87 FR 143 pgs. 45110-45111 - General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Guidance for Industry; Availability
Type: NOTICEVolume: 87Number: 143Pages: 45110 - 45111
Pages: 45110, 45111Docket number: [Docket No. FDA-2019-D-3132]
FR document: [FR Doc. 2022-16076 Filed 7-26-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 This guidance finalizes the draft guidance of the same title issued on August 1, 2019.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:
• 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-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, 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 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, Elimika.Fletcher@fda.hhs.gov 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, Stephen.Ripley@fda.hhs.gov.
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.
[top] In 2012, the Best Pharmaceuticals for Children Act (Pub. L. 107-109) (BPCA)
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 §§?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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.regulations.gov, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.
Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16076 Filed 7-26-22; 8:45 am]
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