Statement of Organization, Functions, and Delegations of Authority, 68464-68465 [2019-26952]
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
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instructions for submitting comments.
Comments submitted electronically,
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
lotter on DSKBCFDHB2PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Draft Guidance for
Cocaine Hydrochloride.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ will be
publicly viewable at https://
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Management Staff office between 9 a.m.
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• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
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information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
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CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Mara Miller, Center for Drug Evaluation
and Research (HFD–600), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4709C,
Silver Spring, MD 20993–0002, 301–
796–0683.
SUPPLEMENTARY INFORMATION:
that would be used to make productspecific guidances available to the
public on FDA’s website at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs.
As described in that guidance, FDA
adopted this process to develop and
disseminate product-specific guidances
and to provide a meaningful
opportunity for the public to consider
and comment on the guidances. This
notice announces the availability of a
new draft guidance on a generic cocaine
hydrochloride nasal solution.
FDA initially approved new drug
application 209963 GOPRELTO (cocaine
hydrochloride) nasal solution in
December 2017. We are now issuing a
new draft guidance for industry on a
generic cocaine hydrochloride nasal
solution (‘‘Draft Guidance on Cocaine
Hydrochloride’’).
The new draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The new draft guidance, when
finalized, will represent the current
thinking of FDA on the information and
data to demonstrate BE to support
ANDAs for cocaine hydrochloride nasal
solution. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
I. Background
HHS.
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
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II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26971 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA), Center of Drug
Evaluation and Research (CDER) has
modified its structure. This new
organizational structure was approved
SUMMARY:
E:\FR\FM\16DEN1.SGM
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
by the Secretary of Health and Human
Services on September 25, 2019.
FOR FURTHER INFORMATION CONTACT:
Edwin Echegoyen, Acting Director,
Office of Management/Executive
Officer, Food and Drug Administration,
10903 New Hampshire Ave., Building
51, Silver Spring, MD 20993, 301–796–
3300.
lotter on DSKBCFDHB2PROD with NOTICES
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, February 25,
1970; 60 FR 56606, November 9, 1995;
64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August
18, 2009; and 76 FR 45270, July 28,
2011) is amended to reflect the
reorganization of the Center of Drug
Evaluation and Research.
This reorganization consists of the
following Offices: Office of New Drugs
(OND), Office of Translational Science
(OTS), and Office of Pharmaceutical
Quality (OPQ) within the Center for
Drug Evaluation and Research and
revises their functional statements. The
proposed organizational changes align
with the ReImagine HHS strategic shift
moving to the 21st century: Maximizing
Talent, Integrated Assessments, Benefit
Risk Monitoring, and Leveraging the
Power of Data. CDER will meet the
definition of Maximizing Talent by
focusing on growing our scientific
leadership. This will result in clearly
designed pathways to regulatory
approval and enhanced emphasis on
multidisciplinary teams. The proposed
reorganization will integrate
assessments to critically,
collaboratively, and consistently assess
whether information in submissions
meets statutory and regulatory
requirements. OND, OPQ, and OTS will
establish Benefit-Risk Monitoring to
unify the post-market safety
surveillance framework leading to
operational excellence by aligning the
therapeutic focus. Each of these offices
will incorporate Leveraging the Power
of Data to provide access to analytical
tools and systems to help the reviewers
evaluate and interpret submitted data,
thereby improving and streamlining the
processes which will impact the critical
analyses leading to efficiencies and
effectiveness in CDER’s scientific
regulatory review.
Under Part D, FDA, the Center for
Drug Evaluation and Research (CDER)
has been restructured as follows:
Standard Administrative Codes
(SAC). ORGANIZATION—CDER is
VerDate Sep<11>2014
19:21 Dec 13, 2019
Jkt 250001
headed by the Director and includes the
following organizational units:
Office of Regulatory Policy (SAC)
Office of Management (SAC)
Office of Communications (SAC)
Office of Compliance (SAC)
Office of Manufacturing Quality (SAC)
Office of Unapproved Drugs and
Labeling Compliance (SAC)
Office of Scientific Investigations (SAC)
Office of Program and Regulatory
Operations (SAC)
Office of Medical Policy (SAC)
Office of Prescription Drug Promotion
(SAC)
Office of Medical Policy Initiatives
(SAC)
Office of Translational Sciences (SAC)
Office of Biostatistics (SAC)
Office of Clinical Pharmacology (SAC)
Office of Computational Science (SAC)
Office of Study Integrity and
Surveillance (SAC)
Office of Administrative Operations
(SAC)
Office of Executive Programs (SAC)
Office of Surveillance and Epidemiology
(SAC)
Office of Medication Error Prevention
and Risk Management (SAC)
Office of Pharmacovigilance and
Epidemiology (SAC)
Office of New Drugs (SAC)
Office of Administrative Operations
(SAC)
Office of Cardiology, Hematology,
Endocrinology & Nephrology (SAC)
Office of Drug Evaluation Science (SAC)
Office of Immunology & Inflammation
(SAC)
Office of Infectious Diseases (SAC)
Office of Neuroscience (SAC)
Office of New Drug Policy (SAC)
Office of Nonprescription Drugs (SAC)
Office of Oncologic Diseases (SAC)
Office of Program Operations (SAC)
Office of Rare Diseases, Pediatrics,
Urology & Reproductive Medicine
(SAC)
Office of Regulatory Operations (SAC)
Office of Specialty Medicine (SAC)
Office of Therapeutic Biologics and
Biosimilars (SAC)
Office of Strategic Programs (SAC)
Office of Program and Strategic Analysis
(SAC)
Office of Business Informatics (SAC)
Office of Generic Drugs (SAC)
Office of Research Standards (SAC)
Office of Bioequivalence (SAC)
Office of Generic Drug Policy (SAC)
Office of Regulatory Operations (SAC)
Office of Pharmaceutical Quality (SAC)
Office of Administrative Operations
(SAC)
Office of Biotechnology Products (SAC)
Office of Lifecycle Drug Products (SAC)
Office of New Drug Products (SAC)
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Office of Pharmaceutical Manufacturing
Assessment (SAC)
Office of Policy for Pharmaceutical
Quality (SAC)
Office of Program and Regulatory
Operations (SAC)
Office of Quality Surveillance (SAC)
Office of Testing and Research (SAC)
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
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Alex M. Azar, II,
Secretary.
[FR Doc. 2019–26952 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI SPORE
(P50) III Review.
Date: January 29–30, 2020.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68464-68465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26952]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Center of Drug
Evaluation and Research (CDER) has modified its structure. This new
organizational structure was approved
[[Page 68465]]
by the Secretary of Health and Human Services on September 25, 2019.
FOR FURTHER INFORMATION CONTACT: Edwin Echegoyen, Acting Director,
Office of Management/Executive Officer, Food and Drug Administration,
10903 New Hampshire Ave., Building 51, Silver Spring, MD 20993, 301-
796-3300.
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, February 25, 1970;
60 FR 56606, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July
28, 2011) is amended to reflect the reorganization of the Center of
Drug Evaluation and Research.
This reorganization consists of the following Offices: Office of
New Drugs (OND), Office of Translational Science (OTS), and Office of
Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and
Research and revises their functional statements. The proposed
organizational changes align with the ReImagine HHS strategic shift
moving to the 21st century: Maximizing Talent, Integrated Assessments,
Benefit Risk Monitoring, and Leveraging the Power of Data. CDER will
meet the definition of Maximizing Talent by focusing on growing our
scientific leadership. This will result in clearly designed pathways to
regulatory approval and enhanced emphasis on multidisciplinary teams.
The proposed reorganization will integrate assessments to critically,
collaboratively, and consistently assess whether information in
submissions meets statutory and regulatory requirements. OND, OPQ, and
OTS will establish Benefit-Risk Monitoring to unify the post-market
safety surveillance framework leading to operational excellence by
aligning the therapeutic focus. Each of these offices will incorporate
Leveraging the Power of Data to provide access to analytical tools and
systems to help the reviewers evaluate and interpret submitted data,
thereby improving and streamlining the processes which will impact the
critical analyses leading to efficiencies and effectiveness in CDER's
scientific regulatory review.
Under Part D, FDA, the Center for Drug Evaluation and Research
(CDER) has been restructured as follows:
Standard Administrative Codes (SAC). ORGANIZATION--CDER is headed
by the Director and includes the following organizational units:
Office of Regulatory Policy (SAC)
Office of Management (SAC)
Office of Communications (SAC)
Office of Compliance (SAC)
Office of Manufacturing Quality (SAC)
Office of Unapproved Drugs and Labeling Compliance (SAC)
Office of Scientific Investigations (SAC)
Office of Program and Regulatory Operations (SAC)
Office of Medical Policy (SAC)
Office of Prescription Drug Promotion (SAC)
Office of Medical Policy Initiatives (SAC)
Office of Translational Sciences (SAC)
Office of Biostatistics (SAC)
Office of Clinical Pharmacology (SAC)
Office of Computational Science (SAC)
Office of Study Integrity and Surveillance (SAC)
Office of Administrative Operations (SAC)
Office of Executive Programs (SAC)
Office of Surveillance and Epidemiology (SAC)
Office of Medication Error Prevention and Risk Management (SAC)
Office of Pharmacovigilance and Epidemiology (SAC)
Office of New Drugs (SAC)
Office of Administrative Operations (SAC)
Office of Cardiology, Hematology, Endocrinology & Nephrology (SAC)
Office of Drug Evaluation Science (SAC)
Office of Immunology & Inflammation (SAC)
Office of Infectious Diseases (SAC)
Office of Neuroscience (SAC)
Office of New Drug Policy (SAC)
Office of Nonprescription Drugs (SAC)
Office of Oncologic Diseases (SAC)
Office of Program Operations (SAC)
Office of Rare Diseases, Pediatrics, Urology & Reproductive Medicine
(SAC)
Office of Regulatory Operations (SAC)
Office of Specialty Medicine (SAC)
Office of Therapeutic Biologics and Biosimilars (SAC)
Office of Strategic Programs (SAC)
Office of Program and Strategic Analysis (SAC)
Office of Business Informatics (SAC)
Office of Generic Drugs (SAC)
Office of Research Standards (SAC)
Office of Bioequivalence (SAC)
Office of Generic Drug Policy (SAC)
Office of Regulatory Operations (SAC)
Office of Pharmaceutical Quality (SAC)
Office of Administrative Operations (SAC)
Office of Biotechnology Products (SAC)
Office of Lifecycle Drug Products (SAC)
Office of New Drug Products (SAC)
Office of Pharmaceutical Manufacturing Assessment (SAC)
Office of Policy for Pharmaceutical Quality (SAC)
Office of Program and Regulatory Operations (SAC)
Office of Quality Surveillance (SAC)
Office of Testing and Research (SAC)
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
This reorganization is reflected in FDA's Staff Manual Guide (SMG).
Persons interested in seeing the complete SMG can find it on FDA's
website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Alex M. Azar, II,
Secretary.
[FR Doc. 2019-26952 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P
