Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Draft Guidance for Industry, Revision 1; Availability, 77125-77126 [2022-27344]

Download as PDF 77125 Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices ANNUAL BURDEN ESTIMATES—Continued Instrument Instrument 14: BSC Teachers and Support Staff Focus Group Discussion Guide ............................... Instrument 15: BSC Parent Focus Group Discussion Guide ........................................................................ Instrument 16: Individual BSC Teams Focus Group Discussion Guide ..................................................... Instrument 17a: Administrator Surveys ....................... Instrument 17b: Teacher Surveys ............................... Instrument 17c: Other Center Staff Surveys ............... Instrument 17di: Non-BSC Parent Surveys ................. Instrument 17dii: BSC Parent Surveys ........................ Instrument 18: Classroom Observations ..................... Instrument 19: Administrative Data Survey ................. Estimated Total Annual Burden Hours: 2,770. Authority: Head Start Act 640 [42 U.S.C. 9835] and 649 [42 U.S.C. 9844]; appropriated by the Continuing Appropriations Act of 2019. Child Care and Development Block Grant Act of 1990 as amended by the CCDBG Act of 2014 (Public Law 113186). Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2022–27241 Filed 12–15–22; 8:45 am] BILLING CODE 4184–22–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0710] Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Draft Guidance for Industry, Revision 1; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. lotter on DSK11XQN23PROD with NOTICES1 20:05 Dec 15, 2022 Jkt 259001 Annual burden (in hours) 1.5 360 120 24 2 1.5 72 24 168 24 240 96 2136 24 48 24 2 3 3 3 2 3 3 4 1.5 0.5 0.5 0.5 0.25 0.5 0.33 0.25 504 36 360 144 1068 36 48 24 168 12 120 48 356 12 16 8 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 Frm 00069 Total burden (in hours) 2 inspection. This draft guidance describes, for both drugs and now devices, the types of behaviors (actions, inactions, and circumstances) that the FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. Once finalized, this draft guidance is intended to supersede the October 2014 FDA final guidance for industry entitled, ‘‘Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.’’ However, until this draft guidance is finalized, the October 2014 FDA guidance remains in effect until it is withdrawn and will continue to reflect FDA’s current thinking on this issue. FDA is particularly interested in comments on the inclusion of devices to the October 2014 guidance. DATES: Submit either electronic or written comments on the draft guidance by February 14, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: PO 00000 Avg. burden per response (in hours) 120 Electronic Submissions The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled, ‘‘Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.’’ The FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case with a drug, a device is deemed to be adulterated if the owner, operator, or agent of the factory, warehouse, or establishment at which the device is manufactured, processed, packed, or held delays, denies, or limits an FDA SUMMARY: VerDate Sep<11>2014 Number of responses per respondent (total over request period) Number of respondents (total over request period) Fmt 4703 Sfmt 4703 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– 2013–D–0710 for ‘‘Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.’’ Received comments 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, 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 E:\FR\FM\16DEN1.SGM 16DEN1 77126 Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices 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 a single hard copy of the draft guidance to the Division of Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Drive, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Lola Burford, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20857, Lola.Burford@ fda.hhs.gov, 240–402–5865. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 FOR FURTHER INFORMATION CONTACT: I. Background On July 9, 2012, the Food and Drug Administration Safety and Innovation VerDate Sep<11>2014 20:05 Dec 15, 2022 Jkt 259001 Act (FDASIA) (Pub. L. 112–144) added section 501(j) to the FD&C Act (21 U.S.C. 351(j)) to deem adulterated a drug that ‘‘has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.’’ Section 707(b) of FDASIA required the Food and Drug Administration to issue guidance that defined the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the FD&C Act. In the Federal Register of October 22, 2014 (79 FR 63130), FDA announced the availability of a guidance for industry entitled, ‘‘Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection’’ (hereinafter, 2014 guidance). Subsequently, on August 18, 2017, FDARA (Pub. L. 115–52) was signed into law. Section 702 of FDARA amended the scope of section 501(j) of the FD&C Act to provide that, as the case with drugs, devices are deemed to be adulterated if an FDA inspection is delayed, denied, limited, or refused by the owner, operator, or agent of the establishment at which the device is manufactured, processed, packed, or held. This draft guidance is intended to update the 2014 final guidance to incorporate devices and to explain the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, resulting in a drug or device manufactured in the facility being deemed adulterated. The 2014 guidance will remain in effect and will continue to reflect FDA’s current thinking regarding circumstances that would constitute delaying, deny, or limiting inspection, or refusing to permit entry or inspection, for purposes of 501(j) of the FD&C Act with respect to drug inspections, until this draft guidance is finalized. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection’’ and will supersede the 2014 guidance. 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. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/searchgeneral-and-cross-cutting-topicsguidance-documents, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection’’ may send an email request to ORAPolicyStaffs@fda.hhs.gov to receive an electronic copy of the document. Dated: December 13, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27344 Filed 12–15–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1206] Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice correction that appeared in the Federal Register of August 20, 2020. The document announced the correction dates that the support and requirement were to begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), and version 3.3 of the SDTM Implementation Guide (SDTMIG), and for version 2.1 of the Define-Extensible Markup Language (Define-XML). The document erroneously provided the SUMMARY: E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77125-77126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27344]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0710]


Circumstances That Constitute Delaying, Denying, Limiting, or 
Refusing a Drug or Device Inspection; Draft Guidance for Industry, 
Revision 1; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled, ``Circumstances that 
Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device 
Inspection.'' The FDA Reauthorization Act of 2017 (FDARA) amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case 
with a drug, a device is deemed to be adulterated if the owner, 
operator, or agent of the factory, warehouse, or establishment at which 
the device is manufactured, processed, packed, or held delays, denies, 
or limits an FDA inspection. This draft guidance describes, for both 
drugs and now devices, the types of behaviors (actions, inactions, and 
circumstances) that the FDA considers to constitute delaying, denying, 
or limiting inspection, or refusing to permit entry or inspection. Once 
finalized, this draft guidance is intended to supersede the October 
2014 FDA final guidance for industry entitled, ``Circumstances that 
Constitute Delaying, Denying, Limiting, or Refusing a Drug 
Inspection.'' However, until this draft guidance is finalized, the 
October 2014 FDA guidance remains in effect until it is withdrawn and 
will continue to reflect FDA's current thinking on this issue. FDA is 
particularly interested in comments on the inclusion of devices to the 
October 2014 guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by February 14, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2013-D-0710 for ``Circumstances that Constitute Delaying, Denying, 
Limiting, or Refusing a Drug or Device Inspection.'' Received comments 
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, 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

[[Page 77126]]

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-2015-09-18/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 a single hard copy of the draft 
guidance to the Division of Operational Policy, Office of Regulatory 
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn 
Drive, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Lola Burford, Office of Regulatory 
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn 
Dr., Rockville, MD 20857, [email protected], 240-402-5865.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144) added section 501(j) to the 
FD&C Act (21 U.S.C. 351(j)) to deem adulterated a drug that ``has been 
manufactured, processed, packed, or held in any factory, warehouse, or 
establishment and the owner, operator, or agent of such factory, 
warehouse, or establishment delays, denies, or limits an inspection, or 
refuses to permit entry or inspection.'' Section 707(b) of FDASIA 
required the Food and Drug Administration to issue guidance that 
defined the circumstances that would constitute delaying, denying, or 
limiting inspection, or refusing to permit entry or inspection, for 
purposes of section 501(j) of the FD&C Act. In the Federal Register of 
October 22, 2014 (79 FR 63130), FDA announced the availability of a 
guidance for industry entitled, ``Circumstances that Constitute 
Delaying, Denying, Limiting, or Refusing a Drug Inspection'' 
(hereinafter, 2014 guidance).
    Subsequently, on August 18, 2017, FDARA (Pub. L. 115-52) was signed 
into law. Section 702 of FDARA amended the scope of section 501(j) of 
the FD&C Act to provide that, as the case with drugs, devices are 
deemed to be adulterated if an FDA inspection is delayed, denied, 
limited, or refused by the owner, operator, or agent of the 
establishment at which the device is manufactured, processed, packed, 
or held. This draft guidance is intended to update the 2014 final 
guidance to incorporate devices and to explain the circumstances that 
FDA would consider to constitute delaying, denying, or limiting 
inspection, or refusing to permit entry or inspection, resulting in a 
drug or device manufactured in the facility being deemed adulterated. 
The 2014 guidance will remain in effect and will continue to reflect 
FDA's current thinking regarding circumstances that would constitute 
delaying, deny, or limiting inspection, or refusing to permit entry or 
inspection, for purposes of 501(j) of the FD&C Act with respect to drug 
inspections, until this draft guidance is finalized.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Circumstances that Constitute Delaying, Denying, Limiting, or 
Refusing a Drug or Device Inspection'' and will supersede the 2014 
guidance. 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

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Circumstances that Constitute Delaying, 
Denying, Limiting, or Refusing a Drug or Device Inspection'' may send 
an email request to [email protected] to receive an 
electronic copy of the document.

    Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27344 Filed 12-15-22; 8:45 am]
BILLING CODE 4164-01-P

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