 17, 2021 Jkt 253001 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: Food and Drug Administration, HHS. ACTION: (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by February 18, 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 Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0695. Also include the FDA docket number found in brackets in the heading of this document. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 collection of information to OMB for review and clearance. Data to Support Drug Product Communications as Used by the Food and Drug Administration OMB Control Number 0910–0695— Extension This information collection supports Agency outreach efforts. Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an indepth understanding of individuals’ attitudes, beliefs, motivations, and feelings. The methods to be employed include individual indepth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews, all on a voluntary basis. The methods to be used serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative research tool, have two major purposes: (1) To obtain information that is useful for developing variables and measures for formulating the basic objectives of risk E:\FR\FM\19JAN1.SGM 19JAN1 EN19JA21.024</GPH> Dated: January 12, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. 5219 5220 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices communication campaigns and (2) to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. We will use these methods to test and refine our ideas and to help develop messages and other communications 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. We will use this mechanism to test messages about regulated drug products on a variety of subjects related to consumer, patient, or healthcare professional perceptions and about use of drug products and related materials, including but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, medication guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sale of medical products, and consumer and professional education. Annually, we project about 45 communication studies using the variety of test methods listed in this document. We are requesting an extension of these burden hours so as not to restrict our ability to gather information on public sentiment for FDA’s proposals in its regulatory and communications programs. In the Federal Register of June 17, 2020 (85 FR 36591), we published a 60day 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 Interviews/Surveys ............................ 1 There 43,875 Total annual responses 1 43,875 Average burden per response 0.21925 (12 minutes) ....................... Total hours 9,620 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: January 11, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–01030 Filed 1–15–21; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR Part 60 Regulations and Forms, OMB No. 0915–0126—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from SUMMARY: VerDate Sep<11>2014 19:19 Jan 17, 2021 Jkt 253001 the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30 day comment period for this notice has closed. Comments on this ICR should be received no later than February 18, 2021. DATES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR Part 60 Regulations and Forms, OMB No. 0915–0126—Revision. Abstract: This is a request for OMB’s approval for a revision to the information collection contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. ADDRESSES: BILLING CODE 4164–01–P khammond on DSKJM1Z7X2PROD with NOTICES Number of responses per respondent Number of respondents Activity PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 Administrative forms are also included to aid in monitoring compliance with federal reporting and querying requirements. Responsibility for NPDB implementation and operation resides in HRSA’s Bureau of Health Workforce. The intent of the NPDB is to improve the quality of health care by encouraging entities such as hospitals, State licensing boards, professional societies, and other eligible entities 1 providing health care services to identify and discipline those who engage in unprofessional behavior, and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from state to state without disclosure or discovery of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, federal agencies, and state agencies. Users of the NPDB include reporters (entities that are required to 1 ‘‘Other eligible entities’’ that participate in the NPDB are defined in the provisions of Title IV, Section 1921, Section 1128E, and implementing regulations. In addition, a few federal agencies also participate with the NPDB through federal memorandums of understanding. Eligible entities are responsible for complying with all reporting and/or querying requirements that apply; some entities may qualify as more than one type of eligible entity. Each eligible entity must certify its eligibility in order to report to the NPDB, query the NPDB, or both. Information from the NPDB is available only to those entities specified as eligible in the statutes and regulations. Not all entities have the same reporting requirements or level of query access. E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5219-5220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01030]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0345]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Data To Support Drug 
Product Communications as Used by the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 February 18, 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 Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0695. 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.

Data to Support Drug Product Communications as Used by the Food and 
Drug Administration

OMB Control Number 0910-0695--Extension

    This information collection supports Agency outreach efforts. 
Testing of communication messages in advance of a communication 
campaign provides an important role in improving FDA communications as 
they allow for an indepth understanding of individuals' attitudes, 
beliefs, motivations, and feelings. The methods to be employed include 
individual indepth interviews, general public focus group interviews, 
intercept interviews, self-administered surveys, gatekeeper surveys, 
and professional clinician focus group interviews, all on a voluntary 
basis.
    The methods to be used serve the narrowly defined need for direct 
and informal opinion on a specific topic and, as a qualitative research 
tool, have two major purposes: (1) To obtain information that is useful 
for developing variables and measures for formulating the basic 
objectives of risk

[[Page 5220]]

communication campaigns and (2) to assess the potential effectiveness 
of messages and materials in reaching and successfully communicating 
with their intended audiences. We will use these methods to test and 
refine our ideas and to help develop messages and other communications 
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. We will use this 
mechanism to test messages about regulated drug products on a variety 
of subjects related to consumer, patient, or healthcare professional 
perceptions and about use of drug products and related materials, 
including but not limited to, direct-to-consumer prescription drug 
promotion, physician labeling of prescription drugs, medication guides, 
over-the-counter drug labeling, emerging risk communications, patient 
labeling, online sale of medical products, and consumer and 
professional education.
    Annually, we project about 45 communication studies using the 
variety of test methods listed in this document. We are requesting an 
extension of these burden hours so as not to restrict our ability to 
gather information on public sentiment for FDA's proposals in its 
regulatory and communications programs.
    In the Federal Register of June 17, 2020 (85 FR 36591), we 
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
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Interviews/Surveys............          43,875               1          43,875  0.21925 (12                9,620
                                                                                 minutes).
----------------------------------------------------------------------------------------------------------------
\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: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-01030 Filed 1-15-21; 8:45 am]
BILLING CODE 4164-01-P

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