82 FR 52306 - S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals; International Council for Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 217 (November 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 217 (November 13, 2017)
| Page Range | 52306-52308 | |
| FR Document | 2017-24483 |
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)] [Notices] [Pages 52306-52308] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24483] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5138] S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance replaces the existing guidance entitled ``S5(R2) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The draft guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays. [[Page 52307]] 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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 12, 2018. 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): 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 Office, 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-2017-D-5138 for ``S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' 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 Office 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 Office. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), 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 (CBER), 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. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6474, Silver Spring, MD 20993-0002, 301-796-0174; or Martin (Dave) Green, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3270, Silver Spring, MD 20993-0002, 301-796-2640. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301- 796-4548. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' In recent years, regulatory authorities and industry associations have participated in many important initiatives to promote international harmonization of regulatory requirements. FDA has participated in several meetings designed to enhance harmonization and is committed to seeking scientifically based, harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and [[Page 52308]] Swissmedic. Any party eligible to become a member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. In August 2017, the ICH Assembly endorsed the draft guidance titled ``S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals'' and agreed that the guidance should be made available for public comment. The draft guidance is the product of the S5(R3) Safety Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the S5(R3) Safety Expert Working Group. The draft guidance replaces the existing guidance entitled ``S5(R2) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The guidance has undergone major revisions to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays. To support using alternative assays, compounds that are either positive or negative in their ability to induce embryolethality or malformations are used in the process of qualifying the assays. Although a number of compounds have been identified in the draft guidance's Annex, section 11.3.4, Tables 9-6 and 9-7, with the type of information for the compounds, the list is not complete; therefore, FDA is requesting data in the form of public comments to the docket for additional positive and negative reference compounds for potential inclusion into the list. These compounds can be either pharmaceuticals or non-pharmaceuticals and should be commercially available. For additional guidance, please refer to Endnote 3 in the S5(R3) guidance. This is not a request for data for the compounds already listed in Table 9-6, nor is this a request for examples of assays that could be used. 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 ``S5(R3) Detection of Toxicity to Reproduction for Human 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 guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24483 Filed 11-9-17; 8:45 am] BILLING CODE 4164-01-P
![52306 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
SUPPLEMENTARY INFORMATION: Under the on respondents, including through the information about the number and types
PRA (44 U.S.C. 3501–3520), federal use of automated collection techniques of individuals who receive TBI-related
agencies must obtain approval from the when appropriate and other forms of home and community based services.
Office of Management and Budget information technology. Finally, ACL seeks information
(OMB) for each collection of regarding the involvement of people
Purpose
information they conduct or sponsor. with TBI in advisory and program
‘‘Collection of information’’ is defined The purpose of the Traumatic Brain support roles.
in 44 U.S.C. 3502(3) and 5 CFR Injury (TBI) State Partnership program The data collected will allow ACL to
1320.3(c) and includes agency requests is to increase access to rehabilitation determine the extent to which the grant
or requirements that members of the and other services for individuals with program is meeting its goals of
public submit reports, keep records, or traumatic brain injury. Under the expanding and improving services,
provide information to a third party. Traumatic Brain Injury Reauthorization generating sustainable funding streams,
Section 3506(c)(2)(A) of the PRA (44 Act of 2014 (Pub. L. 113–196), the and enriching service systems to better
U.S.C. 3506(c)(2)(A)) requires federal Traumatic Brain Injury State serve individuals with TBI and their
agencies to provide a 60-day notice in Partnership program transitioned from families. The data will also help ACL
the Federal Register concerning each the Health Resources and Services develop and expand baseline
proposed collection of information Administration (HRSA) to the information around the nature and
before submitting the collection to OMB Administration for Community Living scope of the incidence of TBI.
for approval. (ACL). Under this law, the Secretary, Additionally, this data collection will
To comply with the above acting through ACL, was authorized to help ACL illustrate the return on
requirement, ACL is publishing a notice ‘‘make grants to States and American investment of the TBI funds in terms of
of a new collection of information as set Indian consortia for the purpose of system change (i.e., changes in policies
forth in this document. With respect to carrying out projects to improve access and practices and the development of
the following collection of information, to rehabilitation and other services networks). By matching the project
ACL invites comments on: (1) Whether regarding traumatic brain injury.’’ ACL dollars spent against measurable
the proposed collection of information seeks to collect performance measure improvements in state systems for
is necessary for the proper performance data from state grantees consistent with delivering services and supports to
of ACL’s functions, including whether the TBI State Partnership program’s people living with TBI, ACL will have
the information will have practical purpose and ACL’s mission to a strong indicator of the effect of the TBI
utility and/or help ACL illustrate the ‘‘Maximize the independence, well- program on the quality of services
program’s return on investment; (2) the being, and health of older adults, people which ultimately impact the lives of
accuracy of ACL’s estimate of the with disabilities across the lifespan, and people across the country living with
burden of the proposed collection of their families and caregivers.’’ TBI. The proposed data collection forms
information, including the validity of ACL seeks data on a semi-annual may be found on the ACL Web site for
the methodology and assumptions used; basis on the types of practices, review at: https://www.acl.gov/about-
(3) ways to enhance the quality, utility, protocols, and activities performed by acl/public-input.
and clarity of the information to be each grantee, as well as the cost of each Estimated Program Burden: The
collected; and (4) ways to minimize the activity and the number and types of annual reporting burden estimates are
burden of the collection of information people they served. ACL also seeks shown below.
Average
Number of
Number of burden per Total
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)
States ............................ State Performance Report ................................... * 45 2 16 1,440
* This is the highest number of awards anticipated, but it is possible that there will be less. If less than 45 grants are awarded, the total burden
hours will be adjusted proportionally.
Dated: November 7, 2017. DEPARTMENT OF HEALTH AND guidance entitled ‘‘S5(R3) Detection of
Mary Lazare, HUMAN SERVICES Toxicity to Reproduction for Human
Principal Deputy Administrator. Pharmaceuticals.’’ The draft guidance
Food and Drug Administration was prepared under the auspices of the
[FR Doc. 2017–24525 Filed 11–9–17; 8:45 am]
International Council for Harmonisation
BILLING CODE 4154–01–P [Docket No. FDA–2017–D–5138] (ICH), formerly the International
Conference on Harmonisation. The draft
S5(R3) Detection of Toxicity to guidance replaces the existing guidance
Reproduction for Human entitled ‘‘S5(R2) Detection of Toxicity to
Pharmaceuticals; International Council
Reproduction for Human
for Harmonisation; Draft Guidance for
Pharmaceuticals.’’ The draft guidance is
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Industry; Availability
intended to align with other ICH
AGENCY: Food and Drug Administration, guidances, elaborate on concepts to
HHS. consider when designing studies, and
ACTION: Notice of availability. identify potential circumstances in
which a risk assessment can be made
SUMMARY: The Food and Drug based on preliminary studies. It also
Administration (FDA or Agency) is clarifies the qualification and potential
announcing the availability of a draft use of alternative assays.
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![52308 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
Swissmedic. Any party eligible to on ‘‘S5(R3) Detection of Toxicity to Officer, 14N39, 5600 Fishers Lane,
become a member in accordance with Reproduction for Human Rockville, MD 20857.
the ICH Articles of Association can Pharmaceuticals.’’ It does not establish FOR FURTHER INFORMATION CONTACT: To
apply for membership in writing to the any rights for any person and is not request more information on the
ICH Secretariat. The ICH Secretariat, binding on FDA or the public. You can proposed project or to obtain a copy of
which coordinates the preparation of use an alternative approach if it satisfies the data collection plans and draft
documentation, operates as an the requirements of the applicable instruments, email paperwork@hrsa.gov
international nonprofit organization and statutes and regulations. This guidance or call Lisa Wright-Solomon, the HRSA
is funded by the members of the ICH is not subject to Executive Order 12866. Information Collection Clearance Officer
Association. at (301) 443–1984.
The ICH Assembly is the overarching II. Electronic Access
SUPPLEMENTARY INFORMATION: When
body of the Association and includes Persons with access to the internet submitting comments or requesting
representatives from each of the ICH may obtain the draft guidance at https:// information, please include the
members and observers. www.regulations.gov, https://
In August 2017, the ICH Assembly information request collection title for
www.fda.gov/Drugs/ reference, in compliance with Section
endorsed the draft guidance titled GuidanceCompliance
‘‘S5(R3) Detection of Toxicity to 3506(c)(2)(A) of the Paperwork
RegulatoryInformation/Guidances/ Reduction Act of 1995.
Reproduction for Human default.htm, or https://www.fda.gov/
Pharmaceuticals’’ and agreed that the Information Collection Request Title:
BiologicsBloodVaccines/ Voluntary Partner Surveys to Implement
guidance should be made available for GuidanceCompliance
public comment. The draft guidance is Executive Order 12862 in the Health
RegulatoryInformation/Guidances/ Resources and Services Administration
the product of the S5(R3) Safety Expert default.htm.
Working Group of the ICH. Comments OMB No. 0915–0212—Extension.
about this draft will be considered by Dated: November 2, 2017. Abstract: In response to Executive
FDA and the S5(R3) Safety Expert Anna K. Abram, Order 12862, HRSA is proposing to
Working Group. Deputy Commissioner for Policy, Planning, conduct voluntary customer surveys of
The draft guidance replaces the Legislation, and Analysis. its partners to assess strengths and
existing guidance entitled ‘‘S5(R2) [FR Doc. 2017–24483 Filed 11–9–17; 8:45 am] weaknesses in program services and
Detection of Toxicity to Reproduction BILLING CODE 4164–01–P processes. HRSA partners are typically
for Human Pharmaceuticals.’’ The state or local governments, health care
guidance has undergone major revisions facilities, health care consortia, health
to align with other ICH guidances, DEPARTMENT OF HEALTH AND care providers, and researchers. HRSA
elaborate on concepts to consider when HUMAN SERVICES is requesting continued approval for a
designing studies, and identify potential generic clearance from OMB to conduct
circumstances in which a risk Health Resources and Services the partner surveys.
assessment can be made based on Administration Partner surveys to be conducted by
preliminary studies. It also clarifies the HRSA might include, for example, mail
qualification and potential use of Agency Information Collection or telephone surveys of grantees to
alternative assays. Activities: Proposed Collection: Public determine satisfaction with grant
To support using alternative assays, Comment Request; Information processes or technical assistance
compounds that are either positive or Collection Request Title: Voluntary provided by a contractor, or in-class
negative in their ability to induce Partner Surveys To Implement evaluation forms completed by
embryolethality or malformations are Executive Order 12862 in the Health providers who receive training from
used in the process of qualifying the Resources and Services HRSA grantees to measure satisfaction
assays. Although a number of Administration, OMB No. 0915–0212— with the training experience. HRSA will
compounds have been identified in the Extension use the results of these surveys to plan
draft guidance’s Annex, section 11.3.4, AGENCY: Health Resources and Services and redirect resources and efforts as
Tables 9–6 and 9–7, with the type of Administration (HRSA), Department of needed to improve services and
information for the compounds, the list Health and Human Services. processes.
is not complete; therefore, FDA is HRSA may also use focus groups to
requesting data in the form of public ACTION: Notice. gain partner input into the design of
comments to the docket for additional mail and telephone surveys. Focus
SUMMARY: In compliance with the
positive and negative reference groups, in-class evaluation forms, mail
requirement for opportunity for public
compounds for potential inclusion into surveys, and telephone surveys are
comment on proposed data collection
the list. These compounds can be either expected to be the preferred data
projects of the Paperwork Reduction Act
pharmaceuticals or non- collection methods.
of 1995, HRSA announces plans to
pharmaceuticals and should be A generic approval allows HRSA to
submit an Information Collection
commercially available. For additional conduct a limited number of partner
Request (ICR), described below, to the
guidance, please refer to Endnote 3 in surveys without a full-scale OMB
Office of Management and Budget
the S5(R3) guidance. This is not a review of each survey. If this request
(OMB). Prior to submitting the ICR to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
request for data for the compounds receives continued approval,
OMB, HRSA seeks comments from the
already listed in Table 9–6, nor is this information on each individual partner
public regarding the burden estimate,
a request for examples of assays that survey will not be published in the
below, or any other aspect of the ICR.
could be used. Federal Register.
This draft guidance is being issued DATES: Comments on this ICR must be Burden Statement: Burden in this
consistent with FDA’s good guidance received no later than January 12, 2018. context means the time expended by
practices regulation (21 CFR 10.115). ADDRESSES: Submit your comments to persons to generate, maintain, retain,
The draft guidance, when finalized, will paperwork@hrsa.gov or mail the HRSA disclose or provide the information
represent the current thinking of FDA Information Collection Clearance requested. This includes the time
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Document Created: 2017-11-10 01:18:10
Document Modified: 2017-11-10 01:18:10
| 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 February 12, 2018. | |
| Contact | Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6474, Silver Spring, MD 20993-0002, 301-796-0174; or Martin (Dave) Green, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3270, Silver Spring, MD 20993-0002, 301-796-2640. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301- 796-4548. | |
| FR Citation | 82 FR 52306 |
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