Notice2022-16076
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Guidance for Industry; Availability
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Published
July 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products." This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations. This guidance finalizes the draft guidance of the same title issued on August 1, 2019.
Full Text
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<title>Federal Register, Volume 87 Issue 143 (Wednesday, July 27, 2022)</title>
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[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45110-45111]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16076]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3132]
General Clinical Pharmacology Considerations for Neonatal Studies
for Drugs and Biological Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``General
Clinical Pharmacology Considerations for Neonatal Studies for Drugs and
Biological Products.'' This guidance is intended to assist sponsors of
investigational new drug applications (INDs) and applicants of new drug
applications (NDAs), biologics license applications (BLAs), and
supplements to such applications who are planning to conduct clinical
studies in neonatal populations. This guidance finalizes the draft
guidance of the same title issued on August 1, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on July 27, 2022.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-D-3132 for ``General Clinical Pharmacology Considerations for
Neonatal Studies for Drugs and Biological Products.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 to 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: Elimika Pfuma Fletcher, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2162, Silver Spring, MD 20993, 301-796-
3473, <a href="/cdn-cgi/l/email-protection#47022b2e2a2e2c2669012b2233242f223507212326692f2f3469202831"><span class="__cf_email__" data-cfemail="13567f7a7e7a78723d557f7667707b7661537577723d7b7b603d747c65">[email protected]</span></a> 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, 240-
402-7911, <a href="/cdn-cgi/l/email-protection#b4e7c0d1c4dcd1da9ae6ddc4d8d1cdf4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="b2e1c6d7c2dad7dc9ce0dbc2ded7cbf2d4d6d39cdadac19cd5ddc4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
``General Clinical Pharmacology Considerations for Neonatal Studies for
Drugs and Biological Products.'' This guidance is intended to assist
sponsors of INDs and applicants of NDAs, BLAs, and supplements to such
applications who are planning to conduct clinical studies in neonatal
populations.
In 2012, the Best Pharmaceuticals for Children Act (Pub. L. 107-
109) (BPCA)
[[Page 45111]]
and the Pediatric Research Equity Act (Pub. L. 108-155) were made
permanent under Title V of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144) (FDASIA). FDASIA requires that all
BPCA requests for pediatric drug studies include a rationale for not
including neonatal studies if none are requested.
Given that most drugs used in neonatal intensive care units (NICUs)
are used in an off-label capacity, it is important that drug
information be obtained in neonates to address gaps in neonatal
labeling. In addition, therapies need to be developed for conditions
unique to neonates. New approaches to the study of drugs in neonates
should consider the diversity of the patient population and underlying
conditions that are cared for in NICUs. Therefore, this guidance
addresses subgroup classifications of neonates; general
pharmacokinetic, pharmacodynamic, and pharmacogenomic considerations
for clinical pharmacology studies in neonates; and clinical
pharmacology considerations for planned studies in neonates.
This guidance finalizes the draft guidance entitled ``General
Clinical Pharmacology Considerations for Neonatal Studies for Drugs and
Biological Products'' issued on August 1, 2019 (84 FR 37653). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include the
addition of a section addressing immunogenicity, additional text
regarding consideration of the total volume administered to neonates,
and additional clarity regarding the use of microsampling methodology.
In addition, editorial changes were made to improve clarity.
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 ``General Clinical Pharmacology
Considerations for Neonatal Studies for Drugs and Biological
Products.'' 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
refers to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (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 institutional review boards in 21 CFR part 56
have been approved under OMB control number 0910-0130. The collections
of information in 21 CFR part 314 for the submission of new drug
applications have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 601 for the submission of
biologics license applications have been approved under OMB control
number 0910-0338. The collections of information 21 CFR part 312 for
the submission of investigational new drug applications have been
approved under OMB control number 0910-0014. The collections of
information in Sec. Sec. 312.47 and 312.82 for requesting meetings
with FDA about drug development programs have been approved under OMB
control number 0910-0429. The collections of information for the
submission of prescription drug labeling in 21 CFR 201.56 and 21 CFR
201.57 have been approved under OMB control number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.regulations.gov">https://www.regulations.gov</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>.
Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16076 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P
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