[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27785-27788]
[FR Doc No: 2019-12566]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2256]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by July
15, 2019, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by July 15, 2019. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2019.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to<EMAIL_ADDRESS>by mail to
Advisory Committee Oversight and Management Staff, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-0002, or by Fax: 301-
847-8640.
    Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002, or by Fax:<PHONE_NUMBER>. Additional information
about becoming a member of an FDA advisory committee can also be
obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    For questions relating to specific advisory committees or panels:
contact the appropriate contact person listed in table 1.

                  Table 1--Advisory Committee Contacts
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             Contact person                       Committee/panel
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Yinghua Wang, Center for Drug Evaluation  Arthritis Advisory Committee.
 and Research, Food and Drug
 Administration, 10903 New Hampshire
 Ave. Bldg. 31, Rm. 2412, Silver Spring,
 MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Kalyani Bhatt, Center for Drug            Bone, Reproductive and
 Evaluation and Research, Food and Drug    Urological Drugs Advisory
 Administration, 10903 New Hampshire       Committee;
 Ave., Bldg. 31, Rm. 2438, Silver          Psychopharmacologic Drugs
 Spring, MD 20993-0002,<PHONE_NUMBER>,      Advisory Committee.
 email<EMAIL_ADDRESS>Jennifer Shepherd, Center for Drug        Medical Imaging Drugs Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2434, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Lauren Hotaki, Center for Drug            Oncologic Drugs Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2426, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Cindy Chee, Center for Drug Evaluation    Pharmacy Compounding Advisory
 and Research, Food and Drug               Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2430, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Patricio Garcia, Center for Devices and   Clinical Chemistry and
 Radiological Health, Food and Drug        Clinical Toxicology Devices
 Administration, 10903 New Hampshire       Panel; Gastroenterology and
 Ave., Bldg. 66, Rm. G610, Silver          Urology Devices Panel;
 Spring, MD 20993-0002,<PHONE_NUMBER>,      Obstetrics and Gynecology
 email<EMAIL_ADDRESS>      Devices Panel.
Sara Anderson, Center for Devices and     Dental Products Devices Panel;
 Radiological Health, Food and Drug        National Mammography Advisory
 Administration, 10903 New Hampshire       Committee; Orthopaedic and
 Ave., Bldg. 66, Rm. G616, Silver          Rehabilitation Devices Panel.
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Evella Washington, Center for Devices     Circulatory Systems Devices
 and Radiological Health, Food and Drug    Panel.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. G640, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Joannie Adams-White, Center for Devices   Medical Devices Dispute
 and Radiological Health, Food and Drug    Resolution Panel.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5519, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Aden Asefa, Center for Devices and        Immunology Devices Panel;
 Radiological Health, Food and Drug        Microbiology Devices Panel;
 Administration, 10903 New Hampshire       Radiological Devices Panel.
 Ave., Bldg. 66, Rm. G642, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
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     Committee/panel/areas of expertise needed             Type of vacancy            Approximate date needed
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Arthritis Advisory Committee--Knowledgeable in the  1--Voting....................  September 30, 2019.
 fields of arthritis, rheumatology, orthopedics,
 epidemiology or statistics, analgesics, and
 related specialties.
Bone, Reproductive and Urological Drugs Advisory    1--Voting....................  Immediately.
 Committee--Knowledgeable in the fields of
 obstetrics, gynecology, endocrinology,
 pediatrics, epidemiology or statistics, and
 related specialties.
Psychopharmacologic Drugs Advisory Committee--      1--Voting....................  June 30, 2019.
 Knowledgeable in the fields of
 psychopharmacology, psychiatry, epidemiology or
 statistics, and related specialties.
Medical Imaging Drugs Advisory Committee--          1--Voting....................  Immediately.
 Knowledgeable in the fields of nuclear medicine,
 radiology, epidemiology, statistics, and related
 specialties.
Oncologic Drugs Advisory Committee--Knowledgeable   1--Voting....................  June 30, 2019.
 in the fields of general oncology, pediatric
 oncology, hematologic oncology, immunologic
 oncology, biostatistics, and other related
 professions.
Pharmacy Compounding Advisory Committee--           1--Voting....................  Immediately.
 Knowledgeable in the fields of pharmaceutical
 compounding, pharmaceutical manufacturing,
 pharmacy, medicine, and other related specialties.
Clinical Chemistry and Clinical Toxicology Devices  1--Non-Voting................  Immediately.
 Panel--Doctors of Medicine or Philosophy with
 experience in clinical chemistry (e.g., cardiac
 markers), clinical toxicology, clinical
 pathology, clinical laboratory medicine, and
 endocrinology.
Gastroenterology and Urology Devices Panel--        1--Non-Voting................  Immediately.
 Gastroenterologists, urologists, and
 nephrologists.
Obstetrics and Gynecology Devices Panel--Experts    1--Non-Voting................  Immediately.
 in perinatology, embryology, reproductive
 endocrinology, pediatric gynecology,
 gynecological oncology, operative hysteroscopy,
 pelviscopy, electro-surgery, laser surgery,
 assisted reproductive technologies,
 contraception, postoperative adhesions, and
 cervical cancer and colposcopy; biostatisticians
 and engineers with experience in obstetrics/
 gynecology devices; urogynecologists; experts in
 breast care; experts in gynecology in the older
 patient; experts in diagnostic (optical)
 spectroscopy; experts in midwifery; labor and
 delivery nursing.
Dental Products Device Panel--Dentists, engineers,  1--Non-Voting................  October 30, 2019.
 and scientists who have expertise in the areas of
 dental implants, dental materials,
 periodontology, tissue engineering, and dental
 anatomy.
National Mammography Advisory Committee--           1--Non-Voting................  Immediately.
 Physician, practitioner, or other health
 professional whose clinical practice, research
 specialization, or professional expertise
 includes a significant focus on mammography.
Orthopaedic and Rehabilitation Devices Panel--      1--Non-Voting................  Immediately.
 Orthopedic surgeons (joint spine, trauma, and
 pediatric); rheumatologists; engineers
 (biomedical, biomaterials, and biomechanical);
 experts in rehabilitation medicine, sports
 medicine, and connective tissue engineering; and
 biostatisticians.
Circulatory Systems Devices Panel--Interventional   1--Non-Voting................  Immediately.
 cardiologists, electrophysiologists, invasive
 (vascular) radiologists, vascular and
 cardiothoracic surgeons, and cardiologists with
 special interest in congestive heart failure.
Medical Devices Dispute Resolution--Experts with    1--Non-Voting................  Immediately.
 broad, cross-cutting scientific, clinical,
 analytical, or mediation skills.
Immunology Devices Panel--Persons with experience   1--Non-Voting................  Immediately.
 in medical, surgical, or clinical oncology,
 internal medicine, clinical immunology, allergy,
 molecular diagnostics, or clinical laboratory
 medicine.
Microbiology Devices Panel--Clinicians with an      1--Non-Voting................  Immediately.
 expertise in infectious disease, e.g., pulmonary
 disease specialists, sexually transmitted disease
 specialists, pediatric infectious disease
 specialists, experts in tropical medicine and
 emerging infectious diseases, mycologists;
 clinical microbiologists and virologists;
 clinical virology and microbiology laboratory
 directors, with expertise in clinical diagnosis
 and in vitro diagnostic assays, e.g.,
 hepatologists; molecular biologists.
Radiology Devices Panel--Physicians with            1--Non-Voting................  Immediately.
 experience in general radiology, mammography,
 ultrasound, magnetic resonance, computed
 tomography, other radiological subspecialties and
 radiation oncology; scientists with experience in
 diagnostic devices, radiation physics,
 statistical analysis, digital imaging, and image
 analysis.
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I. Functions and General Description of the Committee Duties

A. Arthritis Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of arthritis, rheumatism, and related diseases.

B. Bone, Reproductive and Urologic Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of
obstetrics, gynecology, and related specialties.

C. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
practice of psychiatry and related fields.

D. Medical Imaging Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.

E. Oncologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of cancer.

F. Pharmacy Compounding Advisory Committee

    Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.

G. Certain Panels of the Medical Devices Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
may also make appropriate recommendations to the Commissioner of Food
and Drugs on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES section of this document), and a list
of consumer or community-based organizations for which the candidate
can demonstrate active participation.
    Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms up to 4 years.

    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12566 Filed 6-13-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7289-7290]
[FR Doc No: 2018-03362]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Commercial Driver's License Standards; Waiver for States To
Facilitate the Issuance of Licensing Documents to Former Residents of
Puerto Rico

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; grant of waiver.

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SUMMARY: FMCSA grants a limited 90-day waiver from certain requirements
concerning proof of U.S. citizenship or legal permanent residence and
domicile to enable State driver licensing agencies (SDLAs) to accept
commercial learner's permit (CLP) and commercial driver's license (CDL)
applications from individuals relocating from Puerto Rico as a result
of hurricanes Irma and Maria. This action is being taken in response to
a request from the Commercial Vehicle Training Association (CVTA) to
assist residents of Puerto Rico relocating from the U.S. territory to
any of the States in the aftermath of hurricanes Irma and Maria.
Through this waiver, the SDLAs may follow the Department of Homeland
Security's exception process for persons who, for reasons beyond their
control, are unable to present proof of legal permanent residency or
U.S. citizenship. Further, this waiver provides a procedure under which
persons who intend to domicile in the State of application may receive
additional time to provide proof establishing that the State of
application is the State of domicile. A CLP document issued under this
waiver may not be valid for more than 90 days and must require the
applicant to be actively enrolled in a CDL training school within that
State. A CDL document issued under this waiver may not be valid for
more than six months, by which time the individual is required to
provide proof as required under existing regulations that the State
that issued the CDL is his/her State of domicile. All other CLP and CDL
licensing requirements must be satisfied upon initial issuance of the
CLP or CDL. The Agency has determined that the waiver is within the
public interest and would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved by
complying with the regulation, based on the terms and conditions
imposed.

DATES: This waiver is applicable February 20, 2018 and expires on May
21, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Nikki McDavid, Chief of the
Commercial Driver's License Division, Office of Safety Programs, 202-
366-0831, Federal Motor Carrier Safety Administration, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Legal Basis

    The Transportation Equity Act for the 21st Century (TEA-21) (Pub.
L. 105-178, 112 Stat. 107, June 9, 1998) provides the Secretary of
Transportation (the Secretary) the authority to grant waivers from any
of the Federal Motor Carrier Safety Regulations (FMCSRs) issued under
Chapter 313 of Title 49 of the United States Code or 49 U.S.C. 31136,
to a person(s) seeking regulatory relief. 49 U.S.C. 31315(a). The
Secretary must make a determination that the waiver is in the public
interest, and that it is likely to achieve a level of safety that is
equivalent to, or greater than, the level of safety that would be
obtained in the absence of the waiver. Individual waivers may only be
granted for a specific unique, non-emergency event, for a period up to
three months. TEA-21 authorizes the Secretary to grant waivers without
requesting public comment, and without providing public notice.
    The Administrator of FMCSA has been delegated authority under 49
CFR 1.73(g) to carry out the functions vested in the Secretary by 49
U.S.C. chapter 311, subchapters I and III, relating to commercial motor
vehicle programs and safety regulation.

Background

    The FMCSA received an application for both a waiver and an
exemption from the CVTA. The CVTA requested relief from FMCSA's CDL
requirements concerning proof of U.S. citizenship and domicile in the
State that issues the CLP or CDL to enable citizens of Puerto Rico to
seek training at commercial driving schools in any of the 50 States or
the District of Columbia. Elsewhere in today's issue of the Federal
Register FMCSA seeks public comment on CVTA's exemption application.
    Currently, FMCSA requires individuals seeking a CLP or CDL to
provide the State of application proof of citizenship or legal
permanent residency. The FMCSRs include a list of

acceptable documents States may accept as proof of citizenship or legal
permanent residency (see Table 1 to 49 CFR 383.71). FMCSA also requires
each person to provide proof that the State to which the CLP or CDL
application is submitted is his/her State of domicile. The State must
require compliance with the standards for establishing proof of
citizenship or legal permanent residency, and domicile.
    In the aftermath of hurricanes Irma and Maria, a number of
residents of Puerto Rico have or will soon relocate from the U.S.
Territory to one of the States. Some of these residents may wish to
pursue a career as a commercial motor vehicle driver upon arrival in
any of the States. However, because of the hurricanes, these
individuals may not possess certain documents otherwise necessary to
establish U.S. citizenship or legal permanent residency under the CLP
and CDL regulations. Similarly, the former residents impacted by the
hurricanes may not be immediately capable of providing documentation
establishing domicile within the application State under the CLP and
CDL regulations.

CVTA's Request

    The CVTA requests that FMCSA provide a limited 90-day waiver
allowing the SDLAs the same flexibility that the DHS provides in its
Real ID rules (see 6 CFR 37.11(h)), when, for reasons beyond their
control, an applicant for a Real ID is unable to present necessary
documents and must rely on alternate methods to establish identity. The
CVTA also asks FMCSA to issue a waiver allowing CLP candidates to
provide a temporary address for the purposes of obtaining the CLP and
CDL. The organization suggests that States limit the duration of the
CDL document to 6 months before it must be renewed and require a long-
term or permanent address at that time. CVTA argues that the
limitations of the waiver would achieve the requisite level of safety
by preventing individuals from maintaining a CDL with no known
permanent address.

FMCSA Decision

    FMCSA has reviewed the CVTA request and DHS' exception process in 6
CFR 37.11(h)) and concluded that the waiver is needed to address the
unique, non-emergency situation caused by hurricanes Irma and Maria.
The aftermath of those hurricanes resulted in a significant number of
citizens of Puerto Rico relocating to various States. While FMCSA's
rules under 49 CFR part 383 do not include an exception process for
proof of U.S. citizenship or legal permanent residence for individuals
seeking a CLP or CDL, the Agency believes the DHS exception process in
6 CFR 37.11(h) provides a proven alternative for use in dealing with
individuals who, for reasons beyond their control, are unable to
present the required documents and must rely on alternate methods to
establish U.S. citizenship or legal permanent residence. Because the
exception process has been proven effective by DHS and the States,
FMCSA believes the waiver would achieve the requisite level of safety
provided by complying with 383.71(a)(2)(v), 49 CFR 383.71(b)(9), 49 CFR
383.73(a)(2)(vi), and 49 CFR 383.73(b)(6) concerning proof of U.S.
citizenship or legal permanent residence.
    Because the initial relocation from Puerto Rico would take place
shortly before the drivers begin the training necessary to obtain a
CLP, these individuals likely will be unable to provide the
documentation necessary to establish a ``State of domicile'' as defined
in 49 CFR 383.5 prior to the completion of the CDL training program and
the acceptance of a job driving commercial motor vehicles. The CVTA's
request suggests a 6-month period for those individuals obtaining a CDL
to provide proof of permanent domicile within a State, subsequently
updating the CDL record with a permanent address and thereby satisfying
the domicile requirements. FMCSA believes the 6-month limitation, the
States' use of the DHS exceptions for these CDL applicants to provide
legal permanent residence or U.S. citizenship, and the other conditions
stated below would achieve the requisite level of safety that would
otherwise be provided by requiring proof of domicile at the time of
application under 49 CFR 383.71(a)(2)(vi), 49 CFR 383.71(b)(10), 49 CFR
383.73(a)(2)(vi), and 49 CFR 383.73(b)(6).

Terms and Conditions of the Waiver

    FMCSA grants former residents of Puerto Rico relocating as a result
of hurricanes Irma and Maria a limited 90-day waiver from 49 CFR
383.71(a)(2)(v) and 383.71(b)(9) concerning proof of U.S. citizenship
or legal permanent residence. FMCSA also grants SDLA's a limited 90-day
waiver from 49 CFR 383.73(a)(2)(vi) and 383.73(b)(6) concerning proof
of U.S. citizenship or legal permanent residence. SDLAs choosing to
assist Puerto Rican citizens under this waiver must follow DHS's
exception process.
    FMCSA grants former residents of Puerto Rico relocating as a result
of hurricanes Irma and Maria, a limited 90-day waiver from the
requirement to provide proof of domicile at the time of application
under 49 CFR 383.71(a)(2)(vi) and 383.71(b)(10). FMCSA also grants
SDLAs a limited 90-day waiver from 49 CFR 383.73(a)(vi), 383.73(b)(6)
and authorizes them to extend the time within which an applicant must
provide proof of domicile and issue a CLP or CDL under the limitations
set forth in this waiver. Under this waiver, at the time of
application, the CLP applicant must be actively enrolled in a CDL
training school within the State of application and provide proof of
that enrollment. A CLP document issued under this waiver may not be
valid for more than 90 days. The CLP must include all other CLP
regulatory requirements. Should any individual with a CLP granted under
this waiver leave the training program for any reason prior to earning
a CDL, the CLP shall be cancelled by the SDLA immediately. The SDLA
shall be responsible for implementing any procedures within the State
to ensure compliance with this requirement.
    A CDL issued under this waiver is limited to six months validity
and may not be renewed unless the State complies with 383.73(b)(6) and
requires the individual to comply with 49 CFR 383.71(a)(2)(vi) by
providing proof that the State to which the application is made is the
applicant's State of domicile as defined by 383.5. The SDLA must submit
to [email protected] a list of all individuals who are issued CLPs or CDLs
under the terms and conditions of this waiver, on a monthly basis. The
SDLA must comply with all other requirements of parts 383.71 and
383.73.
    This waiver is applicable February 20, 2018 through May 21, 2018.

Safety Considerations

    Considering the limited period of this waiver, the fact that it
does not alter any of the knowledge and skills testing requirements for
obtaining a CDL, and the conditions set forth above, the Agency has
determined that the waiver is likely achieve a level of safety
equivalent to, or greater than, the level that would be achieved by
complying with the current regulations.

    Issued on: February 9, 2018.
Cathy F. Gautreaux,
Deputy Administrator.
[FR Doc. 2018-03362 Filed 2-16-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: March 19, 2008 (Volume 73, Number 54)]
[Rules and Regulations]
[Page 14713-14714]
[DOCID:fr19mr08-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0876; FRL-8344-1]

Spinetoram; Pesticide Tolerance; Technical Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; technical correction.

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SUMMARY: EPA issued a final rule in the Federal Register of October 10,
2007, concerning the establishment of a tolerance for the combined
residues of the insecticide spinetoram. This document is being issued
to correct a technical error, specifically, the omission of the
complete tolerance expression under Unit V. and in the regulatory text
section of the final rule.

DATES: This final rule is effective March 19, 2008.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0876. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bonaventure Akinlosotu, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    The Agency included in the final rule a list of those who may be
potentially affected by this action. If you have questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr.

II. What Does this Correction Do?

    The final rule, identified as FR Doc. E7-19947 that published in
the Federal Register of October 10, 2007 (72 FR 57492) (FRL-8149-9) is
corrected to fix a technical error, specifically, the omission of the
complete tolerance expression for the combined residues of the
insecticide spinetoram under Unit V. (page 57498, second column) and in
the regulatory text section (page 57499, first column) of the final
rule.

    Unit V. Conclusion, on page 57498, second column, is corrected to
read as follows:

    ``Therefore, the tolerance is established for the combined
residues of the insecticide spinetoram, expressed as a combination
of XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-
[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,4,5,5a,5b,

6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-,
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-
2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-
dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-
6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-
di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-
dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-
methyltetrahydro-2H-pyran-3-yl(methyl)formamide.''

III. Why is this Correction Issued as a Final Rule?

    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(3)(B), provides that, when an Agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the Agency may issue a final rule without
providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making this technical
correction final without prior proposal and opportunity for comment,
because this final rule corrects a technical error and does not
otherwise change the original requirements of the final rule. EPA finds
that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

IV. Do Any of the Statutory and Executive Order Reviews Apply to this
Action?

    This final rule corrects a technical error and does not otherwise
change the requirements in the final rule. As a technical correction,
this action is not subject to the statutory and Executive Order review
requirements. For information about the statutory and Executive Order
review requirements as they related to the final rule, see Unit VI. in
the Federal Register of October 10, 2007.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 4, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is corrected as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.635, the introductory text for paragraph (a) is revised
to read as follows:

Sec.  180.635  Spinetoram; tolerances for residues.

    (a) General. Tolerances are established for the combined residues
of the insecticide spinetoram, expressed as a combination of XDE-175-J:
1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-
ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-,
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-
L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide, in or on the following raw agricultural
commodities:
* * * * *

[FR Doc. E8-5402 Filed 3-18-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25786]
[DOCID:fr07my08-129]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension:
    Rule 102; OMB Control No. 3235-0467; SEC File No. 270-409.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the existing
collection of information provided for in the following rule: Rule 102
of Regulation M (17 CFR 242.102).
    Rule 102 prohibits distribution participants, issuers, and selling
security holders from purchasing activities at specified times during a
distribution of securities. Persons otherwise covered by these rules
may seek to use several applicable exceptions such as an exclusion for
actively traded reference securities and the maintenance of policies
regarding information barriers between their affiliates.
    There are approximately 945 respondents per year that require an
aggregate total of 1845 hours to comply with this rule. Each respondent
makes an estimated 1 annual response. Each response takes approximately
1.95 hours to complete. Thus, the total compliance burden per year is
1845 burden hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to: Alexander--
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted within 30
days of this notice.

    Dated: April 30, 2008.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-10044 Filed 5-6-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14874-14875]
[FR Doc No: 2016-06165]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4259-DR; Docket ID FEMA-2016-0001]

Georgia; 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 Georgia (FEMA-4259-DR), dated February 26,
2016, and related determinations.

DATES: Effective Date: February 26, 2016.

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 February 26, 2016, 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 Georgia resulting from severe storms and flooding during the
period of December 22, 2015 to January 13, 2016, 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 Georgia.
    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
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    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, Rosalyn L. Cole, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Georgia have been designated as
adversely affected by this major disaster:

    Baker, Carroll, Chattahoochee, Crawford, Dade, Decatur, Douglas,
Fannin, Fayette, Gilmer, Greene, Haralson, Harris, Jeff Davis,
Lamar, Macon, Marion, Meriwether, Montgomery, Morgan, Muscogee,
Newton, Oglethorpe, Pickens, Stewart, Talbot, Taliaferro, Taylor,
Towns, Troup, Upson, Webster, and Wilkes Counties for Public
Assistance.
    All areas within the State of Georgia 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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-06165 Filed 3-17-16; 8:45 am]
 BILLING CODE 9111-23-P