[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Notices]
[Page 30416]
[DOCID:fr01jn10-88]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1916-DR; Docket ID FEMA-2010-0002]

Mississippi; Amendment No. 1 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 Mississippi (FEMA-1916-DR), dated May 14, 2010, and
related determinations.

DATES: Effective Date: May 24, 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 notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 14, 2010.

Marshall and Union Counties for Public Assistance.
    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. 2010-13035 Filed 5-28-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: February 15, 2007 (Volume 72, Number 31)]
[Notices]
[Page 7467-7468]
[DOCID:fr15fe07-99]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0010]

Federal Advisory Council on Occupational Safety and Health

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of meeting.

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SUMMARY: The Federal Advisory Council on Occupational Safety and Health
(FACOSH) will meet March 1, 2007, in Washington, DC.

DATES:
    FACOSH meeting: FACOSH will meet from 10 a.m. to 4 p.m., Thursday,
March 1, 2007.
    Submission of comments and requests to speak: Comments and requests
to speak at the FACOSH meeting must be received by February 22, 2007.

ADDRESSES:
    FACOSH meeting: FACOSH will meet in Rooms N-3437 A/B/C, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210.
    Submission of comments and requests to speak: Comments and requests
to speak at the FACOSH meeting, identified by OSHA Docket No. 2007-
0010, may be submitted by any of the following methods:
    Electronically: You may submit materials, including attachments,
electronically at: http://www.regulations.gov, the Federal eRulemaking

Portal. Follow the online instructions for making submissions.
    Facsimile: If your submission, including attachments, is not longer
than 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Mail, express delivery, hand delivery, messenger or courier
service: Submit three copies of your submissions to the OSHA Docket
Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone<PHONE_NUMBER> (OSHA's TTY number
is<PHONE_NUMBER>). Deliveries (hand, express mail, messenger and
courier service) are accepted during the Department of Labor's and
Docket Office's normal business hours, 8:15 a.m.-4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and
docket number for this Federal Register notice (Docket No. OSHA-2007-
0010). Submissions in response to this Federal Register notice,
including personal information provided, will be posted without change
at: http://www.regulations.gov. Therefore, OSHA cautions interested

parties about submitting personal information such as social security
numbers and birth dates. Because of security-related procedures,
submissions by regular mail may result in a significant delay in their
receipt. Please contact the OSHA Docket Office, at the address above,
for information about security procedures for making submissions by
hand delivery, express delivery, and messenger or courier service. For
additional information on submitting comments and requests to speak,
see the SUPPLEMENTARY INFORMATION section below.
    Docket: To read or download submissions, go to http://www.regulations.gov.
 All documents in the docket are listed in the

http://www.regulations.gov index. Although listed in the index, some

documents (e.g., copyrighted material) are not publicly available to
read or download through http://www.regulations.gov. All submissions,

including copyrighted material, are available for inspection and
copying at the OSHA Docket Office at the address above.

FOR FURTHER INFORMATION CONTACT: For general information: Diane
Brayden, Director, OSHA, Office of Federal Agency Programs, U.S.
Department of Labor, Room N-3622, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>For special accommodations for the FACOSH meeting:
Veneta Chatmon, OSHA, Office of Communications, Room N-3647, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FACOSH will meet Thursday, March 1, 2007, in
Washington, DC. All FACOSH meetings are open to the public.
    FACOSH is authorized by section 19 of the Occupational Safety and
Health Act of 1970 (OSH Act) (29 U.S.C. 668), 5 U.S.C. 7902, and
Executive Order 12196 to advise the Secretary of Labor on all matters
relating to the occupational safety and health of Federal employees
(Ex. 2). This includes providing advice on how to reduce and keep to a
minimum the number of injuries and illnesses in the Federal workforce
and how to encourage the establishment and maintenance of effective
occupational safety and health programs in each Federal Department and
Agency (Ex. 3).
    The tentative agenda for the FACOSH meeting includes:
     Safety, Health and Return-to-Employment (SHARE)
Initiative,
     Recordkeeping,
     Training,
     Field Federal Safety and Health Councils, and
     Facility Safety and Health Design.
    FACOSH meetings are transcribed and detailed minutes of the
meetings are prepared. Meeting transcripts and minutes are included in
the official record of FACOSH meetings.
    Interested parties may submit a request to make an oral
presentation to FACOSH by one of the methods listed in the ADDRESSES
section above. The request must state the amount of time requested to
speak, the interest represented (e.g., business or organization name),
if any, and a brief outline of the presentation. Requests to address
FACOSH may be granted as time permits and at the discretion of the
FACOSH chair.
    Interested parties also may submit comments, including data and
other information, using any of the methods listed in the ADDRESSES
section above. OSHA will provide all submissions to FACOSH members.
    Individuals who need special accommodations and wish to attend the

FACOSH meeting should contact Veneta Chatmon, at the address above, at
least seven days before the meeting.
    Public Participation--Submissions and Access to Official Meeting
Record:
    You may submit comments and requests to speak (1) electronically,
(2) by facsimile, or (3) by hard copy. All submissions, including
attachments and other materials, must identify the Agency name and the
OSHA docket number for this notice (Docket No. OSHA-2007-0010). You may
supplement electronic submissions by uploading documents
electronically. If, instead, you wish to submit hard copies of
supplementary documents, you must submit three copies to the OSHA
Docket Office using the instructions in the ADDRESSES section above.
The additional materials must clearly identify your electronic
submission by name, date and docket number.
    Because of security-related procedures, the use of regular mail may
cause a significant delay in the receipt of submissions. For
information about security procedures concerning the delivery of
submissions by hand, express delivery, messenger or courier service,
please contact the OSHA Docket Office at<PHONE_NUMBER> (TTY (877) 889-
5627).
    Meeting transcripts and minutes as well as submissions in response
to this Federal Register notice are included in the official record of
the FACOSH meeting (Docket No. OSHA-2007-0010). Submissions are posted
without change at: http://www.regulations.gov. Therefore, OSHA cautions

interested parties about submitting personal information such as social
security numbers and birth dates. Although all submissions are listed
in the http://www.regulations.gov index, some documents (e.g.,

copyrighted material) are not publicly available to read or download
through http://www.regulations.gov. All submissions, including

copyrighted material, are available for inspection and copying at the
OSHA Docket Office.
    Exhibits referenced in this Federal Register notice are included in
Docket No. OSHA-2007-0010, which is the ``Docket ID'' number in http://www.regulations.gov.
 Exhibit numbers are listed at the beginning of the

title of the specific document in the http://www.regulations.gov index

(see ``Document Title'' column).
    Information on using the http://www.regulations.gov Website to make

submissions and to access the docket and exhibits is available at the
Website's User Tips link. Contact the OSHA Docket Office for
information about materials not available through the Website and for
assistance in using the Internet to locate submissions and other
documents in the docket. Electronic copies of this Federal Register
notice are available at: http://www.regulations.gov. This notice, as

well as news releases and other relevant information, is also available
at OSHA's Webpage at: http://www.osha.gov.

    Authority and Signature: Edwin G. Foulke, Jr., Assistant Secretary
of Labor for Occupational Safety and Health, directed the preparation
of this notice under the authority granted by section 19 of the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 668), 5
U.S.C. 7902, section 1-5 of Executive Order 12196, the Federal Advisory
Committee Act (5 U.S.C. App.2) and Secretary of Labor's Order No. 2-
2002 (67 FR 65008).

    Signed at Washington, DC, this 12th day of February, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor.
[FR Doc. E7-2674 Filed 2-14-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Pages 80662-80664]
[FR Doc No: 2016-27545]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0511; FRL-9954-84]

Certain New Chemicals or Significant New Uses; Statements of
Findings for October 2016

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5(g) of the Toxic Substances Control Act (TSCA)
requires

EPA to publish in the Federal Register a statement of its findings
after its review of TSCA section 5(a) notices when EPA makes a finding
that a new chemical substance or significant new use is not likely to
present an unreasonable risk of injury to health or the environment.
Such statements apply to premanufacture notices (PMNs), microbial
commercial activity notices (MCANs), and significant new use notices
(SNUNs) submitted to EPA under TSCA section 5. This document presents
statements of findings made by EPA on TSCA section 5(a) notices during
the period from September 20, 2016 to October 24, 2016.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Greg Schweer, Chemical Control
Divison (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the PMNs addressed in this
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0511, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    This document lists the statements of findings made by EPA after
review of notices submitted under TSCA section 5(a) that certain new
chemical substances or significant new uses are not likely to present
an unreasonable risk of injury to health or the environment. This
document presents statements of findings made by EPA during the period
from September 20, 2016 to October 24, 2016.

III. What is the agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a)
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
     The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
     The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
    Unreasonable risk findings must be made without consideration of
costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
under the conditions of use. The term ``conditions of use'' is defined
in TSCA section 3 to mean ``the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal
Register a statement of its findings after its review of a TSCA section
5(a) notice when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to
premanufacture notices (PMNs), microbial commercial activity notices
(MCANs), and significant new use notices (SNUNs) submitted to EPA under
TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA as a significant new use must submit a
notice to EPA at least 90 days before commencing manufacture of the new
chemical substance or before engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name, if the specific name is
claimed as CBI).
     Web site link to EPA's decision document describing the
basis of the ``not likely to present an unreasonable risk'' finding
made by EPA under TSCA section 5(a)(3)(C).
    EPA Case Number: J-16-0019; Chemical identity: Trichoderma reesei
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-20.
    EPA Case Number: J-16-0020; Chemical identity: Trichoderma reesei
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-21.
    EPA Case Number: J-16-0021; Chemical identity: Trichoderma reesei
modified (generic name); Web site link: https://www.epa.gov/reviewing-
new-

chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-
determination-22.
    EPA Case Number: J-16-0022; Chemical identity: Trichoderma reesei
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-23.
    EPA Case Number: J-16-0023; Chemical identity: Trichoderma reesei
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-24.
    EPA Case Number: P-16-0459; Chemical identity: Carbomonocyclic
dicarboxylic acid, polymer with alkanedioic acid, substituted
heteropolycycle, substituted carbomonocycle, alkyl alkenoate,
alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated
substituted dicarbomonocycle, alkenoic acid, oxo alkyl initiated
(generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-19.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: November 8, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2016-27545 Filed 11-15-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11561-11562]
[FR Doc No: 2016-04903]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9943-37-Region 1]

Proposed Cercla Administrative Cost Recovery Settlement: Former
Athol Rod and Gun Club Superfund Site, Athol, Massachusetts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement; request for public comments.

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SUMMARY: Notice is hereby given of a proposed administrative cost
settlement for recovery of response costs concerning the Former Athol
Rod and Gun Club Superfund Site, located in Athol, Worcester County,
Massachusetts with the Settling Party the Town of

Athol. The proposed settlement requires the Settling Party to pay the
Environmental Protection Agency (EPA) $275,000, plus interest, to the
Hazardous Substance Superfund to settle EPA's past response costs,
which currently amount to $3,434,307.47. In exchange, EPA will provide
the Settling Party with a covenant not to sue for past costs. The
settlement has been approved by the Environmental and Natural Resources
Division of the United States Department of Justice. For 30 days
following the date of publication of this notice, the Agency will
receive written comments relating to the settlement for recovery of
response costs. The Agency will consider all comments received and may
modify or withdraw its consent to this cost recovery settlement if
comments received disclose facts or considerations which indicate that
the settlement is inappropriate, improper, or inadequate. The Agency's
response to any comments received will be available for public
inspection at the Athol Public Library, 568 Main Street, Athol, MA
01331 and at the Environmental Protection Agency--Region I, 5 Post
Office Square, Suite 100, Boston, MA 02109-3912.

DATES: Comments must be submitted by April 4, 2016.

ADDRESSES: Comments should be addressed to Peter DeCambre, Enforcement
Counsel, U.S. Environmental Protection Agency, 5 Post Office Square,
Suite 100 (OES04-2), Boston, MA 02109-3912 (Telephone No.<PHONE_NUMBER>)
and should reference the Former Athol Rod and Gun Club Site, U.S. EPA
Docket No: 01-2016-0003.

FOR FURTHER INFORMATION CONTACT: A copy of the proposed settlement may
be obtained from Stacy Greendlinger, Office of Site Remediation and
Restoration, U.S. Environmental Protection Agency, Region I, 5 Post
Office Square, Suite 100 (OSRR02-2), Boston, MA 02109-3912, (617) 918-
1403<EMAIL_ADDRESS>Technical questions can also be
directed to Stacy Greendlinger. For legal questions, Peter DeCambre,
Office of Environmental Stewardship, U.S. Environmental Protection
Agency, Region I, 5 Post Office Square, Suite 100 (OES04-3), Boston, MA
02109-3912,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed administrative settlement for
recovery of past response costs concerning the Former Athol Rod and Gun
Club Superfund Site, located in Athol, Worcester County, Massachusetts
is made in accordance with Section 122(h)(l) of the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA). EPA
covenants not to sue or take administrative action against the Settling
Party, the Town of Athol, pursuant to Section 107(a) of CERCLA, 42
U.S.C. 9607(a), for Past Response Costs. In exchange, the Settling
Party agrees to pay EPA $275,000, plus interest running from the
effective date of the Settlement Agreement through the date of payment.
The Town will pay $100,000 thirty days after the effective date of the
Settlement Agreement, and $87,500 a year later, and a final $87,500 a
year plus interest for each installment. For 30 days following the date
of publication of this notice, the Agency will receive written comments
relating to the settlement for recovery of response costs.

    Dated: February 1, 2016.
Bryan Olson,
Director, Office of Site Remediation and Restoration.
[FR Doc. 2016-04903 Filed 3-3-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4927-4928]
[FR Doc No: 2015-01626]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0115]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff--Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Principle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
concerning class II special controls for an automated blood cell
separator device operating by centrifugal or filtration separation
principle.

DATES: Submit either electronic or written comments on the collection
of information by March 30, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Springs, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under 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 provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry and FDA Staff--Class II Special Controls Guidance
Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle (OMB Control Number
0910-0594)--Extension

    Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), FDA
may

establish special controls, including performance standards, postmarket
surveillance, patient registries, guidelines, and other appropriate
actions it believes necessary to provide reasonable assurance of the
safety and effectiveness of the device. The special control guidance
serves to support the reclassification from class III to class II of
the automated blood cell separator device operating on a centrifugal
separation principle intended for the routine collection of blood and
blood components as well as the special control for the automated blood
cell separator device operating on a filtration separation principle
intended for the routine collection of blood and blood components
reclassified as class II (Sec.  864.9245 (21 CFR 864.9245)).
    For currently marketed products not approved under the premarket
approval process, the manufacturer should file with FDA, for 3
consecutive years, an annual report on the anniversary date of the
device reclassification from class III to class II or on the
anniversary date of the 510(k) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360) clearance. Any subsequent change to
the device requiring the submission of a premarket notification in
accordance with section 510(k) of the FD&C Act should be included in
the annual report. Also, a manufacturer of a device determined to be
substantially equivalent to the centrifugal or filtration-based
automated cell separator device intended for the routine collection of
blood and blood components should comply with the same general and
special controls.
    The annual report should include, at a minimum, a summary of
anticipated and unanticipated adverse events that have occurred and
that are not required to be reported by manufacturers under Medical
Device Reporting (MDR) (part 803 (21 CFR part 803)). The reporting of
adverse device events summarized in an annual report will alert FDA to
trends or clusters of events that might be a safety issue otherwise
unreported under the MDR regulation.
    Reclassification of this device from class III to class II for the
intended use of routine collection of blood and blood components
relieves manufacturers of the burden of complying with the premarket
approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e),
and may permit small potential competitors to enter the marketplace by
reducing the burden. Although the special control guidance recommends
that manufacturers of these devices file with FDA an annual report for
3 consecutive years, this would be less burdensome than the current
postapproval requirements under part 814, subpart E (21 CFR part 814,
subpart E), including the submission of periodic reports under Sec.
814.84.
    Collecting or transfusing facilities and manufacturers have certain
responsibilities under Federal regulations. For example, collecting or
transfusing facilities are required to maintain records of any reports
of complaints of adverse reactions (21 CFR 606.170), while the
manufacturer is responsible for conducting an investigation of each
event that is reasonably known to the manufacturer and evaluating the
cause of the event (Sec.  803.50(b)). In addition, manufacturers of
medical devices are required to submit to FDA individual adverse event
reports of death, serious injury, and malfunctions (Sec.  803.50).
    In the special control guidance document, FDA recommends that
manufacturers include in their three annual reports a summary of
adverse reactions maintained by the collecting or transfusing facility,
or similar reports of adverse events collected, in addition to those
required under the MDR regulation. The MedWatch medical device
reporting code instructions (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106737.htm) contains a
comprehensive list of adverse events associated with device use,
including most of those events that we recommend summarizing in the
annual report.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                         Reporting activity                             Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Report......................................................               4                1                4                5               20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on FDA records, there are approximately four manufacturers of
automated blood cell separator devices. The estimated average burden
per response is based on the time that the manufacturers will spend
preparing and submitting the annual report.
    Other burden hours required for Sec.  864.9245 are reported and
approved under OMB control number 0910-0120 (premarket notification
submission 501(k), 21 CFR part 807, subpart E), and OMB control number
0910-0437 (MDR, part 803).

    Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01626 Filed 1-28-15; 8:45 am]
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[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38120-38121]
[FR Doc No: 2023-12472]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Membership in the National Parks Overflights Advisory Group

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Solicitation of applications.

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SUMMARY: The Federal Aviation Administration (FAA) and the National
Park Service (NPS) invite interested persons to apply to fill one
current and five upcoming vacancies on the National Parks Overflights
Advisory Group (NPOAG). This notice invites interested persons to apply
for the openings. The current opening is for a representative of Native
American tribes. The upcoming openings are for another representative
of Native American tribes, two representatives of the commercial air
tour operators, and three representatives of environmental concerns.

DATES: Persons interested in these membership openings will need to
apply by July 27, 2023.

FOR FURTHER INFORMATION CONTACT: Sandi Fox, Environmental Protection
Specialist, FAA Office of Environment and Energy, 800 Independence Ave.
SW, Suite 900W, Washington, DC 20591, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The National Parks Air Tour Management Act of 2000 (the Act) was
enacted on April 5, 2000, as Public Law 106-181, and subsequently
amended in the FAA Modernization and Reform Act of 2012. The Act
required the establishment of the advisory group within one year after
its enactment. The NPOAG was established in March 2001. The advisory
group is comprised of representatives of general aviation, commercial
air tour operators, environmental concerns, and Native American tribes.
The Administrator of the FAA and the Director of NPS (or their
designees) serve as ex officio members of the group. Representatives of
the Administrator and Director serve alternating 1-year terms as
chairman of the advisory group.
    In accordance with the Act, the advisory group provides ``advice,
information, and recommendations to the Administrator and the
Director--
    (1) On the implementation of this title [the Act] and the
amendments made by this title;

    (2) On commonly accepted quiet aircraft technology for use in
commercial air tour operations over a national park or tribal lands,
which will receive preferential treatment in a given air tour
management plan;
    (3) On other measures that might be taken to accommodate the
interests of visitors to national parks; and
    (4) At the request of the Administrator and the Director, safety,
environmental, and other issues related to commercial air tour
operations over a national park or tribal lands.''

Membership

    The current NPOAG is made up of one member representing general
aviation, three members representing commercial air tour operators,
four members representing environmental concerns, and two members
representing Native American tribes. Members serve three-year terms.
Current members of the NPOAG are as follows: Murray Huling representing
general aviation; Eric Lincoln, James Viola, and John Becker
representing commercial air tour operators; Robert Randall, Dick
Hingson, Les Blomberg, and John Eastman representing environmental
interests; and Carl Slater representing Native American tribes, with
one current opening for a Native American tribe representative. The
three-year terms of Mr. Becker, Mr. Blomberg, Mr. Eastman, Mr. Hingson,
and Mr. Viola expire on August 30, 2023.

Selections

    To retain balance within the NPOAG, the FAA and NPS are seeking
candidates interested in filling the one current vacant seat
representing Native American tribes, two upcoming vacancies
representing the commercial air tour industry, and three upcoming
vacancies representing environmental concerns. The FAA and NPS invite
persons interested in these openings on the NPOAG to contact the person
listed in the FOR FURTHER INFORMATION CONTACT section.
    Requests to serve on the NPOAG must be made in writing and
postmarked or emailed on or before July 27, 2023. Any request to fill
one of these seats must describe the requestor's affiliation with
commercial air tour operators, environmental concerns, or federally
recognized Native American tribes, as appropriate. The request should
also explain what expertise the requestor would bring to the NPOAG as
related to issues and concerns with aircraft flights over national
parks or tribal lands. The term of service for NPOAG members is 3
years. Members may re-apply for another term.
    On August 13, 2014, the Office of Management and Budget issued
revised guidance regarding the prohibition against appointing or not
reappointing federally registered lobbyists to serve on advisory
committees (79 FR 47482). Therefore, before appointing an applicant to
serve on the NPOAG, the FAA and NPS will require the prospective
candidate to certify that they are not a federally registered lobbyist.

    Issued in Washington, DC, on June 7, 2023.
Sandra Fox,
Environmental Protection Specialist, FAA Office of Environment and
Energy.
[FR Doc. 2023-12472 Filed 6-9-23; 8:45 am]
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