[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Notices]
[Pages 37653-37655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16375]
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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for Drugs and Biological Products; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``General
Clinical Pharmacology Considerations for Neonatal Studies for Drugs and
Biological Products.'' This draft guidance is intended to assist
sponsors of new drug applications (NDAs), biologics license
applications (BLAs) for therapeutic biologics, and supplements who are
planning to conduct clinical studies in neonatal populations. The
issuance of this draft guidance on clinical pharmacology considerations
for neonatal studies for drugs and biological products is stipulated
under the FDA Reauthorization Act of 2017 (FDARA).
DATES: Submit either electronic or written comments on the draft
guidance by October 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-
[[Page 37654]]
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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
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.gpo.gov/fdsys/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.
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 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Rajnikanth Madabushi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2173, Silver Spring, MD 20993, 301-796-
1537 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``General Clinical Pharmacology Considerations for Neonatal
Studies for Drugs and Biological Products.'' This draft guidance is
intended to assist sponsors of NDAs, BLAs for therapeutic biologics,
and supplements who are planning to conduct clinical studies in
neonatal populations. This draft guidance is adjunctive to the December
2014 draft FDA guidance entitled General Clinical Pharmacology
Considerations for Pediatric Studies for Drugs and Biological Products,
as it addresses general clinical pharmacology considerations in
neonates, a pediatric subpopulation. The issuance of this draft
guidance on clinical pharmacology considerations for neonatal studies
for drugs and biological products is stipulated under section 505 of
FDARA.
Given that most drugs used in Neonatal Intensive Care Units are
used in an off-label capacity, studies of therapeutic products need to
be conducted in neonates. In addition, therapies need to be developed
for conditions unique to neonates. This draft guidance addresses: (1)
Subgroup classifications of neonates; (2) general pharmacokinetic,
pharmacodynamic, and pharmacogenomic considerations for clinical
pharmacology studies in neonates; and (3) clinical pharmacology
considerations for any planned studies in neonates whether the studies
are conducted pursuant to the Best Pharmaceuticals for Children Act,
the Pediatric Research Equity Act, or neither. This draft guidance does
not discuss the timing to initiate neonatal studies. Questions
regarding the appropriate timing for the initiation of neonatal studies
should be discussed with the relevant FDA review division.
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 ``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. This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information for submitting of NDAs in 21 CFR
314.50(d)(7), including pediatric use information and the submission of
waiver requests in Sec. 314.90, have been approved under OMB control
number 0910-0001. The collections of information for submitting BLAs,
including pediatric use information and waiver requests under 21 CFR
601.27, have been approved under OMB control number 0910-0338. The
collections of information for submitting investigational new drug
applications in Sec. 312.47(b)(1)(iv), including plans for pediatric
studies and the submission of waiver requests in Sec. 312.10, have
been approved under OMB control number 0910-0014. The collections of
information for requesting meetings with FDA about drug development
programs in Sec. Sec. 312.47 and 312.82 have been approved under OMB
control number 0910-0014. The collections of information for
prescription drug labeling in 21 CFR 201.56 and 21 CFR 201.57 have been
approved under OMB control number 0910-0572. The collections of
information related to expedited review programs for serious conditions
have been approved under OMB control number 0910-0765.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov. Guidance documents are also available at
https://
[[Page 37655]]
www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-
information-biologics or http://www.regulations.gov.
Dated: July 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16375 Filed 7-31-19; 8:45 am]
BILLING CODE 4164-01-P