Acromegaly: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 5891-5892 [2023-01766]

Download as PDF 5891 Federal Register / Vol. 88, No. 19 / Monday, January 30, 2023 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents Activity/21 CFR or FD&C Act section Number of responses per respondent Average burden per response (hours) Total annual responses Total hours Subpart E—Postapproval Requirements: Postapproval requirements (814.82(a)(9)) ................................... Periodic reports (814.84(b)) .......................................................... 121 764 1 1 121 764 135 .................................. 10 .................................... 16,335 7,640 Total Subpart E ..................................................................... ........................ ........................ ........................ ......................................... 24,005 42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ‘‘Form FDA 3674—Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions’’ Certification to accompany PMA submissions (Form FDA 3674) ....... 40 1 40 0.75 (45 minutes) ........... 30 FD&C Act section 515A Pediatric Uses of Devices: Pediatric information in a PMA, PDP, or PMA supplement ................ Pediatric use information outside approved indication ........................ 944 800 1 1 944 800 2.10 ................................. 0.5 (30 minutes) ............. 1984 400 Subtotal .................................................................................. 1,744 1 1,744 ......................................... 2,384 Premarket Approval Submissions (eSTAR preparation; eCopy submission): eSTAR setup ........................................................................................ 30 1 30 0.08 (5 minutes) ............. 2 Total ................................................................................ ........................ ........................ ........................ ......................................... 343,496 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimate is based on the annual rate of receipt of PMA submissions, including PDPs and PMA supplements, for fiscal years 2019 through 2021 and our expectation of submissions to come in the next few years. We also account for referrals of PMAs to a panel for review, as provided for under § 814.44(a). FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. We have adjusted our figures to reflect an overall decrease, which we attribute to respondents’ use of modernized submission technologies including eSTAR. At the same time, we include in our estimate an initial burden attributable to respondents who need to set up an eSTAR account for the first time. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity/21 CFR section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Maintenance of records (814.82(a)(5) and (a)(6)) ............... 552 1 552 17 9,384 lotter on DSK11XQN23PROD with NOTICES1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The regulations require the maintenance of records, which are used to trace patients, and the organization and indexing of records into identifiable files to ensure a device’s continued safety and effectiveness. These records are required of all applicants who have an approved PMA. Currently there are 815 active PMAs that could be subject to these requirements, based on FDA data, and approximately 33 new PMAs are approved each year. We estimate our annual recordkeeping burden based on an average of 552 PMA holders. The applicant determines which records should be maintained during product development to document and/or substantiate the device’s safety and effectiveness. Records required under 21 CFR part 820 may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of VerDate Sep<11>2014 17:30 Jan 27, 2023 Jkt 259001 approval to ensure the device’s continuing safety and effectiveness. Cumulatively, our adjustments reflect only a slight increase to the estimated burden for the information collection. Dated: January 25, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–01849 Filed 1–27–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–2658] Acromegaly: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Acromegaly: Developing Drugs for Treatment.’’ The purpose of this guidance is to provide recommendations to sponsors regarding clinical development of drugs for the treatment of patients with acromegaly. This draft guidance is intended to serve as a focus for continued discussions among the FDA Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public. DATES: Submit either electronic or written comments on the draft guidance by March 31, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. SUMMARY: E:\FR\FM\30JAN1.SGM 30JAN1 5892 Federal Register / Vol. 88, No. 19 / Monday, January 30, 2023 / Notices You may submit comments on any guidance at any time as follows: ADDRESSES: lotter on DSK11XQN23PROD with NOTICES1 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– 2022–D–2658 for ‘‘Acromegaly: Developing Drugs for Treatment.’’ 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 submission. You should submit two copies total. One copy will include the VerDate Sep<11>2014 17:30 Jan 27, 2023 Jkt 259001 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 the draft 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Naomi Lowy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–0692. SUPPLEMENTARY INFORMATION: guidance is to provide recommendations to sponsors regarding clinical development of drugs for the treatment of patients with acromegaly. This draft guidance is intended to serve as a focus for continued discussions among the FDA Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public. 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 ‘‘Acromegaly: Developing Drugs for Treatment.’’ 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. I. Background Dated: January 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. FDA is announcing the availability of a draft guidance for industry entitled ‘‘Acromegaly: Developing Drugs for Treatment.’’ The purpose of this PO 00000 Frm 00043 Fmt 4703 Sfmt 9990 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 related to the submission of new drug applications and abbreviated new drug applications under 21 CFR part 314 have been approved under OMB control number 0910–0001. The collections of information related to the submission of investigational new drug applications under 21 CFR part 312 have been approved under OMB control number 0910–0014. The collections of information related to the submission of biologics license applications under 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. [FR Doc. 2023–01766 Filed 1–27–23; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5891-5892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2658]


Acromegaly: Developing Drugs for Treatment; Draft Guidance for 
Industry; 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 for industry entitled 
``Acromegaly: Developing Drugs for Treatment.'' The purpose of this 
guidance is to provide recommendations to sponsors regarding clinical 
development of drugs for the treatment of patients with acromegaly. 
This draft guidance is intended to serve as a focus for continued 
discussions among the FDA Division of General Endocrinology, 
pharmaceutical sponsors, the academic community, and the public.

DATES: Submit either electronic or written comments on the draft 
guidance by March 31, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

[[Page 5892]]


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-2022-D-2658 for ``Acromegaly: Developing Drugs for Treatment.'' 
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 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 single copies of the draft 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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Naomi Lowy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-0692.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Acromegaly: Developing Drugs for Treatment.'' The purpose of 
this guidance is to provide recommendations to sponsors regarding 
clinical development of drugs for the treatment of patients with 
acromegaly. This draft guidance is intended to serve as a focus for 
continued discussions among the FDA Division of General Endocrinology, 
pharmaceutical sponsors, the academic community, and the public.
    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 ``Acromegaly: 
Developing Drugs for Treatment.'' 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 related to the submission of new drug applications and 
abbreviated new drug applications under 21 CFR part 314 have been 
approved under OMB control number 0910-0001. The collections of 
information related to the submission of investigational new drug 
applications under 21 CFR part 312 have been approved under OMB control 
number 0910-0014. The collections of information related to the 
submission of biologics license applications under 21 CFR part 601 have 
been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01766 Filed 1-27-23; 8:45 am]
BILLING CODE 4164-01-P
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