Statement of Organization, Functions, and Delegations of Authority, 7194-7195 [2018-03402]
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7194
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
biologics license application (BLA) for
DARZALEX (BLA 761,036) was initially
submitted on July 9, 2015.
3. The date the application was
approved: November 16, 2015. FDA has
verified the applicant’s claim that BLA
761,036 was approved on November 16,
2015.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,000 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03342 Filed 2–16–18; 8:45 am]
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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
Office of Regulatory Affairs,
Office of Global Regulatory Operations
AGENCY:
VerDate Sep<11>2014
17:55 Feb 16, 2018
Jkt 244001
and Policy, Food and Drug
Administration, HHS.
ACTION: Notice.
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: 870–
543–4099.
SUMMARY:
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
PO 00000
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Fmt 4703
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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)
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Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
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: https://
www.fda.gov/AboutFDA/Reports
ManualsForms/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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0161]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Food and
Drug Administration-Regulated
Products: Export Certificates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 22,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0498. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Export of Food and Drug
Administration-Regulated Products:
Export Certificates
OMB Control Number 0910–0498—
Extension
In April 1996, the FDA Export,
Reform, and Enhancement Act of 1996
(FDAERA) (Pub. L. 104–134) amended
sections 801(e) and 802 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381(e) and 382). It was
7195
designed to ease restrictions on
exportation of unapproved
pharmaceuticals, biologics, and devices
regulated by FDA. Section 801(e)(4) of
FDAERA provides that persons
exporting certain FDA-regulated
products may request FDA to certify
that the products meet the requirements
of sections 801(e) and 802 or other
requirements of the FD&C Act. This
section of the law requires FDA to issue
certification within 20 days of receipt of
the request and to charge firms up to
$175 for the certifications. In January
2011, section 801(e)(4)(A) was amended
by the FDA Food Safety Modernization
Act (Pub. L. 111–353) to provide
authorization for export certification
fees for food and animal feed.
This section of the FD&C Act
authorizes FDA to issue export
certificates for regulated food, animal
feed, pharmaceuticals, biologics, and
devices that are legally marketed in the
United States, as well as for these same
products that are not legally marketed
but are acceptable to the importing
country, as specified in sections 801(e)
and 802 of the FD&C Act. FDA has
developed various types of certificates
that satisfy the requirements of section
801(e)(4)(B) of the FD&C Act. Four of
those certificates are discussed in this
notice: (1) Certificates to Foreign
Governments, (2) Certificates of
Exportability, (3) Certificates of a
Pharmaceutical Product, and (4) NonClinical Research Use Only Certificates.
FDA has updated the certificates as part
of the proposed collection of
information to account for the
amendment authorizing export
certification fees for food and animal
feed. Table 1 lists the different
certificates and details their uses:
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
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‘‘Supplementary Information Certificate to Foreign Government Requests’’.
‘‘Exporter’s Certification Statement Certificate to Foreign Government’’
‘‘Exporter’s Certification Statement Certificate to Foreign Government
(For Human Tissue Intended for Transplantation)’’.
‘‘Supplementary Information Certificate of Exportability Requests’’ ........
‘‘Exporter’s Certification Statement Certificate of Exportability’’
‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ ...
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical
Product’’.
‘‘Supplementary Information Non-Clinical Research Use Only Certificate’’.
‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’
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For the export of products legally marketed in the United States.
For the export of products not approved for marketing in the United
States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act.
Conforms to the format established by the World Health Organization
and is intended for use by the importing country when the product in
question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or
reviewing a license.
For the export of a non-clinical research use only product, material, or
component that is not intended for human use which may be marketed in, and legally exported from the United States under the
FD&C Act.
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]]>Agencies
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7194-7195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03402]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 870-543-4099.
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)
[[Page 7195]]
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: https://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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