[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10122-10123]
[FR Doc No: 2021-03285]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4399-DR; Docket ID FEMA-2021-0001]

Florida; Amendment No. 14 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4399-DR), dated October 11, 2018, and
related determinations.

DATES: This change occurred on January 15, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Kevin A.
Wallace, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Jeffrey L. Coleman as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03285 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Notices]
[Pages 26435-26436]
[FR Doc No: 2014-10578]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0052]

Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications.'' The draft guidance, when finalized, will
explain our current thinking on the preparation of regulatory
submissions for obtaining exemptions for ingredients from the labeling
requirements for major food allergens in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) through submission of either a petition or
a notification.

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 we begin work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 5, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition (HFS-200), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed
adhesive labels to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Steven Gendel, Center for Food and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance entitled,
``Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications.'' This draft guidance is intended to help
industry prepare petitions and notifications seeking exemptions from
the labeling requirements for ingredients derived from major food
allergens. The Food Allergen Labeling and Consumer Protection Act of
2004 (FALCPA) (Title II, Pub. L. 108-282) amended the FD&C Act by
defining the term ``major food allergen'' and stating that foods
regulated under the FD&C Act are misbranded unless they declare the
presence of each major food allergen on the product label using the
common or usual name of that major food allergen.
    Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) now defines a
major food allergen as ``[m]ilk, egg, fish (e.g., bass, flounder, or
cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts
(e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans'' and
also as a food ingredient that contains protein derived from such
foods. The definition excludes any highly refined oil derived from a
major food allergen and any ingredient derived from such highly refined
oil.
    In some cases, the production of an ingredient derived from a major
food allergen may alter or eliminate the allergenic proteins in that
derived ingredient to such an extent that it does not contain
allergenic protein. In addition, a major food allergen may be used as
an ingredient or as a component of an ingredient such that the level of
allergenic protein in finished food products does not cause an allergic
response that poses a risk to human health. Therefore, FALCPA provides
two mechanisms through which such ingredients may become exempt from
the labeling requirement of section 403(w)(1) of the FD&C Act (21
U.S.C. 343(w)(1)). An ingredient may obtain an exemption through
submission and approval of a petition containing scientific evidence
that demonstrates that the ingredient ``does not cause an allergic
response that poses a risk to human health'' (section 403(w)(6) of the
FD&C Act). Alternately, an ingredient may become exempt through
submission of a notification containing scientific evidence showing
that the ingredient ``does not contain allergenic protein'' or that
there has been a previous determination through a premarket approval
process under section 409 of the FD&C Act (21 U.S.C. 348) that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(7) of the FD&C Act).
    This draft guidance is being issued consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish
notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, we will publish a
60-day notice on the proposed collection of information in a future
issue of the Federal Register.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.
    Dated: May 2, 2014.

Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10578 Filed 5-7-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10353-10354]
[FR Doc No: 2023-03372]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4002]

Electronic Submission of Adverse Event Reports to the Food and
Drug Administration Adverse Event Reporting System Using International
Council of Harmonisation E2B(R3) Standards; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a series of two public meetings entitled ``Electronic
Submission of Adverse Event Reports to FDA Adverse Event Reporting
System (FAERS) Using International Council for Harmonisation (ICH)
E2B(R3) Standards.'' The purpose of these public meetings is to provide
the pharmaceutical industry and other interested parties with updated
information on the plans, progress, and technical specifications to
upgrade electronic submission standards for drug, biological product,
and drug- or biologic-led combination products in the premarket and
postmarket safety surveillance programs managed by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER). These meetings are part of a public meeting series
initiated by FDA in 2019 to communicate FDA's implementation plan and
regional requirements for ICH E2B(R3). The 2023 meetings will focus on
enhancements to electronic submission of Individual Case Safety Reports
(ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from
stakeholders as it fulfills its commitment to implement ICH E2B(R3) and
will use the information provided by the public to inform the
enhancements to FAERS required for the implementation of ICH E2B(R3)
standards and relevant regional variations.

DATES: The first public meeting will be held on April 4, 2023, from 9
a.m. to 3 p.m. The second public meeting will be held on November 7,
2023, from 9 a.m. to 12 p.m. Submit either electronic or written
comments on these public meetings by May 3, 2023, for the first public
meeting, and by December 6, 2023, for the second public meeting. See
the SUPPLEMENTARY INFORMATION section for registration dates and
information.

ADDRESSES: The public meeting will be held virtually, by webcast only.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. For timely consideration, we
request that electronic comments be submitted no later than 30 days
after each public meeting (i.e., comments submitted by or before May 3,
2023, for the first public meeting; and December 6, 2023, for the
second public meeting. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of December 6, 2023). Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

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-N-4002 for ``Electronic Submission of Adverse Event Reports to
FAERS using ICH E2B(R3) Standards.'' Received comments, those filed in
a timely manner (see ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Suranjan De, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993-0002, 240-
402-0498, [email protected]; or Katie Rivers, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7336, Silver Spring, MD 20993-0002, 301-
796-1818, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to achieving the long-term goal of improving the
predictability and consistency of the electronic submission process and
enhancing transparency and accountability of FDA information
technology-related activities. FDA participated in the development of
an ICH E2B guideline \1\ pertaining to the submission of adverse event
reports to the FAERS system: ``Implementation Guide for Electronic
Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data
Elements and Message Specification.'' In the Prescription Drug User Fee
Act VI commitment letter, FDA committed to the goal of allowing
industry to participate in user acceptance testing and/or organizing a
meeting to provide industry an opportunity to provide feedback in
advance of the Agency's implementation of ICH E2B(R3) data standards
for electronic submission of adverse event reports. The commitment
letter outlines FDA's performance goals and procedures under the
Prescription Drug User Fee Act VI program for the years 2018-2022
(available at https://www.fda.gov/media/99140/download). In 2019 and
2020 FDA had conducted a series of three public meetings to communicate
FDA's implementation plan and regional requirements for ICH E2B(R3).
FDA incorporated the recommendations received in the comments from the
2019 and 2020 public meetings as ICH E2B(R3) regional technical
specifications.
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    \1\ The ICH E2B(R3) IG guideline (http://estri.ich.org/e2br3/index.htm) provides technical and business specifications for the
harmonized, core set of ICH data elements.
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II. Topics for Discussion at the Public Meeting

    The public meetings will include a general discussion of the
updated specifications for premarketing and postmarketing ICSRs listed
in the FDA Regional Implementation Guide for E2B(R3) Electronic
Submission of Individual Case Safety Reports for Drug and Biological
Products that published in April 2022 (available at https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions). The goal of this discussion is to communicate the updated
specific regional requirements that will enhance the quality of adverse
event reports received by the Agency. The information exchange at the
meetings will enhance the pharmaceutical industry's knowledge of the
processes needed to implement ICH E2B(R3) into their systems. In
addition, the comments provided by participating stakeholders will
continue to inform CDER and CBER's plans for the implementation of ICH
E2B(R3) for drugs, biological products, and drug- or biologic-led
combination products.
    During the public meetings, FDA intends to discuss: (1) E2B(R3)
Regional (U.S.) data elements and business rules; (2) usage of data
standards in E2B(R3); (3) submission paths for premarket and postmarket
ICSRs; (4) forward compatible rules; (5) review of FDA Regional
Implementation Specifications for ICH E2B(R3) Implementation; and (6)
FDA ICSR XML Instances. One or more topics may be discussed in each
meeting. FDA will consider all comments made at these public meetings
or received through the docket (see ADDRESSES).

III. Participating in the Public Meeting

    Registration: To register for the public meetings, please visit
https://fdae2br3.eventbrite.com by March 31, 2023, for the first
meeting and November 3, 2023, for the second meeting. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    An agenda will be made available at least 3 days before each public
meeting at https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using.
    Streaming Webcast of the Public Meetings and Video of the Public
Meetings: These public meetings will only be webcast; the URL will be
posted at https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using at least 1 day before each meeting. A recording of the
public workshops will be available at the same website address for 1
year.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using.

    Dated: February 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03372 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Page 26976]
[FR Doc No: 2010-11433]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3311-EM; Docket ID FEMA-2010-0002]

Rhode Island; Amendment No. 3 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Rhode Island (FEMA-3311-EM), dated March 30, 2010, and
related determinations.

DATES: Effective Date: May 5, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Craig A.
Gilbert, of FEMA is appointed to act as the Federal Coordinating
Officer for this emergency.
    This action terminates the appointment of Gracia B. Szczech as
Federal Coordinating Officer for this emergency.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-11433 Filed 5-12-10; 8:45 am]
BILLING CODE 9111-23-P