83 FR 30752 - Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 126 (June 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 126 (June 29, 2018)
| Page Range | 30752-30753 | |
| FR Document | 2018-14055 |
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)] [Notices] [Pages 30752-30753] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14055] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1772] Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.'' The purpose of this draft guidance is to assist sponsors in designing appropriate nonclinical studies before initiation of first-in-human (FIH) trials and through product approval. In addition, this draft guidance provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. This draft guidance intends to provide recommendations for nonclinical programs in a unique and challenging area of product development, provide a more consistent approach in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 DATES: Submit either electronic or written comments on the draft guidance by August 28, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2018-D-1772 for ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability.'' 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 [[Page 30753]] 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.thefederalregister.org/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. 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 draft guidance for industry entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.'' This draft guidance presents FDA's current thinking on nonclinical studies needed to support FIH studies and for approval for therapeutic radiopharmaceuticals. In this draft guidance, the term therapeutic radiopharmaceutical refers to a pharmaceutical that contains a radionuclide and is used in patients with cancer for the treatment or for palliation of tumor-related symptoms (e.g., pain). This draft guidance discusses the following concepts: (1) Evaluation of toxicities from the ligand; (2) evaluation of radiation toxicities; and (3) 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 supporting FIH trials and approval for radiopharmaceuticals for treatment of cancer. The guidance for industry entitled ``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 draft guidance provides further clarification of recommendations made in that guidance for the timing and design of late radiation toxicity studies. This draft guidance intends 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 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 nonclinical studies and labeling recommendations for oncology therapeutic radiopharmaceuticals. 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 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; and 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 draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: June 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14055 Filed 6-28-18; 8:45 am] BILLING CODE 4164-01-P
![30752 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
The Quality Metrics Site Visit DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Program does not supplement or replace HUMAN SERVICES confidential business information, such
a regulatory inspection (e.g., a as a manufacturing process. Please note
preapproval inspection, pre-license Food and Drug Administration that if you include your name, contact
inspection, or a surveillance [Docket No. FDA–2018–D–1772] information, or other information that
inspection). identifies you in the body of your
Oncology Therapeutic comments, that information will be
III. Site Selection Radiopharmaceuticals: Nonclinical posted on https://www.regulations.gov.
Studies and Labeling • If you want to submit a comment
Selection of potential facilities will be with confidential information that you
Recommendations; Draft Guidance for
based on the priorities developed for do not wish to be made available to the
Industry; Availability
CDER and CBER staff training, the public, submit the comment as a
facility’s current compliance status with AGENCY: Food and Drug Administration, written/paper submission and in the
FDA, and in consultation with the HHS. manner detailed (see ‘‘Written/Paper
appropriate FDA district office. All ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’).
travel expenses associated with this
SUMMARY: The Food and Drug Written/Paper Submissions
program will be the responsibility of
Administration (FDA or Agency) is Submit written/paper submissions as
FDA; therefore, selection will be based
announcing the availability of a draft follows:
on the availability of funds and
resources for the fiscal year. FDA will
guidance for industry entitled • Mail/Hand Delivery/Courier (for
‘‘Oncology Therapeutic written/paper submissions): Dockets
not provide financial compensation to Radiopharmaceuticals: Nonclinical Management Staff (HFA–305), Food and
the pharmaceutical site as part of this Studies and Labeling Drug Administration, 5630 Fishers
program. Recommendations.’’ The purpose of this Lane, Rm. 1061, Rockville, MD 20852.
IV. Proposals for Participation draft guidance is to assist sponsors in • For written/paper comments
designing appropriate nonclinical submitted to the Dockets Management
Companies interested in offering a site studies before initiation of first-in- Staff, FDA will post your comment, as
visit or learning more about this site human (FIH) trials and through product well as any attachments, except for
visit program should respond by approval. In addition, this draft information submitted, marked and
submitting a proposal directly to Tara guidance provides recommendations for identified, as confidential, if submitted
Gooen Bizjak or Stephen Ripley (see FOR product labeling, such as duration of as detailed in ‘‘Instructions.’’
FURTHER INFORMATION CONTACT). To aid contraception to minimize potential risk Instructions: All submissions received
in FDA’s site selection and planning, to a developing embryo/fetus and must include the Docket No. FDA–
your proposal should include the recommendations for lactating women 2018–D–1772 for ‘‘Oncology
following information: to minimize potential risk to a nursing Therapeutic Radiopharmaceuticals:
infant. This draft guidance intends to Nonclinical Studies and Labeling
• A contact person; provide recommendations for Recommendations; Draft Guidance for
• site visit location(s); nonclinical programs in a unique and Industry; Availability.’’ Received
• Facility Establishment Identifier challenging area of product comments will be placed in the docket
and Data Universal Numbering System development, provide a more consistent and, except for those submitted as
numbers, as applicable; approach in nonclinical studies and ‘‘Confidential Submissions,’’ publicly
product labeling, and reduce the viewable at https://www.regulations.gov
• maximum number of FDA staff that conduct of nonclinical studies that are or at the Dockets Management Staff
can be accommodated during a site visit not informative for product use. between 9 a.m. and 4 p.m., Monday
(maximum of 10), DATES: Submit either electronic or through Friday.
• a description of the development, written comments on the draft guidance • Confidential Submissions—To
history, and ongoing management of the by August 28, 2018 to ensure that the submit a comment with confidential
quality metrics program; Agency considers your comment on this information that you do not wish to be
draft guidance before it begins work on made publicly available, submit your
• a sample agenda outlining the comments only as a written/paper
the final version of the guidance.
proposed learning objectives and submission. You should submit two
ADDRESSES: You may submit comments
associated activities for the site visit; copies total. One copy will include the
and on any guidance at any time as follows:
information you claim to be confidential
• preferred dates for a quality metrics Electronic Submissions with a heading or cover note that states
site visit. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Proposals submitted without this following way: CONFIDENTIAL INFORMATION.’’ The
minimum information will not be • Federal eRulemaking Portal: Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
considered.
instructions for submitting comments. its consideration of comments. The
Dated: June 25, 2018. Comments submitted electronically, second copy, which will have the
Leslie Kux, including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
sradovich on DSK3GMQ082PROD with NOTICES
Associate Commissioner for Policy.
[FR Doc. 2018–14006 Filed 6–28–18; 8:45 am] the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
BILLING CODE 4164–01–P
solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
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![Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30753
in the body of your comments and you (e.g., pain). This draft guidance information in the ‘‘Content and Format
must identify this information as discusses the following concepts: (1) of Labeling for Human Prescription
‘‘confidential.’’ Any information marked Evaluation of toxicities from the ligand; Drug and Biological Products;
as ‘‘confidential’’ will not be disclosed (2) evaluation of radiation toxicities; Requirements for Pregnancy and
except in accordance with 21 CFR 10.20 and (3) information for product labeling Lactation Labeling’’ final rule has been
and other applicable disclosure law. For as related to reproductive toxicity, approved under OMB control number
more information about FDA’s posting genotoxicity, carcinogenicity, 0910–0624.
of comments to public dockets, see 80 contraception, and use in lactating
women. III. Electronic Access
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/ Currently, no FDA or International Persons with access to the internet
fdsys/pkg/FR-2015-09-18/pdf/2015- Council for Harmonisation guidance may obtain the draft guidance at either
23389.pdf. addresses nonclinical studies https://www.fda.gov/Drugs/Guidance
Docket: For access to the docket to supporting FIH trials and approval for ComplianceRegulatoryInformation/
read background documents or the radiopharmaceuticals for treatment of Guidances/default.htm or https://
electronic and written/paper comments cancer. The guidance for industry www.regulations.gov.
received, go to https:// entitled ‘‘Nonclinical Evaluation of Late Dated: June 26, 2018.
www.regulations.gov and insert the Radiation Toxicity of Therapeutic
Leslie Kux,
docket number, found in brackets in the Radiopharmaceuticals’’ (available at
https://www.fda.gov/downloads/Drugs/ Associate Commissioner for Policy.
heading of this document, into the
GuidanceComplianceRegulatory [FR Doc. 2018–14055 Filed 6–28–18; 8:45 am]
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management Information/Guidances/ BILLING CODE 4164–01–P
Staff, 5630 Fishers Lane, Rm. 1061, UCM079242.pdf) describes nonclinical
Rockville, MD 20852. studies to address late radiation toxicity
only. This draft guidance provides DEPARTMENT OF HEALTH AND
You may submit comments on any
further clarification of recommendations HUMAN SERVICES
guidance at any time (see 21 CFR
10.115(g)(5)). made in that guidance for the timing
and design of late radiation toxicity Food and Drug Administration
Submit written requests for single
copies of the draft guidance to the studies. This draft guidance intends to [Docket No. FDA–2018–N–0793]
Division of Drug Information, Center for bring consistency in nonclinical safety
assessment and in product labeling for Sun Pharmaceutical Industries, Ltd.,
Drug Evaluation and Research, Food
therapeutic radiopharmaceuticals and to and Sun Pharma Global FZE;
and Drug Administration, 10001 New
reduce the number of nonclinical Withdrawal of Approval of Four
Hampshire Ave., Hillandale Building,
studies that are not informative for Abbreviated New Drug Applications;
4th Floor, Silver Spring, MD 20993–
product use. Correction
0002. Send one self-addressed adhesive
label to assist that office in processing This draft guidance is being issued
consistent with FDA’s good guidance AGENCY: Food and Drug Administration,
your requests. See the SUPPLEMENTARY HHS.
INFORMATION section for electronic
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will ACTION: Notice; correction.
access to the draft guidance document.
represent the current thinking of FDA
FOR FURTHER INFORMATION CONTACT: SUMMARY: The Food and Drug
on nonclinical studies and labeling
Haleh Saber, Center for Drug Evaluation Administration (FDA) is correcting a
recommendations for oncology
and Research, Food and Drug therapeutic radiopharmaceuticals. It notice that appeared in the Federal
Administration, 10903 New Hampshire does not establish any rights for any Register on March 14, 2018. The notice
Ave., Bldg. 22, Rm. 2117, Silver Spring, person and is not binding on FDA or the announced the voluntary withdrawal of
MD 20993–0002, 301–796–7550, or John public. You can use an alternative approval of four abbreviated new drug
Leighton, Center for Drug Evaluation approach if it satisfies the requirements applications (ANDAs) from two
and Research, Food and Drug of the applicable statutes and applicants, effective April 13, 2018. In
Administration, 10903 New Hampshire regulations. This guidance is not subject particular, the notice indicated that FDA
Ave., Bldg. 22, Rm. 2204, Silver Spring, to Executive Order 12866. was withdrawing approval of the
MD 20993–0002, 301–796–7550. following ANDA after receiving a
SUPPLEMENTARY INFORMATION:
II. Paperwork Reduction Act of 1995 withdrawal request from Sun
This draft guidance refers to Pharmaceutical Industries, Ltd., c/o Sun
I. Background previously approved collections of Pharmaceutical Industries, Inc. (Sun
FDA is announcing the availability of information found in FDA regulations. Pharmaceutical), 2 Independence Way,
a draft guidance for industry entitled These collections of information are Princeton, NJ 08540: ANDA 076045,
‘‘Oncology Therapeutic subject to review by the Office of Lorazepam Tablets USP, 0.5 milligram
Radiopharmaceuticals: Nonclinical Management and Budget (OMB) under (mg), 1 mg, and 2 mg. Before withdrawal
Studies and Labeling the Paperwork Reduction Act of 1995 of this ANDA became effective,
Recommendations.’’ This draft guidance (44 U.S.C. 3501–3520). The collection of however, Sun Pharmaceutical informed
presents FDA’s current thinking on information in 21 CFR 312.23(a)(8) for FDA that it did not want approval of the
nonclinical studies needed to support submitting pharmacological and ANDA withdrawn. Because Sun
FIH studies and for approval for toxicology information has been Pharmaceutical timely requested that
sradovich on DSK3GMQ082PROD with NOTICES
therapeutic radiopharmaceuticals. In approved under OMB control number approval of this ANDA not be
this draft guidance, the term therapeutic 0910–0014; the collection of withdrawn, the approval of ANDA
radiopharmaceutical refers to a information in 21 CFR 201.56 and 076045 is still in effect.
pharmaceutical that contains a 201.57 for preparing human FOR FURTHER INFORMATION CONTACT:
radionuclide and is used in patients prescription drug labeling has been Trang Tran, Center for Drug Evaluation
with cancer for the treatment or for approved under OMB control number and Research, Food and Drug
palliation of tumor-related symptoms 0910–0572; and the collection of Administration, 10903 New Hampshire
VerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1](https://thefederalregister.org/doc/83_FR_30878/page/2.svg)
Document Created: 2018-06-29 01:14:06
Document Modified: 2018-06-29 01:14:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by August 28, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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. | |
| FR Citation | 83 FR 30752 |
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