[Federal Register Volume 85, Number 25 (Thursday, February 6, 2020)]
[Notices]
[Pages 6957-6959]
[FR Doc No: 2020-02373]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3324]

Use of Serological Tests To Reduce the Risk of Transfusion-
Transmitted Human T-Lymphotropic Virus Types I and II; 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 entitled ``Use of Serological
Tests to Reduce the Risk of Transfusion-Transmitted Human T-
Lymphotropic Virus Types I and II (HTLV-I/II).'' The guidance document
provides blood collection establishments with recommendations regarding
the use of

serological tests to reduce the risk of HTLV-I/II transmission by blood
and blood components. The guidance announced in this notice finalizes
the draft guidance entitled ``Recommendations for Requalification of
Blood Donors Deferred Because of Reactive Test Results for Antibodies
to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)'' dated
September 2018. The guidance also consolidates FDA's other previously
issued recommendations on HTLV-I/II into one document. Therefore, the
guidance also supersedes the recommendations specific to HTLV-1
contained in the memorandum to blood establishments entitled
``Recommendations for the Quarantine and Disposition of Units from
Prior Collections from Donors with Repeatedly Reactive Screening Tests
for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-
Lymphotropic Virus Type I (HTLV-I)'' dated July 1996. In addition, the
guidance supersedes the memorandum to blood establishments entitled
``HTLV-I Antibody Testing, Memorandum'' dated November 1988; the
memorandum to blood establishments entitled ``HTLV-I Antibody Testing,
Memorandum'' dated July 1989; and the document entitled ``Guidance for
Industry: Donor Screening for Antibodies to HTLV-II'' dated August
1997.

DATES: The announcement of the guidance is published in the Federal
Register on February 6, 2020.

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-2018-D-3324 for ``Use of Serological Tests to Reduce the Risk of
Transfusion Transmitted Human T-Lymphotropic Virus Types I and II
(HTLV-I/II).'' 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 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.
    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 guidance to 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 the 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: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Use of
Serological Tests to Reduce the Risk of Transfusion-Transmitted Human
T-Lymphotropic Virus Types I and II (HTLV-I/II).'' The guidance
document provides blood collection establishments with recommendations
regarding the use of serological tests to reduce the risk of HTLV-I/II
transmission by blood and blood components.
    In the Federal Register of September 25, 2018 (83 FR 48448), FDA
announced the availability of the draft guidance entitled
``Recommendations for Requalification of Blood Donors Deferred Because
of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus
Types I and II (anti-HTLV-I/II)'' dated September 2018. FDA received a
few comments on the draft guidance and those comments

were considered as the guidance was finalized.
    The guidance announced in this notice finalizes the draft guidance
entitled ``Recommendations for Requalification of Blood Donors Deferred
Because of Reactive Test Results for Antibodies to Human T-Lymphotropic
Virus Types I and II (anti-HTLV-I/II)'' dated September 2018. The
guidance also consolidates FDA's other previously issued
recommendations on HTLV-I/II into one document. Therefore, the guidance
also supersedes the recommendations specific to HTLV-1 contained in the
memorandum to blood establishments, entitled ``Recommendations for the
Quarantine and Disposition of Units from Prior Collections from Donors
with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-
I)'' dated July 1996. In addition, the guidance supersedes the
memorandum to blood establishments entitled ``HTLV-I Antibody Testing,
Memorandum'' dated November 1988; the memorandum to blood
establishments entitled ``HTLV-I Antibody Testing, Memorandum'' dated
July 1989; and the document entitled ``Guidance for Industry: Donor
Screening for Antibodies to HTLV-II'' dated August 1997.
    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 the use of serological tests to reduce the
risk of transfusion-transmitted human T-lymphotropic virus types I and
II. 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

    This 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. 3501-3521). The
collections of information in 21 CFR part 601 and Form FDA 356h have
been approved under OMB control number 0910-0338, and the collections
of information in 21 CFR parts 610 and 606 have been approved under OMB
control number 0910-0116.

III. Electronic Access

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

    Dated: February 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02373 Filed 2-5-20; 8:45 am]
 BILLING CODE 4164-01-P


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43737602
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43709033
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45614707
Khalil, S. (2002) Prenatal Developmental Toxicity Study in the Rat: CGA-263208
Technical: Final Report: Lab Project Number: 20013025: 2693-01. Unpublished study
prepared by RCC Ltd. 474 p. {OPPTS 870.3700}
83-4       2-generation repro.-rat
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Khalil, S. (1993) CGA-219417 Technical: Two-Generation Reproduction Study in Rats:
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Amended (Final Report): Lab Project Number: 891328. Unpublished study prepared by
Ciba-Geigy Ltd. 1409 p.
83-5       Dietary: Combined Chronic Toxicity/Oncogenicity Studies
MRID
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Chow, E. (1997) Cyprodinil Technical: 24-Months Carcinogenicity and Chronic Toxicity
Study in Rats: Supplement: Lab Project Number: CGA 219417: 891326. Unpublished
study prepared by Novartis Crop Protection, Inc. 86 p.
84-2       Interaction with Gonadal DNA
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43709035
Geleick, D. (1991) CGA-219417 Technical: Authoradiographic (sic) DNA Repair Test on
Rat Hepatocytes in vitro: Amended: Lab Project Number: 901083. Unpublished study
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43709036
Geleick, D. (1990) CGA-219417 Technical: Gene Mutation Test with Chinese Hamster
Cells V79: Amended: Lab Project Number: 901086. Unpublished study prepared by
Ciba-Geigy Ltd. 51 p.
43709037
Ogorek, B. (1990) CGA-219417 Technical: Salmonella and Escerichia/Liver--Microsome
Test: Amended: Lab Project Number: 901084. Unpublished study prepared by Ciba-
Geigy Ltd. 49 p.
43709038
Strasser, F. (1991) CGA-219417 Technical: Structural Chromosomal Aberration Test:
Cytogenic Test on Chinese Hamster Cells in vitro: Amended: Lab Project Number:
901085. Unpublished study prepared by Ciba-Geigy Ltd. 43 p.
43709039
Ceresa, C. (1990) CGA-219417 Technical: Structural Chromosomal Aberration Test:
Micronucleus Test, Mouse in vivo Study: Amended: Lab Project Number: 901082.
Unpublished study prepared by Ciba-Geigy Ltd. 45 p.
45353505
Hertner, T. (1992) Salmonella and Escherichia/Liver-Microsome Test: CGA-249287
Technical: Final Report: Lab Project Number: 923089: 530-92. Unpublished study
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45353506
Hertner, T. (1994) Salmonella and Escherichia/Mammalian-Microsome Mutagenicity
Test: CGA-263208 Technical: Final Report: Lab Project Number: 943052: 530-94.
Unpublished study prepared by Novartis Crop Protection AG. 72 p. {OPPTS 870.5100}
45353507
Hertner, T. (1994) Salmonella and Escherichia/Mammalian-Microsome Mutagenicity
Test: CGA-232449 Technical: Final Report: Lab Project Number: 943108: 531-94.
Unpublished study prepared by Novartis Crop Protection AG. 80 p. {OPPTS 870.5100}
45353508
Deparade, E. (2000) Salmonella and Escherichia/Mammalian-Microsome Mutagenicity
Test: NOA 422054 Technical: Final Report: Lab Project Number: 20003021: 946-00.
Unpublished study prepared by Novartis Crop Protection AG. 65 p. {OPPTS 870.5100}
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43709040
Thanei, P. (1992) Absorption, Distribution, Metabolism, and Excretion of (U-(carbon
14))Phenyl and (2-(carbon 14))Pyrimidyl CGA-219417 in the Rat: Lab Project Number:
08PT01: 08PT02: 08PT/03. Unpublished study prepared by Ciba-Geigy Ltd. 154 p.
43709041
Mueller, T. (1992) The Metabolism of (U-(carbon 14))Phenyl CGA-219417 and (2-
(carbon 14))Pyrimidyl CGA-219417 in the Rat: Lab Project Number: 13/92: 03TM01: PR
13/92. Unpublished study prepared by Ciba-Geigy Ltd. 68 p.
44867315
Allen, J.; East, P.; Francis, R. et al. (1975) Metabolism of Debrisoquine Sulfate:
Identification of Some Urinary Metabolites in Rat and Man. Drug Metabolism and
Disposition 3(5):332-337.
85-3       Dermal Penetration/Absorption
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45906102
Mewes, K. (1999) Dermal Absorption of (Phenyl-U-(Carbon 14)) CGA 219417
Formulated as Switch 62.5 WG (A-9219 B) in the Rat: Final Report: Lab Project
Number: 028AM04. Unpublished study prepared by Novartis Crop Protection AG. 53 p.
{OPPTS 870.7600}
45906103
Mewes, K. (1999) The In Vitro Percutaneous Absorption of (Phenyl-U-(Carbon 14)) CGA
219417 Formulated as Switch 62.5 WG (A-9219 B) Through Rat and Human Epidermis:
Final Report: Lab Project Number: 028AM05. Unpublished study prepared by Novartis
Crop Protection AG. 47 p.
Page 38 of 38


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Rules and Regulations]
[Page 50932-50933]
[DOCID:fr18au10-29]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R01-RCRA-2010-0468-FRL-9190-6]

Massachusetts: Final Authorization of State Hazardous Waste
Management Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Commonwealth of Massachusetts applied to EPA for final

authorization of certain changes to its hazardous waste program under
the Resource Conservation and Recovery Act (RCRA). EPA determined that
these changes satisfy all requirements needed to qualify for final
authorization and recently authorized the State's changes through an
immediate final action. In the immediate final action, EPA also stated
that ``Massachusetts is not authorized to carry out its hazardous waste
program in Indian country.'' An adverse comment was filed regarding
this determination (but not otherwise challenging the authorization
decision). Therefore, EPA is today responding to this comment and
making a final decision that the updated authorization does not apply
to Indian country. In addition, EPA is correcting an error in the
immediate final action rule.

DATES: The authorization of Massachusetts' program revisions shall
continue to take effect on August 23, 2010 as provided in the immediate
final rule. Today's decision that the updated authorization does not
apply to Indian country also will be final, effective August 23, 2010.

ADDRESSES: Docket: EPA has established a docket for this action under
Docket ID No. EPA-R01-RCRA-2010-0468. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although it may be
listed in the index, some information might not be publicly available,
e.g., CBI or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the following two locations: (i) Massachusetts Department of
Environmental Protection, Business Compliance Division, One Winter
Street--8th Floor, Boston, MA 02108, business hours Monday through
Friday 9 a.m. to 5 p.m., tel:<PHONE_NUMBER>; and (ii) EPA Region I
Library, 5 Post Office Square, 1st Floor, Boston, MA 02109-3912, by
appointment only,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Robin Biscaia, RCRA Waste Management
Section, Office of Site Remediation and Restoration (OSRR 07-1), EPA
New England--Region 1, 5 Post Office Square, Suite 100, Boston, MA
02109-3912; telephone number:<PHONE_NUMBER>; fax number: (617) 918-
0642, e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Massachusetts program revisions
authorized by EPA through the recent immediate final action are
identified in the immediate final rule, 75 FR 35660 (June 23, 2010).
Since no adverse comments were received regarding EPA's decision to
authorize these revisions, the decision to authorize the revisions is
not being withdrawn and will continue to take effect on August 23, 2010
as provided in the immediate final rule.
    However, in the immediate final rule, EPA also stated that
``Massachusetts is not authorized to carry out its hazardous waste
program in Indian country within the State (land of the Wampanoag
Tribe). Therefore, EPA will continue to implement and administer the
RCRA program in these lands.'' Id. at 35665. An adverse comment was
received regarding this determination, worded as follows: ``Through
federalism, Massachusetts as one of the 50 sovereign united States,
should have the authority to protect its residents from hazardous waste
contaminating our water and air within our boundaries. Whenever the
Massachusetts regulations exceed the Federal regulations or are
broader, the EPA through comity should be enforcing the higher
Massachusetts standards within Indian country.'' Since an adverse
comment was received on this issue, the determination regarding whether
the authorization applies within Indian country will not take effect as
a final decision based on the immediate final rule. Rather, EPA instead
has considered the comment and is making its final determination
regarding the effect of the authorization decision on Indian country in
today's final rule.
    Massachusetts has not applied for authority to operate its RCRA
program within Indian country. In the absence of any request from the
State, the EPA has no occasion for considering whether it would grant
Massachusetts such authority. Thus, in the absence of any request from
the State, the EPA cannot agree with the commenter that Massachusetts
should be granted the authority to operate its program in Indian
country. Rather, the EPA administered RCRA program will continue to
apply in those lands.
    The EPA also cannot agree with the commenter that it should be
enforcing the Massachusetts requirements rather than the Federal RCRA
requirements, within Indian country. As a legal matter, for areas where
the EPA directly administers the RCRA program, the EPA must enforce its
own requirements rather than a State's requirements.
    Thus, the EPA is today making the final determination that
Massachusetts is not authorized to carry out its hazardous waste
program in Indian country within the State (land of the Wampanoag
Tribe). Therefore, EPA will continue to implement and administer the
RCRA program in these lands. This determination affects only the land
in the town of Gay Head (Aquinnah), Massachusetts, taken into trust by
the Department of the Interior for the Wampanoag Tribal Council of Gay
Head, Inc., as authorized by the Wampanoag Tribal Council of Gay Head,
Inc., Indian Claims Settlement Act of 1987. See 25 U.S.C. 1771-1771i.
    In addition, EPA is today correcting an error in the immediate
final action rule. At page 35664 of that rule, the EPA authorized the
State to regulate waste codes P188, Physostigmine Salicylate, and P204,
Physostigmine, under Checklist 140. However, on page 35663 of that
rule, the EPA erroneously stated that the State was not being
authorized for those two waste codes. This incorrect statement should
be disregarded. The authorization of the State to regulate those two
waste codes will take effect on August 23, 2010, along with the rest of
the immediate final rule.
    The ways in which the EPA has complied with various administrative
requirements regarding the authorization action is set out in part L.
of the immediate final rule. No further steps are required in order to
make today's final determination.

List of Subjects in 40 CFR Part 271

    Environmental protection, Hazardous waste, Indian lands.

    Authority: This action is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: August 9, 2010.
Ira W. Leighton,
Acting Regional Administrator, EPA New England.
[FR Doc. 2010-20469 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 104 (Wednesday, May 31, 2023)]
[Notices]
[Pages 34882-34883]
[FR Doc No: 2023-11532]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4700-DR; Docket ID FEMA-2023-0001]

Arkansas; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Arkansas

(FEMA-4700-DR), dated April 4, 2023, and related determinations.

DATES: The declaration was issued April 4, 2023.

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: Notice is hereby given that, in a letter
dated April 4, 2023, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Arkansas resulting from a severe winter storm during the period
of January 30 to February 2, 2023, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Arkansas.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Roland W. Jackson, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Arkansas have been designated
as adversely affected by this major disaster:

    Bradley, Calhoun, Cleveland, Dallas, Desha, Drew, Grant,
Jefferson, Lincoln, Nevada, Ouachita, Searcy, and Stone Counties for
Public Assistance.
    All areas within the State of Arkansas are eligible for
assistance under the Hazard Mitigation Grant Program.

    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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-11532 Filed 5-30-23; 8:45 am]
BILLING CODE 9111-23-P