[Federal Register: July 23, 2008 (Volume 73, Number 142)]
[Rules and Regulations]
[Page 42676-42679]
[DOCID:fr23jy08-3]

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DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30619; Amdt. No. 3279]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under

instrument flight rules at the affected airports.

DATES: This rule is effective July 23, 2008. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of July 23, 2008.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
Information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under DOT
Regulatory Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on July 11, 2008.
James J. Ballough,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, Part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, and
97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

. . . Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
      FDC date            State            City                 Airport            FDC No.          Subject
----------------------------------------------------------------------------------------------------------------
07/02/08............  CA..........  Salinas...........  Salinas Muni...........       8/4752  ILS OR LOC Rwy 31,
                                                                                Amdt 5B.
06/27/08............  UT..........  Salt Lake City....  Salt Lake City Intl....       8/4753  RNAV (GPS) Rwy 17,
                                                                                Orig.
06/27/08............  UT..........  Salt Lake City....  Salt Lake City Intl....       8/4754  VOR/DME Rwy 34R,
                                                                                Amdt 9.
06/27/08............  MA..........  Hyannis...........  Barnstable Muni-              8/4859  Takeoff Minimums
                                                         Boardman/Polando Field.               and (Obstacle)
                                                                                DP, Amdt 3.
06/27/08............  GA..........  Atlanta...........  Hartsfield-Jackson            8/4864  VOR Rwy 27L, Amdt
                                                         Atlanta Intl.                         4B.
06/27/08............  MA..........  Hyannis...........  Barnstable Muni-              8/4865  VOR Rwy 6, Amdt 9.
                                                         Boardman/Polando Field.
06/30/08............  GA..........  Dalton............  Dalton Muni............       8/5046  RNAV (GPS) Rwy 14,
                                                                                Orig.
06/30/08............  GA..........  Dalton............  Dalton Muni............       8/5047  ILS OR LOC Rwy 14,
                                                                                Orig.
06/30/08............  VA..........  Danville..........  Danville Regional......       8/5129  VOR Rwy 2, Amdt
                                                                                13.
06/30/08............  SC..........  Myrtle Beach......  Myrtle Beach Intl......       8/5130  ILS OR LOC Rwy 18,
                                                                                Amdt 1G.
06/30/08............  PA..........  Johnstown.........  John Murtha Johnstown-        8/5138  VOR/DME Rwy 23,
                                                         Cambria County.                       Amdt 1.
06/30/08............  PA..........  Johnstown.........  John Murtha Johnstown-        8/5139  VOR Rwy 23, Amdt
                                                         Cambria County.                       7.
07/01/08............  WV..........  Clarksburg........  North Central West            8/5239  ILS Rwy 21, Amdt
                                                         Virginia.                             1.
07/01/08............  FL..........  Titusville........  Arthur Dunn Airpark....       8/5288  Takeoff Minimums
                                                                                and (Obstacle)
                                                                                DP, Amdt 1.
07/01/08............  AK..........  Egegik............  Egegik.................       8/5335  RNAV (GPS) Rwy 12,
                                                                                Amdt 1.
07/01/08............  AK..........  Egegik............  Egegik.................       8/5336  RNAV (GPS) Rwy 30,
                                                                                Amdt 1.
07/01/08............  OR..........  Redmond...........  Roberts Field..........       8/5340  RNAV (GPS) Rwy 28,
                                                                                Orig-A.
07/01/08............  OR..........  Medford...........  Rogue Valley Intl......       8/5343  VOR/DME Rwy 14,
                                                                                Amdt 5.
07/01/08............  OR..........  Medford...........  Rogue Valley Intl......       8/5344  VOR/DME C, Amdt 3.
07/01/08............  OR..........  Medford...........  Rogue Valley Intl......       8/5345  LOC/DME BC B, Amdt
                                                                                6A.
07/01/08............  OR..........  Medford...........  Rogue Valley Intl......       8/5348  RNAV (GPS) D, Orig-
                                                                                A.
07/01/08............  MI..........  Saginaw...........  Saginaw County H.W.           8/5479  RNAV (GPS) Rwy 9,
                                                         Browne.                               Orig.
07/02/08............  GA..........  Augusta...........  Daniel Field...........       8/5532  NDB OR GPS Rwy 11,
                                                                                Amdt 3.
07/02/08............  CA..........  Petaluma..........  Petaluma Muni..........       8/5572  VOR/DME Rwy 29,
                                                                                Orig.
07/09/08............  AK..........  Anaktuvuk Pass....  Anaktuvuk Pass.........       8/5573  RNAV (GPS) A,
                                                                                Orig.
07/09/08............  AK..........  St Michael........  St Michael.............       8/5574  RNAV (GPS) Rwy 2,
                                                                                Orig.
07/02/08............  CA..........  San Diego.........  San Diego Intl.........       8/5575  ILS Rwy 9, Amdt 1.
07/02/08............  CA..........  San Diego.........  San Diego Intl.........       8/5576  RNAV (GPS) Rwy 9,
                                                                                Orig.
07/09/08............  AK..........  St George.........  St George..............       8/5586  RNAV (GPS) B,
                                                                                Orig.
07/09/08............  AK..........  St George.........  St George..............       8/5587  RNAV (GPS) D,
                                                                                Orig.
07/03/08............  MA..........  New Bedford.......  New Bedford Regional...       8/5876  ILS Rwy 5, Amdt
                                                                                25.
07/03/08............  CA..........  Ukiah.............  Ukiah Muni.............       8/5916  VOR/DME RNAV OR
                                                                                GPS B, Amdt 4.
07/03/08............  CA..........  Ukiah.............  Ukiah Muni.............       8/5917  VOR OR GPS A, Amdt
                                                                                3.
07/03/08............  CA..........  Ukiah.............  Ukiah Muni.............       8/5918  LOC Rwy 15, Amdt
                                                                                5A.
07/09/08............  AK..........  King Cove.........  King Cove..............       8/5921  RNAV (GPS) A, Orig-
                                                                                A.
07/07/08............  AR..........  Little Rock.......  Adams Field............       8/6150  VOR A, Orig-A.
07/07/08............  AR..........  Little Rock.......  Adams Field............       8/6151  ILS OR LOC Rwy 4L,
                                                                                Amdt 25B.
07/07/08............  WI..........  Oshkosh...........  Wittman Rgnl...........       8/6190  VOR Rwy 9, Amdt 9.
07/07/08............  WI..........  Oshkosh...........  Wittman Rgnl...........       8/6193  RNAV (GPS) Rwy 9,
                                                                                Orig.
07/07/08............  CA..........  Sacramento........  Sacramento Intl........       8/6194  ILS Rwy 16L, Amdt
                                                                                1.
07/07/08............  CA..........  Sacramento........  Sacramento Intl........       8/6195  RNAV (GPS) Rwy
                                                                                34R, Orig-B.
07/07/08............  CA..........  Sacramento........  Sacramento Intl........       8/6196  RNAV (GPS) Rwy
                                                                                16L, Orig-B.
07/07/08............  CA..........  Sacramento........  Sacramento Intl........       8/6197  RNAV (GPS) Rwy
                                                                                16R, Orig-C.

07/07/08............  CA..........  Sacramento........  Sacramento Intl........       8/6201  ILS Rwy 16R, Amdt
                                                                                14A...ILS Rwy 16R
                                                                                (CAT II), Amdt
                                                                                14A...ILS Rwy 16R
                                                                                (CAT III), Amdt
                                                                                14A.
07/07/08............  NE..........  Grand Island......  Central Nebraska              8/6211  ILS OR LOC Rwy 35,
                                                         Regional.                             Amdt 9C.
07/07/08............  CA..........  Livermore.........  Livermore Muni.........       8/6221  GPS Rwy 25R, Orig-
                                                                                A.
07/02/08............  CO..........  Denver............  Centennial.............       8/6226  NDB Rwy 35R, Amdt
                                                                                10A.
07/02/08............  CO..........  Denver............  Centennial.............       8/6227  ILS Rwy 35R, Amdt
                                                                                8A.
07/01/08............  DE..........  Wilmington........  New Castle.............       8/6228  ILS OR LOC Rwy 1,
                                                                                Amdt 21.
07/07/08............  NV..........  Reno..............  Reno/Stead.............       8/6231  Take-Off Minimums
                                                                                And (Obstacle)
                                                                                Departure
                                                                                Procedures, Amdt
                                                                                3.
07/09/08............  AK..........  Anchorage.........  Ted Stevens Anchorage         8/6232  ILS OR LOC/DME Rwy
                                                         Intl.                                 7R, Orig.
07/09/08............  AK..........  Anchorage.........  Ted Stevens Anchorage         8/6233  ILS Rwy 14, Amdt
                                                         Intl.                                 4.
07/09/08............  AK..........  Anchorage.........  Ted Stevens Anchorage         8/6234  RNAV (GPS) Rwy 14,
                                                         Intl.                                 Amdt 1.
07/09/08............  AK..........  Anchorage.........  Ted Stevens Anchorage         8/6235  ILS OR LOC/DME Rwy
                                                         Intl.                                 7L, Orig.
07/09/08............  AK..........  Anchorage.........  Ted Stevens Anchorage         8/6236  VOR Rwy 7R, Amdt
                                                         Intl.                                 13.
07/03/08............  AL..........  Headland..........  Headland Muni..........       8/6282  RNAV (GPS) Rwy 27,
                                                                                Orig.
07/03/08............  IA..........  Ames..............  Ames Muni..............       8/6314  RNAV (GPS) Rwy 13,
                                                                                Orig-A.
07/03/08............  TX..........  Houston...........  George Bush                   8/6315  ILS OR LOC Rwy 9,
                                                         Intercontinental/                     Amdt 7A.
                                                         Houston.
07/03/08............  WV..........  Summersville......  Summersville...........       8/6323  GPS Rwy 4, Amdt 2.
07/03/08............  NV..........  Las Vegas.........  Mc Carran Intl.........       8/6362  ILS Rwy 25L, Amdt
                                                                                3A.
07/03/08............  NV..........  Las Vegas.........  Mc Carran Intl.........       8/6363  ILS OR LOC Rwy
                                                                                25R, Amdt 16H.
07/03/08............  LA..........  Shreveport........  Shreveport Downtown....       8/6536  RNAV (GPS) Rwy 14,
                                                                                Orig.
07/07/08............  KS..........  Wellington........  Wellington Muni........       8/6699  VOR/DME Rwy 17,
                                                                                Amdt 2.
05/31/08............  MI..........  Saginaw...........  Saginaw County H.W.           8/9533  RNAV (GPS) Rwy 9,
                                                         Browne.                               Orig. This Notam
                                                                                Published In Tl08-
                                                                                15 Is Hereby
                                                                                Rescinded In Its'
                                                                                Entirety.
05/31/08............  NY..........  Albany............  Albany Intl............       8/9706  RNAV (GPS) Rwy 19,
                                                                                Orig. This Notam
                                                                                Published In Tl08-
                                                                                15 Is Hereby
                                                                                Rescinded In Its
                                                                                Entirety.
----------------------------------------------------------------------------------------------------------------

 [FR Doc. E8-16528 Filed 7-22-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9571-9575]
[DOCID:fr21fe08-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0082]

Animal Drug User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the agency) is
publishing proposed recommendations for the reauthorization of the
Animal Drug User Fee Act of 2003 (ADUFA) for fiscal years (FY) 2009 to
2013. These proposed recommendations were developed after a public
meeting with stakeholders and discussions with regulated industry.
ADUFA, enacted November 18, 2003, directs FDA to publish these proposed
recommendations in the Federal Register; hold a meeting at which the
public may present its views on such recommendations; and provide a
period of 30 days for the public to provide written comments on such
recommendations.
    Dates and Time: The public meeting will be held on March 11, 2008,
from 1 p.m. to 3:30 p.m.
    Location: The public meeting will be held at 7519 Standish Pl.,
third floor, rm. A, Rockville, MD 20855. There is parking near the
building. Photo identification is required to clear building security.
    Contact Person: Roxanne Schweitzer, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7529 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
    Registration: To ensure there is sufficient room we ask that you
pre-register. Furthermore, to assist us in scheduling, we ask that you
notify us through the registration process if you wish to make a public
comment at the meeting. To register, please send an electronic mail
message to<EMAIL_ADDRESS>by March 4, 2008. Your e-mail
should include the following information: Name, Company, Company
Address, Company Telephone Number, and E-mail Address. You will receive
a confirmation within 2 business days.
    FDA also will accept walk-in registration at the meeting site, but
space is limited, and the agency will close registration when maximum
seating capacity (approximately 500) is reached. FDA will try to
accommodate all persons who wish to make a public comment at the
meeting, including those who register at the meeting site, however, the
time allotted for public comments may depend on the number of persons
who wish to speak.
    Additionally, please notify FDA (see Contact Person) if you need
any special accommodations (such as wheelchair access or a sign
language interpreter) at least 7 days in advance.
    Comments: To ensure consideration of your comments regarding these
proposed recommendations, you should

submit comments by April 14, 2008. Interested persons may submit
written or electronic comments to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
 Submit a single copy of electronic comments or two

paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Section 4 of ADUFA, enacted in 2003 (Public Law 108-130, November
18, 2003), authorized FDA to collect user fees from regulated industry
that were to be dedicated to expediting the review of animal drug
applications in accordance with certain performance goals identified in
letters dated November 13, 2003, from the Secretary of Health and Human
Services to the Chairman and Ranking Minority Member of the Energy and
Commerce Committee of the House of Representatives and the Chairman and
Ranking Minority Member of the Health, Education, Labor and Pensions
Committee of the Senate.
    Before ADUFA, FDA's animal drug review process was unpredictable
and slow. Since the implementation of ADUFA there has been a
significant improvement in FDA funding for the process for review of
new animal drug applications (NADA), including significant investments
in infrastructure and support. ADUFA has enabled FDA to increase the
staff dedicated to the process of reviewing animal drug applications
since 2003 by about 30 percent. As a result, the process for review of
NADAs has become more predictable and faster.
    Under ADUFA, the industry provides user fees that are available to
FDA, in addition to appropriated funds, to spend on the animal drug
review process. Moreover, FDA authority to collect user fees is
``triggered'' only when a base amount of appropriated funds, adjusted
for inflation, is spent.
    As part of ADUFA, FDA established review performance goals that
have been phased in over a 5 year period. These performance goals run
from FY 2004 through FY 2008 and are intended to achieve progressive,
yearly improvements in the time for review of animal drug applications.
FDA agreed to review and act on submissions within shorter periods of
time each fiscal year. With the fifth and final year of ADUFA ending on
September 30, 2008, FDA has agreed to review and act on 90 percent of
the following submission types within specified times:
     Animal drug applications and reactivations of such
applications within 180 days after submission date.
     Non-manufacturing supplemental animal drug applications
(that is, supplemental animal drug applications for which safety or
effectiveness data are required) and reactivations of such supplemental
applications within 180 days after submission date.
     Manufacturing supplemental animal drug applications and
reactivations of such supplemental applications within 120 days after
submission date.
     Investigational animal drug study submissions within 180
days after submission date.
     Investigational animal drug submissions consisting of
protocols, that FDA and the sponsor consider to be an essential part of
making the decision to approve or not approve an animal drug
application or supplemental animal drug application, without
substantial data, within 60 days after submission date.
     Administrative animal drug applications submitted after
all scientific decisions have been made in the investigational animal
drug process (that is, prior to submission of the animal drug
application) within 60 days after submission date.
    We began public consultation on ADUFA reauthorization with a public
meeting held on April 24, 2007. The meeting included presentations by
FDA and four speakers from the public. FDA presented information on
ADUFA's successful performance and financial outcomes. The public
participants represented different stakeholder groups, including
consumer groups and regulated industry. The stakeholders were asked to
respond to the following questions: (1) What is your assessment of the
overall performance of the ADUFA program thus far and (2) What
suggestions or changes would you make relative to the reauthorization
of ADUFA? There was general agreement among the responding stakeholders
that ADUFA should be reauthorized. In preparing proposed
recommendations for ADUFA reauthorization (ADUFA II), FDA has also
conducted technical discussions with regulated industry.
    Congress also directed FDA to: (1) Publish in the Federal Register
the proposed recommendations developed through this process after
negotiations with the regulated industry, (2) present the proposed
recommendations to the congressional committees specified in the
statute, (3) hold a public meeting at which the public can present its
views on the proposed recommendations, and (4) provide a period of 30
days for the public to provide written comment on the proposed
recommendations.
    We have now concluded discussions with industry and other
stakeholders regarding reauthorization of ADUFA. The purpose of this
document is to publish the recommendations FDA intends to propose to
Congress and announce the dates for the upcoming public meeting and
written comment period. After the public meeting and the close of the
30-day comment period, FDA plans to undertake a careful review of all
public comments on these proposed recommendations.

II. What FDA is Proposing to Recommend for ADUFA II

    For ADUFA II, as described in the following paragraphs, FDA plans
to carry forward the performance goals from ADUFA and to propose
additional goals related to proposed enhancements to the program.
Proposed recommendations fall into three categories:
    A. Proposals to Ensure Sound Financial Footing for the Animal Drug
Review Program
    B. Proposals to Enhance the Process for Review of Animal Drug
Applications and
    C. Improving the Information Technology (IT) Infrastructure for
Animal Drug Review

A. Proposed Recommendations to Ensure Sound Financial Footing

    Although user fees have provided substantial resources to FDA since
the beginning of the program, user fees have not kept up with the
increasing costs of the program associated with inflation in pay and
benefit costs to the agency, and rent and rent-related costs. FDA has
experienced an increase in costs of pay and benefits averaging 5.9
percent per year over the most recent 5 years. Non-salary costs,
including the costs of rent and contract support, have also increased
at the same rate. FDA is proposing changes to the financial provisions
of ADUFA to address these shortcomings and place the program on sound
financial footing so FDA can

continue with the program and enhance it.
1. The Proposals Set the Total Fee Revenue Amounts in Section 740(b) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379j-
12(b)) to Assure That the Amounts Grow Sufficiently Each Year to Cover
FDA's Anticipated Change in Costs Each Year
    Based on an analysis of FDA's recent costs history and anticipated
costs over the next 5 years, FDA expects the trend of increasing costs
to continue. FDA's proposed recommendation to Congress, after
consultation with regulated industry, is that the total fee revenue
estimate for each of the 5 fiscal years of ADUFA II be the amounts set
out in table 1 of this document.

                                         Table 1.-- ADUFA II Fee Revenue Targets for Each Year Beginning FY 2009
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Fiscal Year                     2009                2010                 2011               2012               2013              Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Revenue Target                       $15,260,000           $17,280,000        $19,448,000        $21,768,000        $24,244,000        $98,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    With this level of proposed funding, FDA can have confidence that
it will have a stable review workforce over the 5 years to be covered
by ADUFA II. That assurance of a stable animal drug review workforce
enables FDA to commit to a continuation of the FY 2008 performance
goals, and to some additional performance goals.
2. Proposed Elimination of the Inflation Adjustment Applied to User
Fees
    Because the proposed total fee revenue amounts already have the
costs of inflation built into them, there is no need for the inflation
adjustment that was applied to the total revenue amounts that were in
ADUFA. Accordingly, FDA proposes to eliminate the inflation adjustment
provisions for the fee revenue amounts.
3. Technical Changes to Increase Administrative Efficiency of the User
Fee Program
    FDA is proposing several technical changes to ADUFA to clarify the
original intent of several ADUFA definitions and to remove potential
ambiguity. FDA's analysis of the impact of these changes indicates that
they would be revenue-neutral and would have a minimal impact on
industry fee-payers. These technical proposals include the following:
     Change the date for the calculation of the inflationary
adjustment factor so it can be calculated before the President's budget
is sent to Congress;
     Amend the definition of ``animal drug sponsor'' to clarify
that it includes a holder of an approved application for an animal drug
that is not marketed but the application has not been withdrawn;
     Add the definition of ``person'' to include affiliates,
which continues the current interpretation of the act and parallels
recent changes made to Prescription Drug User Fee Act;
     Change the application fee rate for combination
applications subject to the criteria of section 512(d)(4) of act (21
U.S.C. 360b(d)(4)) (Animal Drug Availability Act combinations) to one-
half the full application fee rate;
     Delay offsets for collections in excess of appropriations
in any year to the final year of the ADUFA program and make offsetting
reductions only if cumulative fees collected over the first 4 years
exceed cumulative appropriations for fees over the same period; and
     Revise the authorization of appropriations in the act to
match the total fee revenue amounts being proposed.
4. Triggers
    ADUFA has three triggers. One is tied to appropriations for the
process for review of new animal drug applications and two are tied to
agency appropriations. FDA is proposing to leave the current triggers
unchanged through ADUFA II. The three triggers are as follows:
    (1) Fees may not be assessed for a FY beginning after FY 2003
unless appropriations for salaries and expenses of FDA for such FY
(excluding the amount of fees appropriated for such FY) are equal to or
greater than the amount of appropriations for the salaries and expenses
of FDA for FY 2003 (excluding the amount of fees appropriated for such
FY) multiplied by the adjustment factor applicable to the FY involved.
    (2) The fees authorized shall only be collected and available to
defray increases in the cost of the resources allocated for the process
for the review of animal drug applications (including increases in such
costs for an additional number of full-time equivalent positions in the
Department of Health and Human Services to be engaged in such process)
over such costs, excluding costs paid from fees collected for FY 2003
multiplied by the adjustment factor.
    (3) The fees authorized by this section shall be retained in each
FY in an amount not to exceed the amount specified in appropriation
acts, or otherwise made available for obligations for such FY.

B. Enhancing the Process for Premarket Review

    We are proposing changes to the performance goals that ADUFA
established to enhance the process for review of animal drug
applications. In addition to the performance goals established by ADUFA
for the review of administrative animal drug applications submitted
after all scientific decisions have been made in the investigational
animal drug process (that is, prior to submission of the animal drug
application) and the review of manufacturing supplemental animal drug
applications and reactivations of such supplemental applications, FDA
has agreed to revised performance goals for the following submission
types:
    (1) The agency will review and act on 90 percent of non-
administrative animal drug applications and reactivations of such
applications within:
     180 days after the submission date (Day 180) if the agency
determines that the application is complete or incomplete. An
application is incomplete if it would require substantial data or
information to enable the agency to complete a comprehensive review of
the application and reach a decision on the approvability of the
application; or
     220 days after the submission date if the agency
determines that the submission of additional non-substantial data or
information would likely complete the application and electronically
requests an end-review amendment

to the application on or before Day 180, but the sponsor fails to file
such amendment on or before Day 210. If a sponsor files an amendment
after Day 210, then the amendment is ineligible for consideration as an
end-review amendment, the extended performance goal (345 days) will not
apply, and a complete action letter will be issued by Day 220 for the
original application; or
     345 days after the submission date if the agency
electronically requests an end-review amendment to the application on
or before Day 180 and the sponsor files an end-review amendment on or
before Day 210.
    (2) The agency will review and act on 90 percent of non-
manufacturing supplemental animal drug applications (i.e., supplemental
animal drug applications for which safety or effectiveness data are
required) and reactivations of such supplemental applications within:
     180 days after the submission date (Day 180) if the agency
determines that the application is complete or incomplete. An
application is incomplete if it would require substantial data or
information to enable the agency to complete a comprehensive review of
the application and reach a decision on the approvability of the
application; or
     220 days after the submission date if the agency
determines that the submission of additional non-substantial data or
information would likely complete the application and electronically
requests an end-review amendment to the application on or before Day
180, but the sponsor fails to file such amendment on or before Day 210.
If a sponsor files an amendment after Day 210, then the amendment is
ineligible for consideration as an end-review amendment, the extended
performance goal (345 days) will not apply, and a complete action
letter will be issued by Day 220 for the original application; or
     345 days after the submission date if the agency
electronically requests an end-review amendment to the application on
or before Day 180 and the sponsor files an end-review amendment on or
before Day 210.
    (3) The agency will review and act on 90 percent of investigational
animal drug study submissions within:
     180 days after the submission date (Day 180) if the agency
determines that the submission is complete or incomplete. A submission
is incomplete if it would require substantial data or information to
enable the agency to complete a comprehensive review of the study
submission and reach a decision on the issue(s) presented in the
submission; or
     220 days after the submission date if the agency
determines that the submission of additional non-substantial data or
information would likely complete the submission and electronically
requests an end-review amendment to the submission on or before Day
180, but the sponsor fails to submit such amendment on or before Day
210. If a sponsor submits an amendment after Day 210, then the
amendment is ineligible for consideration as an end-review amendment,
the extended performance goal (270 days) will not apply, and a complete
action letter will be issued by Day 220 for the original submission; or
     270 days after the submission date if the agency
electronically requests an end-review amendment to the submission on or
before Day 180 and the sponsor submits an end-review amendment on or
before Day 210.
    (4) Review and act on 90 percent of investigational animal drug
submissions consisting of protocols without substantial data, that the
agency and the sponsor consider to be an essential part of the basis
for making the decision to approve or not approve an animal drug
application or supplemental animal drug application, within:
     60 days after the submission date (Day 60) if the agency
does not request an end-review amendment to the protocol and the agency
determines that the protocol is acceptable, the agency will notify the
sponsor of this decision electronically on or before Day 50, followed
by a complete action letter; or
     60 days after the submission date (Day 60) if the agency
does not request an end-review amendment to the protocol and the agency
determines that a protocol is not acceptable, the agency will notify
the sponsor of this decision electronically, providing preliminary
broad areas of protocol deficiency, on or before Day 50, with the
subsequently issued complete action letter providing the detailed
protocol assessment. The sponsor may contact the agency for a brief
clarification of these areas of deficiency prior to the issuance of the
complete action letter; or
     75 days after the submission date if the agency
electronically requests an end-review amendment to the protocol on or
before Day 50, but the sponsor fails to submit such amendment within 10
days of the amendment request date. If a sponsor files an amendment
more than 10 days after the amendment request date, then the amendment
is ineligible for consideration as an end-review amendment, the
extended performance goal (refer to the following paragraph) will not
apply, and a complete action letter will be issued by Day 75 for the
original submission; or
     The greater of 60 days after the original protocol is
received by the agency or 20 days after the amended protocol is
received by the agency if the agency electronically requests an end-
review amendment on or before Day 50 and the sponsor submits such
amendment within 10 days of the date the amendment is requested.
    (5) The following are additional efforts related to the performance
goals for all submission types being proposed for ADUFA II to enhance
the premarket review of animal drug applications:
     The agency and regulated industry agree to participate in
10 public workshops by the end of FY 2013 on mutually agreed-upon
topics;
     To improve the timeliness and predictability of foreign
preapproval inspections (PAIs), sponsors may voluntarily submit at the
beginning of the calendar year, a list of foreign manufacturing
facilities that are subjects of animal drug applications, supplemental
animal drug applications, or investigational animal drug submissions
and may be subject to foreign PAIs for the following fiscal year;
     If such a list is voluntarily submitted the sponsor should
submit a notification 30 days prior to submitting an animal drug
application, a supplemental animal drug application, or investigational
animal drug submission that informs the agency that the application
includes a foreign manufacturing facility; (should any changes to the
annual list occur after its submission to the agency, the sponsor may
provide the updated information to the agency);
     The agency and the regulated industry agree to explore and
discuss the applicable use of pharmacokinetic/pharmacodynamic data in
the development and evaluation of new animal drugs

submitted for approval;
     The agency and the regulated industry agree to explore
opportunities for exchange of information regarding the characteristics
of a new animal drug, and to identify safety and effectiveness issues
as early as possible in the drug development process; and
     The agency and regulated industry commit to work together
to explore shorter timeframes commensurate with the magnitude of
submitted pharmacokinetic/pharmacodynamic and other new animal drug
characteristic data/information.

C. Improving the Information Technology (IT) Infrastructure for Animal
Drug Review

    In the recommended IT performance goals for ADUFA II, FDA will
develop an electronic submission tool for industry submissions and
online review capability within 24 months of appropriated ADUFA funds
for FY 2009. The agency will consult with the sponsors in the
development of this tool.

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will FDA Use?

    Through this document, FDA is announcing the convening of a public
meeting to hear stakeholder views on the recommendations we propose to
provide to Congress on the reauthorization of ADUFA.
    FDA will conduct the meeting at 1 p.m. on March 11, 2008, at 7519
Standish Pl., third floor, rm. A, Rockville, MD 20855. In general, the
meeting format will include presentations by FDA and an open comment
period for the public. FDA will also give organizations and individuals
an opportunity to submit written comments to the docket after the
meeting.

B. Will Meeting Transcripts Be Available?

    FDA will prepare a meeting transcript and make it available on the
agency's Web site (http://www.fda.gov) after the meeting. FDA anticipates that

transcripts will be available approximately 30 business days after the
meeting.The transcript will also be available for public examination at
the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through
Friday.

    Dated: February 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3267 Filed 2-20-08; 8:45 am]

BILLING CODE 4160-01-S


FDA personnel for Dockets Management Branch materials and to
copyrighted documents.
    6. Plans and conducts Agency wide analytical reviews and studies to
assess and management information and address concerns. Makes
recommendations and assists in the implementation of the
recommendations.
    Division of Freedom of Information:
    1. Serves as the Agency expert and focal point for headquarters and
field personnel in the development and implementation of effective
policies and procedures in accordance with the FOIA, the Privacy Act,
FDA regulations, and other relevant statutes. Establishes Agency-wide
policies and provides guidance and leadership for the FOIA and Privacy
Act programs. Serves as the Agency's official Call Center and Public
Liaison Office for FOIA matters.
    2. Receives, reviews, controls, coordinates and routes all FOI
requests to the proper action office; designs and implements control
mechanisms to assure FOI and Privacy Act inquiries are processed and
responded to within established timeframes.
    3. Receives and reviews all recommendations for denials submitted
by headquarters and field FOI officers. Analyzes the proposals and
evaluates the potential need for supplemental information and/or
changes in the recommendations, and coordinates with the submitting
office before issuance of a denial for a grant of access, expedited
processing, or fee waivers.
    4. Analyzes, compiles, and prepares reports on privacy and FOI
activities in the Agency for the annual reports to the Department and
for other reporting requirements.
    5. Maintains copies of Agency manuals, indexes, and other records
required to be on public display in the public reading room.
    FDA Biosciences Library:
    The FDA Biosciences Library is responsible for planning and
directing Agency library programs to set the direction, coordinate,
determine policy, and provide oversight for the provision of library
services and information, in a variety of formats and for a variety of
purposes to FDA and the public. The following are specific functions
within the Office:
    1. Provides research support to FDA through delivery of information
consulting and advisory services, literature searches, and document
delivery services in order for FDA to carry out its public health
mission.
    2. Collaborates with FDA researchers on research projects,
bibliographies, internal publication databases, copyright issues,
digitization and more, so FDA has the information it needs to meet its
scientific and regulatory mission.
    3. Plans, develops and conducts training sessions to teach
customers how to access and best utilize the online resources available
to them to enhance their research efforts.
    4. Stewards of a unique, valuable, extensive and specialized
collection of materials essential to FDA's scientific, legal,
administrative and regulatory staff. Collects, organizes, maintains and
preserves information resources, in multiple formats, in all areas of
FDA's research and products FDA regulates, including: Biologics, blood
products, cosmetics, devices, drugs, food processing and safety,
nutrition, pharmacy, pharmacology, radiology, tobacco, toxicology, and
veterinary medicine.
    5. Promotes and markets services and resources to customers.
Leverages FDA's resources and increases awareness of the library
services, staff expertise, and its valuable research collection.
Provides services and resources to Agency customers, other Federal
employees and the public on a limited basis.
    6. Selects, evaluates, acquires and/or develops, and provides
electronic access to scientific and technical databases, publications
and other media mechanisms in support of Agency-wide research needs.
    7. Partners with libraries and information centers, publishers,
consortia across the Federal government, health related associations,
and other organizations, to enhance resource sharing opportunities that
provide for cost savings, resource sharing, sharing of skills and
knowledge, benchmarking best practices, and collaboration on projects
that have a beneficial impact on the library and FDA's work.
    Public Services Branch:
    1. Maintains library operations and staffs the public information
desk, responding to requests for information from FDA and members of
the public.
    2. Provides information, information services and research support
to FDA through access to information in various formats.
    3. Provides training to FDA on the library's subscribed electronic
research resources and tools.
    4. Provides consulting and advisory services to FDA staff, through
briefings and participation in scientific and regulatory meetings.
    5. Provides research support through preparation of extensive
literature searches and delivery of customized information packages.
    6. Provides articles and documents to researchers via document
delivery and inter-library loan services.
    7. Monitors and administers the document delivery system, ILLiad,
and the customer relationship management system, ``Ask a Librarian.''
    8. Interprets library and information policy and copyright guidance
for FDA customers.
    9. Manages and coordinates access to bibliographic citation
management systems and consults with researchers to assist with
preparation of bibliographies and citations.
    10. Delivers presentations and briefings at New Employee
Orientations, Awareness Days, Open Houses, and FDA center events to
promote the library resources and services.
    Technical Services Branch:
    1. Ensures the library collections, both online and in print
formats, are responsive to customer research and information needs.
    2. Selects, acquires and manages portfolio of the library's
research resources.

    3. Develops and implements the library's collection development
policy and interprets policy to customers to justify purchase
decisions, collection scope and other criteria.
    4. Collects usage data, customer recommendations and feedback to
determine information resources to maintain and to cancel; administers
acquisition of print and online resources.
    5. Establishes site licenses beneficial to FDA research for all
library subscribed electronic resources.
    6. Establishes pilot tests to evaluate new electronic information
resources; analyzes feedback and makes determinations for purchase
decisions.
    7. Administers the integrated library system and its modules,
including the online public access catalog, the federated search
engine, and the electronic resource management system.
    8. Provides news pushes including the Federal Register, and manages
listservs to provide daily email updates to online newsletters of
interest.
    FDA History Office:
    1. Provides expertise on the history of FDA and its predecessors;
is a key resource for historical records and resources used for Agency
commemoratives, anniversaries and milestones.
    2. Responds to information requests from FDA centers, scholars, the
press, consumers, government agencies, industry, trade organizations,
health professionals, associations, and foreign sources. Presents
information in workshops, briefings, and seminars.
    3. Conducts research and produces publications, briefing reports,
and presentations interpretive of FDA. Maintains an extensive office
research file.
    4. Provides expertise and assesses the historical value of Agency
resources, i.e., records, photographs, films, audio-visual records, and
rare or out-of-print monographs. Leverages FDA resources through
consultative partnerships with FDA offices. Collaborates on
preservation of historical materials with experts at the National
Archives and Records Administration, the National Library of Medicine,
the Smithsonian Institution, and other government, academic, and
private institutions.
    5. Collects, processes, and preserves artifacts that capture the
history of FDA's work, represent the commodities it regulates, and
document the breadth of its responsibilities. Mounts a variety of
exhibits in collaboration with other public and private institutions to
educate Agency employees and the public about the history and work of
the FDA.
    6. Partners with the National Library of Medicine, History of
Medicine Division, to create and make available transcripts and
recordings of an oral history program that documents FDA's
institutional history, through personal interviews with key exiting FDA
employees.
    Office of Real Property Services:
    1. Provides leadership and guidance to Agency components for all
aspects of real property management functions.
    2. Directs the management of programs and systems leading to the
acquisition, alteration, maintenance, and utilization of leased and
owned facilities nationwide, except for the acquisition of buildings
for the White Oak Headquarters Consolidation.
    3. Directs building operations functions for all FDA facilities
nationwide.
    4. Manages the program and provides direct interface GSA for lease
acquisition and lease management for all Agency facilities nationwide.
    5. Serves as liaison with DHHS and GSA for general facilities
management issues and specifically for the efficient management and
operation of facilities occupied by FDA programs nationwide.
    6. Directs and manages an excess of $221 million dollar
appropriation for the acquisition, operation, construction, maintenance
for the Agency's nationwide real property portfolio.
    7. Provides leadership and direction to assure the efficient and
effective utilization of FDA's resources dedicated to engineering
design, facility improvements, and new construction of FDA facilities
nationwide.
    8. Establishes management structure and dialog with GSA and the
architectural engineering design and construction contractors to ensure
FDA program needs and concerns are fully addressed.
    9. Ensures meaningful and continuous communication with community
leaders and associations, State and local governments, and business
leaders in areas where FDA proposes new facilities.
    10. Develops and implements program plans, policies and procedures
designed to create and maintain a safe and healthful environment for
FDA employees, visitors, and guest workers, and to protect the
environment.
    11. Develops Agency plans, policy and procedures consistent with
new environmental health and safety regulatory requirements and Agency
needs.
    12. Provides fire protection, safety engineering, and environmental
health consultation to the Agency's program managers and engineering
offices.
    13. Leads the Agency's decommissioning efforts to close FDA
laboratories and offices from an environmental, safety and health
perspective.
    14. Consults with program officials on safety matters pertaining to
changing and emerging research programs.
    15. Recommends special technical studies to increase the knowledge
of the relationship between occupational safety and environmental
health and laboratory programs of FDA.
    16. Provides support to the FDA Safety Advisory Board and conducts
the FDA Safety and Health Council meetings.
    17. Develops and implements a safety management quality assurance
program for the Agency's multiple work sites nationwide. Develops and
implements a similar headquarters program consistent with the FDA
Safety Advisory Board recommendations and approval.
    Jefferson Laboratories Complex Staff:
    1. Provides leadership and direction regarding all aspects of
facilities management.
    2. Manages and coordinates all aspects of the Jefferson
Laboratories long range facilities planning.
    3. Develops renovation and improvement project definitions and
priorities for inclusion in the Agency's Annual Facilities Plan and
budget.
    4. Provides leadership and direction to assure the efficient and
effective utilization of Jefferson Laboratories resources dedicated to
engineering design, facility improvements, maintenance and new
construction projects.
    Division of Engineering Services:
    1. Manages and directs design and construction requirements for
facility acquisitions within the Agency. These requirements may
encompass the following activities singularly or in combination;
preparation of proposals, preparation of functional requirements,
program of requirements and criteria, architect and engineering
liaison, space design and planning, functional and technical reviews,
preliminary site selections, and project management for facilities
construction, renovation and improvement projects.
    2. Provides engineering guidance and support for all activities
related to maintenance, alterations, and repairs for Agency facilities
nationwide.
    3. Directs and coordinates all Agency facilities programs concerned
with equipment specifications and installation associated with facility
acquisitions. Assists the programs' staffs in developing compatible
facilities and equipment systems for the Agency.

    4. Provides overall engineering services including: Feasibility
studies, design criteria, concept, analysis, and estimates. Schedules
and tracks building and facilities projects and manages project design.
    5. Manages the FDA energy management program; develops Agency
policy relating to the program; develops and enforces supporting Agency
standards that comply with stated goals of DHHS.
    6. Oversight of structural, architectural or mechanical
modifications to accommodate specific requirements in the existing FDA
portfolio.
    7. Prepares computer aided design (CAD) drawings for the Agency and
maintains file of master drawings for FDA portfolio. Maintains and
updates the electronic space occupancy plans for the Agency as part of
the Agency Facilities Management Systems.
    8. Administers Agency contract for renovations/alterations of
office space.
    9. Provides space and alterations project management for existing
FDA space to program components.
    10. Develops, implements and manages integration of facilities
technologies.
    11. Coordinates the Agency's compliance with National Environmental
Policy Act, Resource Conservation and Recovery Act and related news.
    Environment, Safety and Strategic Initiatives Staff:
    1. Manages the Agency's Environment, Safety and Health (EH&S)
Program.
    2. Oversees strategic management initiatives and programs initiated
at Government-wide, Departmental, Agency and Office levels.
    3. Oversees and directs a variety of commercial contracts or
interAgency agreements to ensure smooth and efficient delivery of
services.
    4. Participates in the development of Agency policy involving EH&S
programs and services.
    5. Provides guidance and assistance to the Agency operating
activities on a variety of EH&S and Strategic management issues.
    6. Actively participates in and supports the Agency Facility
Management System used to manage FDA's Real Property Asset inventory.
    7. Receives and implements new initiatives for Real Property
Services (e.g. President Management Agenda initiatives; Office of
Management and Budget Scorecards; Department Objectives and Agency
initiatives).
    Division of Facilities Operations:
    1. Coordinates building operations and facilities management
functions for all FDA owned facilities within the Washington
metropolitan area which includes: Module 1 (MOD 1), and the Beltsville
Research Facility (BRF). Through special delegations of authority from
GSA, maintains responsibility for the total management, operation, and
maintenance of Federal Building 8 (FB-8) and Module 2 (MOD 2).
    2. Oversees and directs a variety of commercial contracts to ensure
smooth and efficient delivery of services.
    3. Participates in the development of Agency policy involving
building management and operations.
    4. Provides guidance and assistance to the Agency operating
activities on a variety of facilities operations issues.
    5. Coordinates office and laboratory relocations and provides
technical assistance to programs regarding effective space utilization.
    6. Provides guidance to program personnel in identifying or
developing alternatives or emergency procedures during scheduled and
unscheduled maintenance interruptions.
    7. Administers Agency contracts for moving services and preventive
maintenance for government owned property.
    8. Manages and coordinates the GSA Delegations of Authority program
for FDA nationwide. Responds, reviews, and analyzes existing and
proposed Delegation Agreements, Interagency Agreements, Memorandum of
Understandings regarding the Agency's nationwide property holdings for
operational planning processes and improvement.
    Portfolio Development Staff:
    1. Plans and develops the Agency Annual Facilities Plan that
includes forecasts for long term, short term and immediate space needs
as well as annual facilities budgets for rent, operations and
maintenance and building and facilities.
    2. Develops multiple strategies for addressing FDA's long and short
range facility plans.
    3. Develops Agency standards and enforcement of occupied and vacant
space utilization. Prepares reports and space management analysis of
the Agency's real property holdings. Analyzes Agency housing plans and
performs real property occupied and vacant space customer analysis.
    4. Provides cost analysis support to Agency components concerned
with leasing, construction, and finance costs.
    5. Manages the policy, acquisition, management and administration
of the Agency's leased real property portfolio.
    6. Provides guidance and assistance to the Agency operating
activities on a variety of nationwide real estate management issues.
    7. Serves as liaison with DHHS and GSA for all lease acquisition
and lease management of FDA nationwide facilities.
    8. Conducts Agency facility studies and develops specific long-
range facility plans for both headquarters and field operations.
    9. Directs or participates in, the preparation of the Program of
Requirements for new construction projects.
    Office of Equal Employment Opportunity and Diversity Management:
    1. Advises and assists the Commissioner and other key officials on
equal employment opportunity (EEO), diversity, and civil rights
activities which impact on policy development and execution of program
goals.
    2. Serves as the Agency focal point and liaison to the Department,
and other Federal agencies, State and local governments, and other
organizations regarding EEO, diversity and civil rights matters.
    3. Develops and recommends policies and priorities designed to
implement the intent of the Office of Personnel Management, Equal
Employment Opportunity Commission, and Office of Civil Rights,
Department of Health and Human Services requirements under Executive
Orders, regulations, EEO and Civil Rights legislation.
    4. Provides leadership, direction, and technical guidance to the
Agency on EEO, diversity and civil rights matters.
    5. Examines the use and impact of administrative mechanisms on work
assignments, pay systems, award systems, performance appraisal systems,
promotion patterns, reorganization impacts, delegations of authority,
management controls, information and documentation systems, and similar
functions of management as they impact upon equal employment
opportunities for all employees within the Agency.
    6. Issues policies, publications and information dissemination
services to Agency employees including Commissioner Policy Statements,
brochures, the EEO Counselors Manual, etc.
    Center for Tobacco Products:
    1. The Center for Tobacco Products will be established to address
the enactment of the Family Smoking Prevention and Tobacco Control Act.
This Office will consist of an Office of Management, an Office of
Policy, an Office of Regulations, and an Office of Science.
    Office of the Center Director:

    1. Provides leadership and direction for all Center activities and
coordinates programs within the Agency, Department, and Government
agencies.
    2. Plans, administers, coordinates, evaluates, and implements
overall Center scientific, regulatory, compliance, enforcement and
management programs, policies and plans.
    3. Provides leadership and direction for Center management,
planning, and evaluation systems to ensure optimum utilization of
personnel, financial resources, and facilities.
    4. Establishes and manages a program to maintain the highest level
of quality and integrity for all Center laboratory studies and the
processing of regulatory samples, and ensures that all laboratories are
in compliance with Good Laboratory Practice Regulations.
    5. Coordinates and monitors the Center's overall research
portfolio, including all research-related activities and inquiries and
the development of strategic research program plans.
    6. Serves as the primary representational role for relationships
with the department, OMB, the White House, the Congress and the media.
    Office of Management:
    1. Provides support to the Center Director and Deputy Directors,
including the coordination and preparation of briefing materials and
background information for meetings, responses to outside inquires, and
maintenance and control of the Center Director's working files.
    2. Manages the Center's Freedom of Information Act activities,
coordinating responses with other Center technical, regulatory, and
policy units as well as developing direct responses.
    3. Provides correspondence control for the Center and controls and
processes all Agency public correspondence directed to the Center
Director. Develops and operates tracking systems designed to identify
and resolve early warnings and bottleneck problems with executive
correspondence.
    4. Coordinates the Center's communications with the Agency,
Department, and the other Federal Government agencies.
    5. Provides authoritative advice and guidance to the Center
Director on management policies, guidelines, issues and concerns that
directly impact Center programs and initiatives.
    6. Provides leadership, guidance and directs the development of
long-range strategic and operational plans and systems for Center
activities and directs technical support staff in providing essential
management services and other critical support functions.
    7. Provides leadership and guidance as primary interface working
with the FDA Office of Shared Services to ensure provision of a broad
range of essential technical support services.
    8. Provides leadership and effective coordination as the primary
Center liaison and expert with the Office of Information Management for
provision and continuous improvement of information and technology
services for the Center to include networking, scientific computing
software engineering, systems, and telecommunications.
    9. Administers and executes Center program planning and performance
activities, budget formulation and execution, payroll, accounting,
fleet and property management functions.
    10. Analyzes, formulates and develops annual budget for the Center
in accordance with FDA, DHHS, OMB and Congressional guidelines.
Provides oversight and ensures compliance with all regulations
governing financial processes as outlined in OMB, GAO, DHHS and FDA
policies.
    11. Manages and maintains a management system for center wide
research and support functions.
    12. Develops, maintains, monitors, analyzes, and reports data to
Center management and program officials on the Center's budget/planning
resource monitoring and evaluations systems.
    13. Manages, conducts, and analyzes studies designed to improve
Center processes and resource utilization and support requirements.
    14. Provides leadership, guidance, technical support and assistance
to Center managers, employees and shared services staff on services
including timekeeping, payroll, fleet management, personal property
management, travel, acquisitions and financial services.
    15. Provides leadership within the Center to assure compliance with
statutes, executive orders and administrative directives, such as the
Chief Financial Officer Act (CFO) and the Federal Financial Manager's
Financial Integrity Act (FMFIA).
    Office of Policy:
    1. Advises the Center Director and other key Agency officials on
matters relating to Agency policy, regulations and guidance,
legislative issues, and planning and evaluation activities.
    2. Participates with the Center Director in the formulation of the
basic policies and operational philosophy, which guide the Agency in
effectively implementing its responsibilities.
    3. Oversees and directs the Centers planning and evaluation
activities, including the development of programs and planning
strategies through analysis and evaluation of issues affecting policies
and program performance.
    4. Advises and assists the Center Director and other key Agency
officials concerning legislative needs, pending legislation and
oversight activities that affect FDA.
    5. Serves as the focal point for overall legislative liaison
activities within Center, FDA and between FDA, DHHS, PHS, and other
agencies related to tobacco; analyzes the legislative needs of the
Center and drafts or develops legislative proposals, position papers,
and departmental reports on proposed legislation for approval by the
Center Director and Commissioner.
    6. Advises and assists members of Congress and congressional
committees and staffs in consultation with the Office of the Secretary,
on Agency actions, policies, and issues related to legislation which
may affect the Center.
    Office of Regulations:
    1. Provides Center oversight and leadership in the development of
regulations, policies, procedures and guidance for the review and
regulation of tobacco products, their labels, and marketing, and in the
development of new legislation.
    2. Provides Center oversight and leadership in the administration
of the user fee billing and waiver program, and registration and
listing.
    3. Coordinates, interprets, and evaluates the Center's overall
compliance efforts. As necessary, establishes compliance policy or
recommends policy to the Center Director.
    4. Oversees and directs the Agency's rulemaking activities and
regulation and guidance development system.
    5. Serves as the Agency focal point for developing and maintaining
communications, policies, and programs with regard to regulations
development.
    6. Stimulates awareness within the Agency of the need for prompt
and positive action to assure compliance by regulated industries; works
to assure an effective and uniform balance between voluntary and
regulatory compliance and Agency responsiveness to consumer needs.
    7. Evaluates and coordinates all proposed legal actions to
ascertain compliance with regulatory policy and enforcement objectives.
    8. Develops and/or recommends to the Center Director policy,
programs, and plans for activities between the Agency and State and
local agencies; administers the Center's overall Federal-State program
and policy; coordinates the program aspects of Agency contracts with
State and local counterpart agencies.

    Office of Science:
    1. Serves as principal authority and provides leadership for the
Center's participation in the National Toxicology Program (NTP).
    2. Organizes, plans, and directs Center research programs in
accordance with Center-wide strategic direction. Implements Center-wide
strategies for achieving annual and long-range plans for research.
    3. Provides leadership and direction for communications among
scientific and administrative staffs.
    4. Organizes, plans, and directs Center research related to tobacco
products.
    5. Directs the development methods used to extrapolate test results
from animals to humans.
    6. Coordinates research in Center program areas with leading
scientists in other segments of FDA and the scientific community at
large and promotes and coordinates the Center's technology transfer
under the provisions of the Federal Technology Transfer Act.
    7. Coordinates with other Center and Agency components and top
level officials of other agencies to provide input for long-term
research planning in responsible program areas.
    8. Ensures that programs implemented are responsive to the Center's
portion of the Agency's integrated research plan.
    9. Provides scientific oversight of Center research contracts and
agreements.
    10. Advises and assists the Center Director, Deputy Director, and
other key officials on scientific issues that have an impact on policy,
direction, and long-range goals.
    11. Coordinates and provides guidance on special and overall
science policy in program areas that cross major Agency component lines
and scientific aspects that are critical or controversial, including
Agency risk assessment policies.
    12. Represents the Center with other government agencies, state and
local governments, industry, academia, consumer organizations,
Congress, national and international organizations, and the scientific
community on tobacco science policy and tobacco science issues.
    13. Serves as the focal point for overall management of Center
activities related to science priorities, resources, and leveraging
efforts, as well as peer review of scientists and scientific programs.
    14. Advises the Commissioner, Deputy Commissioner, and other key
officials on scientific facilities and participates with other Agency
components in planning such facilities.
    15. Administers the Tobacco Advisory Committee that advises the
Center Director, Deputy Director, and other key officials regarding the
quality and direction of tobacco science and scientific issues.
II. Delegation of Authority. Pending further delegation, directives or
orders by the Commissioner of the 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.

    Dated: January 27, 2010.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2010-3161 Filed 2-18-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Notices]
[Page 29939]
[FR Doc No: 2020-10706]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1806-000]

Catalyst Old River Hydroelectric Limited Partnership;
Supplemental Notice That Initial Market-Based Rate Filing Includes
Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced Catalyst Old
River Hydroelectric Limited Partnership's application for market-based
rate authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 2, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: May 13, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-10706 Filed 5-18-20; 8:45 am]
 BILLING CODE 6717-01-P