82 FR 45593 - Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 188 (September 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45593-45594 | |
| FR Document | 2017-20906 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Notices] [Pages 45593-45594] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20906] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-2165] Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.'' The purpose of this guidance is to assist sponsors in reproductive toxicity assessments (mainly of embryo-fetal development) for oncology pharmaceuticals and to provide recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo/fetus. The guidance also clarifies FDA's current thinking on when nonclinical studies for reproductive toxicology assessment may not be needed (e.g., for pharmaceuticals intended for use in postmenopausal women only). The intended outcome of this guidance is to provide for more consistent labeling for oncology pharmaceuticals and to reduce the conduct of nonclinical studies that are not informative on product use. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 28, 2017. ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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 45594]] 2017-D-2165 for ``Oncology Pharmaceuticals: Reproductive Toxicity Testing 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 Division of Dockets Management 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 Division of Dockets Management. 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.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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: 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- 796-0750; or 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, 301-796-0750. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.'' This guidance presents FDA's current approach to assessing potential risks to embryo-fetal development associated with oncology pharmaceutical use in male and female patients. The term pharmaceutical in this guidance refers to small molecules, therapeutic proteins, antibodies, and related products such as conjugated products. The guidance describes when embryo-fetal developmental studies for oncology pharmaceuticals may be warranted for different types of pharmaceuticals, such as cytotoxic, biological, and conjugated pharmaceuticals, or pharmaceuticals used in combinations. The guidance also discusses other aspects of a nonclinical reproductive toxicity evaluation, such as fertility and pre- and postnatal evaluation. The guidance addresses the need for a reproductive toxicity evaluation when pharmaceuticals are used in specific populations (e.g., pediatric, males-only, or postmenopausal women). Although current regulatory guidances exist regarding the need to assess the embryo-fetal developmental toxicity potential of pharmaceuticals and the overall design of the studies, this guidance provides additional recommendations on specific types of products and for specific populations, which are not covered under other guidances. In addition, this guidance provides recommendations on the use of contraception and the duration of its use to minimize the potential risks associated with the use of oncology pharmaceuticals. 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 reproductive toxicity testing and labeling recommendations for oncology pharmaceuticals. 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 is not a significant regulatory action subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The collections of information in 21 CFR 201.56, 201.57, and the final rule ``Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling'' have been approved under OMB control numbers 0910-0572 and 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: September 22, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20906 Filed 9-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45593
reconsideration determination, a right to annually, beginning in January 2005, by over the initial threshold amount of
an ALJ hearing if the amount remaining the percentage increase in the medical $100 established in 2003. In accordance
in controversy after the IRE care component of the CPI for all urban with section 1869(b)(1)(E)(iii) of the Act,
reconsideration meets the threshold consumers (U.S. city average) for July the adjusted threshold amounts are
amount established annually by the 2003 to July of the year preceding the rounded to the nearest multiple of $10.
Secretary. Sections 423.1976(a) and (b) year involved and rounded to the Therefore, the CY 2018 AIC threshold
allow a Part D enrollee to request nearest multiple of $10. amount for ALJ hearings is $160.00. The
judicial review of an ALJ or Medicare AIC threshold amount for judicial
B. Calendar Year 2018
Appeals Council decision if, in part, the review changes to $1,599.89 based on
AIC meets the threshold amount The AIC threshold amount for ALJ the 59.989 percent increase over the
established annually by the Secretary. hearings will remain at $160 and the initial threshold amount of $1,000. This
AIC threshold amount for judicial amount was rounded to the nearest
II. Provisions of the Notice—Annual review will rise to $1,600 for CY 2018. multiple of $10, resulting in the CY
AIC Adjustments These amounts are based on the 59.989 2018 AIC threshold amount of $1,600.00
A. AIC Adjustment Formula and AIC percent increase in the medical care for judicial review.
Adjustments component of the CPI, which was at
297.600 in July 2003 and rose to 476.130 C. Summary Table of Adjustments in
As previously noted, section 940 of in July 2017. The AIC threshold amount the AIC Threshold Amounts
the MMA requires that the AIC for ALJ hearings changes to $159.99 In the following table we list the CYs
threshold amounts be adjusted based on the 59.989 percent increase 2014 through 2018 threshold amounts.
CY 2014 CY 2015 CY 2016 CY 2017 CY 2018
ALJ Hearing ............................................................................................. $140 $150 $150 $160 $160
Judicial Review ........................................................................................ 1,430 1,460 1,500 1,560 1,600
III. Collection of Information purpose of this guidance is to assist posted to the docket unchanged.
Requirements sponsors in reproductive toxicity Because your comment will be made
This document does not impose assessments (mainly of embryo-fetal public, you are solely responsible for
information collection requirements, development) for oncology ensuring that your comment does not
that is, reporting, recordkeeping or pharmaceuticals and to provide include any confidential information
third-party disclosure requirements. recommendations for product labeling that you or a third party may not wish
Consequently, there is no need for on duration of contraception following to be posted, such as medical
review by the Office of Management and cessation of therapy to minimize information, your or anyone else’s
Budget under the authority of the potential risk to a developing embryo/ Social Security number, or confidential
Paperwork Reduction Act of 1995 (44 fetus. The guidance also clarifies FDA’s business information, such as a
U.S.C. 3501 et seq.). current thinking on when nonclinical manufacturing process. Please note that
studies for reproductive toxicology if you include your name, contact
Dated: September 12, 2017. assessment may not be needed (e.g., for information, or other information that
Seema Verma, pharmaceuticals intended for use in identifies you in the body of your
Administrator, Centers for Medicare & postmenopausal women only). The comments, that information will be
Medicaid Services. intended outcome of this guidance is to posted on https://www.regulations.gov/.
[FR Doc. 2017–20883 Filed 9–28–17; 8:45 am] provide for more consistent labeling for • If you want to submit a comment
BILLING CODE 4120–01–P oncology pharmaceuticals and to reduce with confidential information that you
the conduct of nonclinical studies that do not wish to be made available to the
are not informative on product use. public, submit the comment as a
DEPARTMENT OF HEALTH AND DATES: Although you can comment on written/paper submission and in the
HUMAN SERVICES any guidance at any time (see 21 CFR manner detailed (see ‘‘Written/Paper
10.115(g)(5)), to ensure that the Agency Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
considers your comment on this draft Written/Paper Submissions
[Docket No. FDA–2017–D–2165] guidance before it begins work on the
Submit written/paper submissions as
final version of the guidance, submit
Oncology Pharmaceuticals: follows:
either electronic or written comments • Mail/Hand delivery/Courier (for
Reproductive Toxicity Testing and on the draft guidance by November 28,
Labeling Recommendations; Draft written/paper submissions): Division of
2017. Dockets Management (HFA–305), Food
Guidance for Industry; Availability
ADDRESSES: You may submit comments and Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, as follows: Lane, Rm. 1061, Rockville, MD 20852.
HHS.
Electronic Submissions • For written/paper comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ACTION: Notice of availability. submitted to the Division of Dockets
Submit electronic comments in the Management, FDA will post your
SUMMARY: The Food and Drug following way: comment, as well as any attachments,
Administration (FDA or Agency) is • Federal eRulemaking Portal: except for information submitted,
announcing the availability of a draft https://www.regulations.gov/. Follow marked and identified, as confidential,
guidance for industry entitled the instructions for submitting if submitted as detailed in
‘‘Oncology Pharmaceuticals: comments. Comments submitted ‘‘Instructions.’’
Reproductive Toxicity Testing and electronically, including attachments, to Instructions: All submissions received
Labeling Recommendations.’’ The https://www.regulations.gov/ will be must include the Docket No. FDA–
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![45594 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
2017–D–2165 for ‘‘Oncology your requests. See the SUPPLEMENTARY labeling recommendations for oncology
Pharmaceuticals: Reproductive Toxicity INFORMATION section for electronic pharmaceuticals. It does not establish
Testing and Labeling Recommendations; access to the draft guidance document. any rights for any person and is not
Draft Guidance for Industry; FOR FURTHER INFORMATION CONTACT: John binding on FDA or the public. You can
Availability.’’ Received comments will Leighton, Center for Drug Evaluation use an alternative approach if it satisfies
be placed in the docket and, except for and Research, Food and Drug the requirements of the applicable
those submitted as ‘‘Confidential Administration, 10903 New Hampshire statutes and regulations. This is not a
Submissions,’’ publicly viewable at Ave., Bldg. 22, Rm. 2204, Silver Spring, significant regulatory action subject to
https://www.regulations.gov/ or at the MD 20993–0002, 301–796–0750; or Executive Order 12866.
Division of Dockets Management Haleh Saber, Center for Drug Evaluation
between 9 a.m. and 4 p.m., Monday II. The Paperwork Reduction Act of
and Research, Food and Drug 1995
through Friday. Administration, 10903 New Hampshire
• Confidential Submissions—To Ave., Bldg. 22, Rm. 2117, Silver Spring, This guidance refers to previously
submit a comment with confidential MD 20993–0002, 301–796–0750. approved collections of information that
information that you do not wish to be are subject to review by the Office of
SUPPLEMENTARY INFORMATION:
made publicly available, submit your Management and Budget (OMB) under
comments only as a written/paper I. Background the Paperwork Reduction Act of 1995
submission. You should submit two (44 U.S.C. 3501–3520). The collections
FDA is announcing the availability of
copies total. One copy will include the of information in 21 CFR parts 312 and
a draft guidance for industry entitled
information you claim to be confidential 314 have been approved under OMB
‘‘Oncology Pharmaceuticals:
with a heading or cover note that states control numbers 0910–0014 and 0910–
Reproductive Toxicity Testing and
‘‘THIS DOCUMENT CONTAINS 0001, respectively. The collections of
Labeling Recommendations.’’ This
CONFIDENTIAL INFORMATION.’’ The information in 21 CFR 201.56, 201.57,
guidance presents FDA’s current
Agency will review this copy, including and the final rule ‘‘Content and Format
approach to assessing potential risks to
the claimed confidential information, in of Labeling for Human Prescription
its consideration of comments. The embryo-fetal development associated
with oncology pharmaceutical use in Drug and Biological Products;
second copy, which will have the Requirements for Pregnancy and
claimed confidential information male and female patients. The term
pharmaceutical in this guidance refers Lactation Labeling’’ have been approved
redacted/blacked out, will be available under OMB control numbers 0910–0572
for public viewing and posted on to small molecules, therapeutic
proteins, antibodies, and related and 0910–0624.
https://www.regulations.gov/. Submit
both copies to the Division of Dockets products such as conjugated products. III. Electronic Access
Management. If you do not wish your The guidance describes when embryo- Persons with access to the Internet
name and contact information to be fetal developmental studies for oncology may obtain the draft guidance at either
made publicly available, you can pharmaceuticals may be warranted for https://www.fda.gov/Drugs/Guidance
provide this information on the cover different types of pharmaceuticals, such ComplianceRegulatoryInformation/
sheet and not in the body of your as cytotoxic, biological, and conjugated Guidances/default.htm or https://
comments and you must identify this pharmaceuticals, or pharmaceuticals www.regulations.gov/.
information as ‘‘confidential.’’ Any used in combinations. The guidance
also discusses other aspects of a Dated: September 22, 2017.
information marked as ‘‘confidential’’ Anna K. Abram,
will not be disclosed except in nonclinical reproductive toxicity
evaluation, such as fertility and pre- and Deputy Commissioner for Policy, Planning,
accordance with 21 CFR 10.20 and other Legislation, and Analysis.
applicable disclosure law. For more postnatal evaluation. The guidance
addresses the need for a reproductive [FR Doc. 2017–20906 Filed 9–28–17; 8:45 am]
information about FDA’s posting of
comments to public dockets, see 80 FR toxicity evaluation when BILLING CODE 4164–01–P
56469, September 18, 2015, or access pharmaceuticals are used in specific
the information at: https://www.gpo.gov/ populations (e.g., pediatric, males-only,
or postmenopausal women). DEPARTMENT OF HEALTH AND
fdsys/pkg/FR-2015-09-18/pdf/2015-
Although current regulatory HUMAN SERVICES
23389.pdf.
Docket: For access to the docket to guidances exist regarding the need to
Food and Drug Administration
read background documents or the assess the embryo-fetal developmental
electronic and written/paper comments toxicity potential of pharmaceuticals [Docket No. FDA–2015–D–4644]
received, go to https:// and the overall design of the studies,
www.regulations.gov/ and insert the this guidance provides additional Advancement of Emerging Technology
docket number, found in brackets in the recommendations on specific types of Applications for Pharmaceutical
heading of this document, into the products and for specific populations, Innovation and Modernization;
‘‘Search’’ box and follow the prompts which are not covered under other Guidance for Industry; Availability
and/or go to the Division of Dockets guidances. In addition, this guidance AGENCY: Food and Drug Administration,
Management, 5630 Fishers Lane, Rm. provides recommendations on the use of HHS.
1061, Rockville, MD 20852. contraception and the duration of its use ACTION: Notice of availability.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Submit written requests for single to minimize the potential risks
copies of the draft guidance to the associated with the use of oncology SUMMARY: The Food and Drug
Division of Drug Information, Center for pharmaceuticals. Administration (FDA or Agency) is
Drug Evaluation and Research, Food This draft guidance is being issued announcing the availability of a
and Drug Administration, 10001 New consistent with FDA’s good guidance guidance for industry entitled
Hampshire Ave., Hillandale Building, practices regulation (21 CFR 10.115). ‘‘Advancement of Emerging Technology
4th Floor, Silver Spring, MD 20993– The draft guidance, when finalized, will Applications for Pharmaceutical
0002. Send one self-addressed adhesive represent the current thinking of FDA Innovation and Modernization.’’ This
label to assist that office in processing on reproductive toxicity testing and guidance finalizes the draft guidance
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45781/page/2.svg)
Document Created: 2017-09-29 03:26:46
Document Modified: 2017-09-29 03:26:46
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 28, 2017. | |
| Contact | 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- 796-0750; or 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, 301-796-0750. | |
| FR Citation | 82 FR 45593 |
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