[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37881-37882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1772]


Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies 
and Labeling Recommendations; 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 ``Oncology 
Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling 
Recommendations.'' The purpose of this guidance is to assist sponsors 
in designing appropriate nonclinical studies before initiation of 
first-in-human (FIH) trials and through product approval. In addition, 
this guidance provides recommendations for product labeling, such as 
duration of contraception to minimize potential risk to a developing 
embryo or fetus, and recommendations for lactating women to minimize 
potential risk to a nursing child. This guidance is intended to provide 
recommendations for nonclinical programs in a unique and challenging 
area of product development, provide a more consistent approach in 
nonclinical studies and product labeling, and reduce the conduct of 
nonclinical studies that are not informative for product use.

DATES: The announcement of the guidance is published in the Federal 
Register on August 2, 2019.

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-2018-D-1772 for ``Oncology Therapeutic Radiopharmaceuticals: 
Nonclinical Studies and Labeling Recommendations.'' 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

[[Page 37882]]

Drug Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, 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: Haleh Saber, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2117, Silver Spring, MD 20993-0002, 301-
796-7550; or John Leighton, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
2204, Silver Spring, MD 20993-0002, 301-796-7550.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical 
Studies and Labeling Recommendations.'' This guidance represents FDA's 
current thinking on nonclinical studies needed in support of FIH 
studies and for approval for therapeutic radiopharmaceuticals. 
Therapeutic radiopharmaceutical refers to a pharmaceutical that 
contains a radionuclide and is used in patients with cancer to treat 
the disease or palliate tumor-related symptoms (e.g., pain). This 
guidance discusses the following concepts: Evaluation of toxicities 
from the ligand; evaluation of radiation toxicities; and information 
for product labeling as related to reproductive toxicity, genotoxicity, 
carcinogenicity, contraception, and use in lactating women.
    Currently, no FDA or International Council for Harmonisation 
guidance addresses nonclinical studies in support of FIH trials and 
approval for radiopharmaceuticals for treatment of cancer. The guidance 
for industry ``Nonclinical Evaluation of Late Radiation Toxicity of 
Therapeutic Radiopharmaceuticals'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079242.pdf) describes nonclinical studies to address late radiation 
toxicity only. This guidance, however, provides further clarification 
of recommendations made in that guidance for the timing and design of 
late radiation toxicity studies. This guidance is intended to bring 
consistency in nonclinical safety assessment and in product labeling 
for therapeutic radiopharmaceuticals and to reduce the number of 
nonclinical studies that are not informative for product use.
    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 ``Oncology Therapeutic Radiopharmaceuticals: 
Nonclinical Studies and Labeling Recommendations.'' 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 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 
collection of information in 21 CFR 312.23(a)(8) for submitting 
pharmacological and toxicology information has been approved under OMB 
control number 0910-0014; the collection of information in 21 CFR 
201.56 and 201.57 for preparing human prescription drug labeling has 
been approved under OMB control number 0910-0572; the collection of 
information in the ``Content and Format of Labeling for Human 
Prescription Drug and Biological Products; Requirements for Pregnancy 
and Lactation Labeling'' final rule has been approved under OMB control 
number 0910-0624.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16504 Filed 8-1-19; 8:45 am]
 BILLING CODE 4164-01-P


