[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7194-7195]
[FR Doc No: 2018-03402]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-XXXX]

Statement of Organization, Functions, and Delegations of
Authority

AGENCY: Office of Regulatory Affairs, Office of Global Regulatory
Operations and Policy, Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of Global
Regulatory Operations and Policy, Office of Regulatory Affairs (ORA),
Office of Regulatory Science (ORS), and all ORA Laboratories have
modified the structure. This new organizational structure was approved
by the Secretary of Health and Human Services and effective on June 6,
2016.

FOR FURTHER INFORMATION CONTACT: Paul Norris, DVM, MPA, Director,
Office of Regulatory Science, Office of Regulatory Affairs, Office of
Global Regulatory Operations and Policy, Food and Drug Administration,
NCTR-50 Room 404, Jefferson, Arkansas 72079, Phone:<PHONE_NUMBER>.

I. Summary

    Part D, Chapter D-B (Food and Drug Administration), the Statement
of Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services 35 FR 3685, dated February 25,
1970; 60 FR 56605, dated November 9, 1995; 64 FR 36361, dated July 6,
1999; 72 FR 50112, dated August 30, 2007; 74 FR 41713, dated August 18,
2009; and 76 FR 45270, dated July 28, 2011, is amended to reflect the
reorganization of the Office of Regulatory Affairs and the Office of
Regulatory Science (ORS), and all ORA Laboratories in this
consolidation.
    This organization expands current activities in the Office of
Regulatory Science and ORA's Laboratories in support of the Agency's
Program Alignment Initiative. One of the key elements outlined in the
initiative is to transition to distinct commodity-based and vertically
integrated regulatory programs with well-defined leads, promoting
coherent policy and strategic development. This transforms the
regionally organized laboratory system into a true national resource
with enhanced ability to meet its public health mission to provide
diverse scientific expertise, leadership, and responsive quality
analytical services to safeguard public health in a global environment
and foster continued flexibility across its functions and programs. It
also centralizes and streamlines laboratory operations, scientific
research, and support functions into one Office of Regulatory Science.
Operationally this facilitates a more efficient and strategic
deployment of these resources during public health emergencies and food
borne outbreaks. Centralizing the laboratory system greatly enhances
command and control of laboratory functions.
    The Food and Drug Administration, Office of Global Regulatory
Operations and Policy, Office of Regulatory Affairs (ORA), Office of
Regulatory Science (ORS) has been restructured as follows:

    DLLRK. ORGANIZATION. The Office of Regulatory Science is headed
by the Director, Office of Regulatory Science and includes the
following organizational units:

Office of Regulatory Science (DLLRK)
Automated Laboratory Management Staff (DLLRK1)
Safety and Risk Management Staff (DLLRK2)
Office of Research Coordination and Evaluation (DLLRKA)
Scientific Research Staff (DLLRKA1)
Evaluation Staff (DLLRKA2)
Office of Medical Products, Tobacco, and Specialty Laboratory
Operations (DLLRKB)
Medical Products and Tobacco Scientific Staff (DLLRKB1)
Forensic Chemistry Center (DLLRKBA)
Inorganic Branch (DLLRKBA1)
Organic Branch (DLLRKBA2)
Winchester Engineering and Analytical Center (DLLRKBB)
Analytical Branch (DLLRKBB1)
Engineering Branch (DLLRKBB2)
Detroit Laboratory (DLLRKBC)
Northeast Medical Products Laboratory (DLLRKBD)
Pacific Southwest Medical Products Laboratory (DLLRKBE)
Philadelphia Laboratory (DLLRKBF)
San Juan Laboratory (DLLRKBG)
Southeast Tobacco Laboratory (DLLRKBH)
Office of Food and Feed Laboratory Operations (DLLRKC)
Food and Feed Scientific Staff (DLLRKC1)
Arkansas Laboratory (DLLRKCA)
Chemistry Branch I (DLLRKCA1)
Chemistry Branch II (DLLRKCA2)
Microbiology Branch (DLLRKCA3)
Denver Laboratory (DLLRKCB)
Chemistry Branch (DLLRKCB1)
Microbiology Branch (DLLRKCB2)
Kansas City Laboratory (DLLRKCC)
Chemistry Branch I (DLLRKCC1)
Chemistry Branch II (DLLRKCC2)
Northeast Food and Feed Laboratory (DLLRKCD)
Chemistry Branch I (DLLRKCD1)
Chemistry Branch II (DLLRKCD2)
Microbiology Sciences Branch (DLLRKCD3)
Pacific Northwest Laboratory (DLLRKCE)
Chemistry Branch (DLLRKCE1)
Microbiology Branch (DLLRKCE2)
Applied Technology Branch (DLLRKCE3)
San Francisco Laboratory (DLLRKCF)
Chemistry Branch (DLLRKCF1)
Microbiology Branch (DLLRKCF2)
Southeast Food and Feed Laboratory (DLLRKCG)
Microbiology Branch (DLLRKCG1)
Nutrient Analysis Branch (DLLRKCG2)
Chemistry Branch (DLLRKCG3)
Pacific Southwest Food and Feed Laboratory (DLLRKCH)
Chemistry Branch (DLLRKCH1)
Microbiology Branch (DLLRKCH2)

II. Delegations of Authority

    Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, all delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    Persons interested in seeing the complete Staff Manual Guide can
find it on FDA's website at: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

    Dated: December 21, 2017.
Eric D. Hargan
Acting Secretary of Health and Human Services.
[FR Doc. 2018-03402 Filed 2-16-18; 8:45 am]
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[Federal Register: June 5, 2007 (Volume 72, Number 107)]
[Notices]
[Page 31069]
[DOCID:fr05jn07-42]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R01-OAR-2007-0373; A-1-FRL-8321-6]

Adequacy Status of the Submitted 2009 Early Progress Direct
PM2.5 and NOX Motor Vehicle Emission Budgets for
Transportation Conformity Purposes; Connecticut; New York-Northern New
Jersey-Long Island, NY-NJ-CT PM2.5 Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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SUMMARY: In this notice, EPA is notifying the public that EPA has found
that the 2009 motor vehicle emissions budgets in the April 17, 2007
Connecticut State Implementation Plan (SIP) revision are adequate for
transportation conformity purposes. The submittal included MOBILE6.2
motor vehicle emissions budgets for 2009 for the Connecticut portion of
the New York-Northern New Jersey-Long Island, NY-NJ-CT PM2.5
Area. On March 2, 1999, the D.C. Circuit Court ruled that budgets in
submitted SIPs cannot be used for conformity determinations until EPA
has affirmatively found them adequate. As a result of our finding, the
State of Connecticut can use the MOBILE6.2 motor vehicle emissions
budgets from the submitted plan for future conformity determinations
for the Connecticut portion of the New York-Northern New Jersey-Long
Island, NY-NJ-CT PM2.5 area.

DATES: These motor vehicle emissions budgets are effective June 20,
2007.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Environmental
Scientist, Air Quality Planning Unit, U.S. Environmental Protection
Agency, EPA New England Regional Office, One Congress Street, Suite
1100 (CAQ), Boston, MA 02114-2023,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us'' or ``our'' is used, we mean EPA.
    Today's notice is simply an announcement of a finding that we have
already made. EPA New England sent a letter to Connecticut Department
of Environmental Protection on May 24, 2007, stating that the 2009
MOBILE6.2 motor vehicle emissions budgets in the April 17, 2007 State
Implementation Plans (SIPs) are adequate for transportation conformity
purposes. This finding will also be announced on EPA's conformity Web
site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm,

(once there, click on ``What SIP submissions has EPA already found
adequate or inadequate?''). The adequate motor vehicle emissions
budgets (MVEBs) are provided in the following table:

                Adequate Motor Vehicle Emissions Budgets
------------------------------------------------------------------------
                                       Direct PM2.5      NOX  (tons per
                                     (tons per year)         year)
------------------------------------------------------------------------
Year 2009 MVEBs for the                           360             18,279
 Connecticut portion of the New
 York-Northern New Jersey-Long
 Island, NY-NJ-CT PM2.5 Area......
------------------------------------------------------------------------

    Transportation conformity is required by section 176(c) of the
Clean Air Act. EPA's conformity rule requires that transportation
plans, programs, and projects conform to state air quality
implementation plans and establishes the criteria and procedures for
determining whether or not they do. Conformity to a SIP means that
transportation activities will not produce new air quality violations,
worsen existing violations, or delay timely attainment of the national
ambient air quality standards.
    The criteria by which we determine whether a SIP's motor vehicle
emission budgets are adequate for conformity purposes are outlined in
40 CFR 93.118(e)(4). Please note that an adequacy review is separate
from EPA's completeness review, and it also should not be used to
prejudge EPA's ultimate approval of the SIP. Even if we find a budget
adequate, the SIP could later be disapproved.
    We have described our process for determining the adequacy of
submitted SIP budgets in a May 14, 1999 memorandum entitled
``Conformity Guidance on Implementation of March 2, 1999 Conformity
Court Decision.'' Additional guidance on EPA's adequacy process was
published in a July 1, 2004 Federal Register final rulemaking,
``Transportation Conformity Rule Amendments for the New 8-hour Ozone
and PM2.5 National Ambient Air Quality Standards and
Miscellaneous Revisions for Existing Areas; Transportation Conformity
Rule Amendments: Response to Court Decision and Additional Rule
Changes'' (69 FR 40004). We followed this guidance in making our
adequacy determination.

    Authority: 42 U.S.C. 7401-7671q.

    Dated: May 29, 2007.
Robert W. Varney,
Regional Administrator, EPA New England.
 [FR Doc. E7-10770 Filed 6-4-07; 8:45 am]

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[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67465-67466]
[FR Doc No: 2011-28224]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on Public Advisory Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on certain device panels of
the Medical Devices Advisory Committee (MDAC) in the Center for Devices
and Radiological Health (CDRH) notify FDA in writing. FDA is also
requesting nominations for a nonvoting industry representative(s) to
serve on certain device panels of the MDAC in the CDRH. A nominee may
either be self-nominated or nominated by an organization to serve as a
nonvoting industry representative. Nominations will be accepted for
current vacancies effective with this notice.

DATES: Any industry organizations interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by December
1, 2011, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by December
1, 2011.

ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret Ames (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5234, Silver Spring, MD 20993,<PHONE_NUMBER>, Fax:
(301) 847-8505, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 520(f)(3) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(f)(3)), as amended by
the Medical Device Amendments of 1976, provides that each medical
device panel include one nonvoting member to represent the interests of
the medical device

manufacturing industry. The Agency is requesting nominations for
nonvoting industry representatives to certain panels identified in the
following paragraphs.

I. Functions of MDAC

    (1) Review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation, (2) advise the Commissioner of Food and Drugs (the
Commissioner) regarding recommended classification or reclassification
of these devices into one of three regulatory categories, (3) advise on
any possible risks to health associated with the use of devices, (4)
advise on formulation of product development protocols, (5) review
premarket approval applications for medical devices, (6) review
guidelines and guidance documents, (7) recommend exemption to certain
devices from the application of portions of the FD&C Act, (8) advise on
the necessity to ban a device, (9) respond to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices, and (10) make
recommendations on the quality in the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.

A. Clinical Chemistry and Clinical Toxicology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational in vitro devices for use in clinical
laboratory medicine, including clinical toxicology, clinical chemistry,
endocrinology, and oncology, and makes appropriate recommendations to
the Commissioner.

B. Ear, Nose, and Throat Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness
of market and investigational ear, nose, and throat devices, and makes
appropriate recommendations to the Commissioner.

C. Medical Devices Dispute Resolution Panel

    Provides advice to the Center Director 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
Agency decisions or actions.

D. Microbiology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational in vitro devices for use in clinical
laboratory medicine, including microbiology, virology, and infectious
disease, and makes appropriate recommendations to the Commissioner.

E. Molecular and Clinical Genetics Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational in vitro devices for use in clinical
laboratory medicine, including clinical and molecular genetics, and
makes appropriate recommendations to the Commissioner.

F. Orthopaedic and Rehabilitation Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational orthopaedic and rehabilitation devices,
and makes appropriate recommendations to the Commissioner.

G. Radiological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational diagnostic or therapeutic radiological
and nuclear medicine devices and makes appropriate recommendations to
the Commissioner.

II. Qualifications

    Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers or have similar
appropriate ties to industry.

III. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular device panel. The interested organizations
are not bound by the list of nominees in selecting a candidate.
However, if no individual is selected within the 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.

IV. Application Procedure

    Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the panel. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
    FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees and, therefore,
encourages nominations for appropriately qualified candidates from
these groups. Specifically, in this document, nominations for nonvoting
representatives of industry interests are encouraged from the device
manufacturing industry.
    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: October 26, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-28224 Filed 10-31-11; 8:45 am]
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