Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration, 72369-72370 [2019-28247]

Download as PDF 72369 Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices Section 830.360 requires each labeler to retain records showing all UDIs used to identify devices that must be labeled with a UDI and the particular version or model associated with each device identifier, until 3 years after it ceases to market a version or model of a device. Respondents who are required to submit data to the Agency under certain other approved information collections (listed below) are required to include UDI data elements for the device that is the subject of such information collection. Addition of the UDI data elements is included in this burden estimate for the conforming amendments in the following 21 CFR parts: Part 803—Medical Device Reporting (OMB control number 0910–0437), Part 806—Medical Devices; Reports of Corrections and Removals (OMB control number 0910–0359), Part 814—Premarket Approval of Medical Devices (OMB control number 0910–0231), Part 820—Quality System Regulation (OMB control number 0910–0073), Part 821—Medical Device Tracking Requirements (OMB control number 0910–0442), and Part 822—Postmarket Surveillance (OMB control number 0910–0449). In the Federal Register of July 31, 2019 (84 FR 37315), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL BURDEN Number of respondents 1 Reporting .......................................................................... Recordkeeping ................................................................. Third-Party Disclosure ...................................................... Number of responses per respondent 2 6,199 5,987 5,987 51 51 51 Total annual responses 3 316,149 305,337 305,337 Average burden per response 4 0.023 (1 minute) ......... 0.989 (59 minutes) ..... 0.885 (53 minutes) ..... Total hours 5 7,289 302,121 270,143 Total capital costs and operating and maintenance costs $425,000 14,733,333 13,033,333 1 Maximum number of respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer respondents. 2 Maximum number of responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer responses. 3 Maximum total annual responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer total annual responses. 4 Rounded to three decimals. Total hours reflects a more precise, non-rounded average burden per response. An approximate (non-rounded) conversion to minutes is shown in parentheses. 5 Total hours is based on a more precise burden per response than the rounded value show in this table. 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: December 13, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–28246 Filed 12–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–3586] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, khammond on DSKJM1Z7X2PROD with NOTICES 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 (PRA). SUMMARY: 18:32 Dec 30, 2019 Focus Groups About Drug Products as Used by the Food and Drug Administration 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 0910–0677. Also include the FDA docket number found in brackets in the heading of this document. OMB Control Number 0910–0677— Extension Focus groups provide an important role in gathering information because they allow for a more indepth understanding of individuals’ attitudes, beliefs, motivations, and feelings than do quantitative studies. Focus groups serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative research tool, have three major purposes: • To obtain information that is useful for developing variables and measures for quantitative studies; • to better understand people’s attitudes and emotions in response to topics and concepts; and • to further explore findings obtained from quantitative studies. We use information gathered from focus group findings to test and refine 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. Our Center for Drug Evaluation and Research, as well as other Agency components, engage focus groups about ADDRESSES: 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. 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: Notice. VerDate Sep<11>2014 Fax written comments on the collection of information by January 30, 2020. FOR FURTHER INFORMATION CONTACT: HHS. ACTION: DATES: Jkt 250001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\31DEN1.SGM 31DEN1 72370 Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices regulated drug products on a variety of topics related to consumer, patient, or healthcare professional perceptions and use of drug products and related materials. These materials may include, but are not limited to direct-toconsumer prescription drug promotion, physician labeling of prescription drugs, medication guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sales of medical products, and consumer and professional education. In the Federal Register of July 17, 2019 (84 FR 34186), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. Annually, we project that 20 studies will be initiated using 160 focus groups with an average of 9 persons per group. We assume each focus group will last an average of 1.75 hours. We estimate the burden for the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Focus Group Study .............................................................. 1,440 1 1,440 1.75 2,520 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: December 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–28247 Filed 12–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–5955] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; AB-FUBINACA; 5FAMB-PINACA; 5F-MDMB-PICA; 4-FMDMB-BINACA; 4-CMC; Nethylhexedrone; alpha-PHP; DOC; Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam and Etizolam; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States’ position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:30 Dec 30, 2019 Jkt 250001 Vienna, Austria, in March 2020. This notice is issued under the Controlled Substances Act (CSA). DATES: Submit either electronic or written comments by January 30, 2020. The short time period for the submission of comments is needed to ensure that Health and Human Services (HHS) may, in a timely fashion, carry out the required action and be responsive to the United Nations. 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 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 30, 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 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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 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-2019N-5955 for ‘‘International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; AB-FUBINACA; 5FAMB-PINACA; 5F-MDMB-PICA; 4-FMDMB-BINACA; 4-CMC; Nethylhexedrone; alpha-PHP; DOC; Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam and Etizolam; Request for Comments.’’ 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 E:\FR\FM\31DEN1.SGM 31DEN1

Agencies

[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72369-72370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28247]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3586]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Focus Groups About 
Drug Products as Used by the Food and Drug Administration

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 (PRA).

DATES: Fax written comments on the collection of information by January 
30, 2020.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0677. 
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.

Focus Groups About Drug Products as Used by the Food and Drug 
Administration

OMB Control Number 0910-0677--Extension

    Focus groups provide an important role in gathering information 
because they allow for a more indepth understanding of individuals' 
attitudes, beliefs, motivations, and feelings than do quantitative 
studies. Focus groups serve the narrowly defined need for direct and 
informal opinion on a specific topic and, as a qualitative research 
tool, have three major purposes:
     To obtain information that is useful for developing 
variables and measures for quantitative studies;
     to better understand people's attitudes and emotions in 
response to topics and concepts; and
     to further explore findings obtained from quantitative 
studies.
    We use information gathered from focus group findings to test and 
refine 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.
    Our Center for Drug Evaluation and Research, as well as other 
Agency components, engage focus groups about

[[Page 72370]]

regulated drug products on a variety of topics related to consumer, 
patient, or healthcare professional perceptions and use of drug 
products and related materials. These materials may include, but are 
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 sales of medical products, and consumer and professional 
education.
    In the Federal Register of July 17, 2019 (84 FR 34186), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Annually, we project that 20 studies will be initiated using 160 
focus groups with an average of 9 persons per group. We assume each 
focus group will last an average of 1.75 hours.
    We estimate the burden for the information collection 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Study..................................................           1,440                1            1,440             1.75            2,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28247 Filed 12-30-19; 8:45 am]
 BILLING CODE 4164-01-P