Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability, 70503-70504 [2021-26737]

Download as PDF jspears on DSK121TN23PROD with NOTICES1 Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices information submitted by States is reviewed and results are compiled by CMS in a format intended to provide information, comparisons, and trends related to States’ experiences with DUR. States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports. In this 2021 collection of information request, we revised certain FFS, MCO, and Abbreviated MCO survey questions. While a few questions were added to the surveys to address GAO (U.S. Government Accountability Office) recommendations, other aspects of the survey changes include grammar and formatting edits. Overall, we are not revising our currently approved burden estimates. Form Number: CMS–R–153 (OMB control number: 0938–0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 663; Total Annual Hours: 41,004. (For policy questions regarding this collection contact Mike Forman at 410–786–2666.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Supporting Statement for Essential Community Provider Data Collection to Support QHP Certification for PYs 2022–2024; Use: Standards for Essential Community Provider (ECP) requirements are codified at 45 CFR 156.235. Issuers must contract with a certain percentage, as determined by HHS, of the available ECPs in the plan’s service area. For plan years 2022–2024, Health and Human Services (HHS) will continue to solicit qualified ECPs to complete and submit the HHS ECP provider petition in order to be added to the HHS ECP list, or update required data fields to remain on the list, resulting in a more robust and accurate listing of the universe of available ECPs from which issuers select to satisfy the ECP standard. HHS will continue to collect such data directly from providers through the online ECP provider petition. Form Number: CMS– 10561; Frequency: Annually; Affected Public: Private sector, Business or other for-profits, and Not-for-profit Institutions; Number of Respondents: 12,408; Number of Responses: 12,408; Total Annual Hours: 3,140. (For questions regarding this collection, contact Deborah Hunter at 443–386– 3651). 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: The State VerDate Sep<11>2014 17:03 Dec 09, 2021 Jkt 256001 Flexibility to Stabilize the Market Cycle I and II Grant Program Reporting; Use: Section 1003 of the Affordable Care Act (ACA) adds a new section 2794 to the Public Health Service Act (PHS Act) entitled, ‘‘Ensuring That Consumers Get Value for Their Dollars.’’ Specifically, section 2794(a) requires the Secretary of the Department of Health and Human Services (the Secretary) (HHS), in conjunction with the States, to establish a process for the annual review of health insurance premiums to protect consumers from unreasonable rate increases. Section 2794(c) directs the Secretary to carry out a program to award grants to States. Section 2794(c)(2)(B) specifies that any appropriated Rate Review Grant funds that are not fully obligated by the end of FY 2014 shall remain available to the Secretary for grants to States for planning and implementing the insurance market reforms and consumer protections under Part A of title XXVII of the (PHS Act. States that are awarded funds under this funding opportunity are required to provide CMS with four quarterly reports and one annual report (except for the last year of the grant) until the end of the grant period detailing the state’s progression towards planning and/or implementing the preselected market reforms under Part A of Title XXVII of the PHS Act. A final report is due at the end of the grant period. Form Number: CMS–10657 (OMB control number: 0938–1366); Frequency: Annually and Quarterly; Affected Public: State, Local or Tribal Governments; Number of Respondents: 34; Total Annual Responses: 170; Total Annual Hours: 2,312. (For policy questions regarding this collection contact Jim Taing at James.Taing@ cms.hhs.gov.) 70503 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Development of Anti-Infective Drug Products for the Pediatric Population.’’ The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help facilitate pediatric anti-infective drug product development. This guidance finalizes the draft guidance of the same title issued on June 30, 2020. DATES: The announcement of the guidance is published in the Federal Register on December 10, 2021. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES 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’’). Food and Drug Administration Written/Paper Submissions [Docket No. FDA–2020–D–1518] 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 Dated: December 7, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–26816 Filed 12–9–21; 8:45 am] BILLING CODE 4120–01–P Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice of availability. Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 jspears on DSK121TN23PROD with NOTICES1 70504 Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices 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– 2020–D–1518 for ‘‘Development of AntiInfective Drug Products for the Pediatric Population.’’ 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-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 VerDate Sep<11>2014 17:03 Dec 09, 2021 Jkt 256001 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document. FOR FURTHER INFORMATION CONTACT: Hiwot Hiruy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–0872; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Development of Anti-Infective Drug Products for the Pediatric Population.’’ The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help facilitate pediatric anti-infective drug product development. This guidance finalizes the draft guidance of the same title issued on June 30, 2020 (85 FR 39193). FDA provided clarifying edits to the final guidance and included additional information after considering comments received on the draft guidance. Changes from the draft to the final guidance include updates to efficacy extrapolation from adult to pediatric patients (including from one pediatric subpopulation to another), safety data collection, additional considerations for studies, and recommendations for conducting juvenile toxicology studies. 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 ‘‘Development of Anti-Infective Drug Products for the Pediatric Population.’’ It does not establish any rights for any person and is not binding on FDA or the public. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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 parts 312 and 314 and 21 CFR 201.56 and 201.57 have been approved under OMB control numbers 0910–0014, 0910–0001, and 0910–0572, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https:// www.regulations.gov. Dated: December 6, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–26737 Filed 12–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0918] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, 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 January 10, 2022. SUMMARY: E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70503-70504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1518]


Development of Anti-Infective Drug Products for the Pediatric 
Population; 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 final guidance for industry entitled 
``Development of Anti-Infective Drug Products for the Pediatric 
Population.'' The purpose of this guidance is to provide general 
recommendations on the development of anti-infective drug products for 
pediatric patients. The guidance addresses enrollment strategies, 
extrapolation of efficacy, safety database, and other considerations to 
help facilitate pediatric anti-infective drug product development. This 
guidance finalizes the draft guidance of the same title issued on June 
30, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on December 10, 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

[[Page 70504]]

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-2020-D-1518 for ``Development of Anti-Infective Drug Products for 
the Pediatric Population.'' 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 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Hiwot Hiruy, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-0872; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Development of Anti-Infective Drug Products for the 
Pediatric Population.'' The purpose of this guidance is to provide 
general recommendations on the development of anti-infective drug 
products for pediatric patients. The guidance addresses enrollment 
strategies, extrapolation of efficacy, safety database, and other 
considerations to help facilitate pediatric anti-infective drug product 
development.
    This guidance finalizes the draft guidance of the same title issued 
on June 30, 2020 (85 FR 39193). FDA provided clarifying edits to the 
final guidance and included additional information after considering 
comments received on the draft guidance. Changes from the draft to the 
final guidance include updates to efficacy extrapolation from adult to 
pediatric patients (including from one pediatric subpopulation to 
another), safety data collection, additional considerations for 
studies, and recommendations for conducting juvenile toxicology 
studies.
    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 ``Development of Anti-Infective Drug 
Products for the Pediatric Population.'' 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 parts 312 and 314 and 21 CFR 201.56 and 201.57 
have been approved under OMB control numbers 0910-0014, 0910-0001, and 
0910-0572, respectively.

III. Electronic Access

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

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26737 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P
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