Document ID: FDA-2019-D-3132-0001
Agency: fda
Document Type: Notice
Title: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Draft Guidance for Industry;  Availability
Posted Date: 2019-08-01T04:00Z

[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for Drugs and Biological Products; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``General 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 This draft guidance is intended to assist 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issuance of this draft guidance on clinical pharmacology considerations 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DATES: Submit either electronic or written comments on the draft 
guidance by October 30, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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