Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 26046-26047 [2021-09968]

Download as PDF 26046 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices antibacterial and antifungal drugs for human use to treat serious or lifethreatening infections. The primary incentive contained in GAIN is a 5-year extension of exclusivity for which a QIDP-designated application qualifies upon approval under the FD&C Act. QIDPs also receive fast-track designation at the sponsor’s request (21 U.S.C. 356(b)(1)), and the first marketing application submitted for approval of a QIDP is granted priority review (21 U.S.C. 360n–1). This guidance provides information about how FDA generally intends to implement GAIN and responses to common questions that might arise about QIDP designation and review of new drug applications for QIDPs. This guidance finalizes the draft guidance of the same name issued on January 30, 2018 (83 FR 4216). Based on the comments submitted to the docket on the draft guidance, FDA made clarifying changes to this guidance, including further information on what drug products the Agency generally intends to consider to be an antibacterial or antifungal drug for the purposes of QIDP designation. The Agency also provided clarification about when a sponsor should submit a new request for QIDP designation and what information should be included in a QIDP designation request. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on QIDP designation. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: May 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–09986 Filed 5–11–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0074] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications AGENCY: Food and Drug Administration, HHS. ACTION: 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 (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by June 11, 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 SUMMARY: 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 0910–0275. 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: State Enforcement Notifications—21 CFR 100.2(d) OMB Control Number 0910–0275— Extension This information collection supports Agency regulations. Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain sections of the FD&C Act in its own name and within its own jurisdiction. However, before doing so, a State must provide notice to FDA according to § 100.2 (21 CFR 100.2). The information required in a letter of notification under § 100.2(d) enables us to identify the food against which a State intends to take action and to advise that State whether Federal enforcement action against the food has been taken or is in process. With certain narrow exceptions, Federal enforcement action precludes State action under the FD&C Act. In the Federal Register of December 17, 2020 (85 FR 81932), 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: khammond on DSKJM1Z7X2PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 100.2(d) ................................................................................ 1 1 1 10 10 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 VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 OMB approval, we have made no adjustments to our burden estimate. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 The estimated reporting burden for § 100.2(d) is minimal because E:\FR\FM\12MYN1.SGM 12MYN1 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices enforcement notifications are seldom used by States. During the last 3 years, we have not received any new enforcement notifications; therefore, we estimate that one or fewer notifications will be submitted annually. Although we have not received any new enforcement notifications in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing us when it intends to take enforcement action under the FD&C Act against a particular food located in the State. Dated: May 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–09968 Filed 5–11–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6113] E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.’’ The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance clarifies, updates, and extends the guidance for industry ‘‘E9 Statistical Principles for Clinical Trials’’ issued in September 1998 in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The guidance is intended to better align the choice of statistical methods with questions of regulatory importance and khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 so to improve the reliability of decisions about and representations of the effects of medical products. The guidance replaces the draft guidance issued on October 31, 2017. DATES: The announcement of the guidance is published in the Federal Register on May 12, 2021. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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 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– 2017–D–6113 for ‘‘E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.’’ Received comments will be placed in the docket and, except for those submitted as PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 26047 ‘‘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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive E:\FR\FM\12MYN1.SGM 12MYN1

Agencies

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26046-26047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0074]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; State Enforcement 
Notifications

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 June 11, 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 0910-0275. 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.

State Enforcement Notifications--21 CFR 100.2(d)

OMB Control Number 0910-0275--Extension

    This information collection supports Agency regulations. 
Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain 
sections of the FD&C Act in its own name and within its own 
jurisdiction. However, before doing so, a State must provide notice to 
FDA according to Sec.  100.2 (21 CFR 100.2). The information required 
in a letter of notification under Sec.  100.2(d) enables us to identify 
the food against which a State intends to take action and to advise 
that State whether Federal enforcement action against the food has been 
taken or is in process. With certain narrow exceptions, Federal 
enforcement action precludes State action under the FD&C Act.
    In the Federal Register of December 17, 2020 (85 FR 81932), 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
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d)...........................................................               1                1                1               10               10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
    The estimated reporting burden for Sec.  100.2(d) is minimal 
because

[[Page 26047]]

enforcement notifications are seldom used by States. During the last 3 
years, we have not received any new enforcement notifications; 
therefore, we estimate that one or fewer notifications will be 
submitted annually. Although we have not received any new enforcement 
notifications in the last 3 years, we believe these information 
collection provisions should be extended to provide for the potential 
future need of a State government to submit enforcement notifications 
informing us when it intends to take enforcement action under the FD&C 
Act against a particular food located in the State.

    Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09968 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P


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