[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Page 76889]
[FR Doc No: 2023-24609]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No.: PHMSA-2023-0113; Notice No. 2023-14]

Hazardous Materials: Public Meeting Notice for the Office of
Hazardous Materials Safety Research, Development & Technology Virtual
Forum

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation.

ACTION: Notice of public meeting.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration's
(PHMSA) Office of Hazardous Materials Safety (OHMS) will hold a public
Research, Development & Technology Virtual Forum on Zoom Webinar on
November 28, 2023. During this one-day event, OHMS will present the
results of recently completed projects; brief attendees on new project
plans; and obtain stakeholder input on the direction of current and
future research topics, including mitigation of climate change, risk
management and mitigation, packaging integrity, emerging technology,
and technical analysis to aid risk assessment. The forum will enable
OHMS to solicit comments related to new research topics that may be
considered for inclusion in its future work. OHMS is particularly
interested in the research gaps associated with energetic materials
(explosives) characterization and transportation; safe transportation
of energy products (e.g., crude oil); safe containment and
transportation of compressed gases; and safe packaging and
transportation of charge storage devices (e.g., lithium- ion batteries)
and how these might aid in mitigation of climate change. The forum will
also provide opportunities for stakeholder input to identify other
research gaps related to the transportation of hazardous materials.

ADDRESSES: The meeting will be held virtually on Zoom Meeting on
November 28, 2023, from 09:00 a.m. to 5:00 p.m. EST.
    Registration: DOT requests attendees pre-register for this meeting
by completing the form at https://usdot.zoomgov.com/webinar/register/WN_pCY0ntXkQbejLrbZFcScow. In addition to Zoom Meeting, conference
call-in and ``live meeting'' capability will also be provided.
Conference call-in and live meeting access information will be provided
in the registration confirmation email.

FOR FURTHER INFORMATION CONTACT: Andy Leyder by mail at the Office of
Hazardous Materials Safety, Research, Development & Technology,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, 1200 New Jersey Avenue SE, West Building: Room W12-
140, Washington, DC 20590-0001; by phone at<PHONE_NUMBER>; or by email
at [email protected].

    Issued in Washington, DC, on November 2, 2023.
William Quade,
Deputy Associate Administrator for Hazardous Materials Safety Pipeline
and Hazardous Materials Safety Administration.
[FR Doc. 2023-24609 Filed 11-6-23; 8:45 am]
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[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67037-67039]
[FR Doc No: 2022-24113]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1469]

M10 Bioanalytical Method Validation and Study Sample Analysis;
International Council for Harmonisation; 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 ``M10
Bioanalytical Method Validation and Study Sample Analysis.'' The
guidance was prepared under the auspices of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH), formerly the International Conference on
Harmonisation. The guidance describes recommendations for method
validation for bioanalytical assays for nonclinical and clinical
studies that generate data to support regulatory submissions, including
the procedures and processes that should be characterized for
chromatographic and ligand-binding assays that are used to measure the
parent and active metabolites of drugs administered in nonclinical and
clinical subjects. The guidance is intended to provide industry with
harmonized regulatory expectations for bioanalytical method validation
of assays used to support regulatory submissions. The guidance replaces
the draft guidance ``M10 Bioanalytical Method Validation'' issued on
June 27, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on November 7, 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-1469 for ``M10 Bioanalytical Method Validation and Study
Sample Analysis.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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 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<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Brian Booth,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 2186, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``M10 Bioanalytical Method Validation and Study Sample
Analysis.'' The guidance was prepared under the auspices of ICH. ICH
has the mission of achieving greater regulatory harmonization worldwide
to ensure that safe, effective, high-quality medicines are developed,
registered, and maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of June 27, 2019 (84 FR 30732), FDA
published a notice announcing the availability of a draft guidance
entitled ``M10 Bioanalytical Method Validation.'' The notice gave
interested persons an opportunity to submit comments by September 25,
2019.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies on May 24, 2022.
    This guidance provides recommendations on the validation of
bioanalytical assays that support regulatory submissions. The final
guidance describes the various elements of and recommendations for
method validation for assays in nonclinical and clinical studies of new
drugs and generic drugs and applies to chromatographic and ligand-
binding assays for parent drug and active metabolites in biological
matrices such as plasma, blood, or serum. This guidance finalizes the
draft guidance of the same title issued in June 2019.
    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 ``M10 Bioanalytical Method Validation and
Study Sample Analysis.'' 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 does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (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 for investigational new drug applications have been
approved under OMB control number 0910-0014. The collections of
information for review of new drug applications and abbreviated new
drug applications have been approved under OMB control number 0910-
0001. The collections of information for review of biologics

license applications have been approved under OMB control number 0910-
0338. The collections of information pertaining to Good Laboratory
Practice Regulations have been approved under OMB control number 0910-
0119. The collections of information pertaining to Good Clinical
Practice have been approved under OMB control number 0910-0843.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24113 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P