Statement of Organization, Functions, and Delegations of Authority, 54581-54586 [2020-19325]
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
consortia, and patient groups), and the
general public. The docket number is
FDA–2020–N–1153. The docket will
open on September 1, 2020, and remain
open until September 22, 2020. The
post-marketing pediatric-focused safety
reviews are for the following products
from the following Centers at FDA:
3. ENTERRA THERAPY SYSTEM (HDE)
4. LIPOSORBER LA–15 SYSTEM (HDE)
5. MEDTRONIC ACTIVA DYSTONIA
THERAPY (HDE)
6. PLEXIMMUNE IN–VITRO
DIAGNOSTIC TEST (HDE)
7. PULSERIDER ANEURYSM NECK
RECONSTRUCTION DEVICE (HDE)
Center for Biologics Evaluation and
Research
Dated: August 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
1. AFSTYLA (antihemophilic factor
(recombinant), single chain)
2. EPICEL (cultured epidermal
autografts)
3. FLUCELVAX QUADRIVALENT
(influenza vaccine)
4. FLUCELVAX (influenza vaccine)
5. FLULAVAL (influenza vaccine)
6. FLULAVAL QUADRIVALENT
(influenza vaccine)
7. HIBERIX (Haemophilus b conjugate
vaccine (tetanus toxoid conjugate))
8. KOVALTRY (antihemophilic factor
(recombinant))
9. QPAN H5N1 Vaccine (Influenza A
(H5N1) virus monovalent vaccine,
adjuvanted)
Center for Drug Evaluation and
Research
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Center for Devices and Radiological
Health
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1117]
Janssen Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 16 New
Drug Applications; Correction
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; correction.
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on May 14, 2020. The
document announced the withdrawal of
approval (as of June 15, 2020) of 16 new
drug applications (NDAs) from multiple
applicants. The document indicated that
FDA was withdrawing approval of NDA
050641, Monodox (doxycycline
monohydrate) Capsules, Equivalent to
(EQ) 50 milligrams (mg) base, EQ 75 mg
base, and EQ 100 mg base, after
receiving a withdrawal request from
Aqua Pharmaceuticals, LLC, 707
Eagleview Blvd., Suite 200, Exton, PA
19341. Before FDA withdrew the
approval of NDA 050641, Aqua
Pharmaceuticals, LLC, informed FDA
that it did not want the approval of the
NDA withdrawn. Because Aqua
Pharmaceuticals, LLC, timely requested
that approval of the NDA not be
withdrawn, the approval of NDA
050641 is still in effect.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of May 14, 2020 (85 FR
28950), appearing on page 28950 in FR
Doc. 2020–10367, the following
correction is made:
SUPPLEMENTARY INFORMATION:
1. CONTEGRA PULMONARY VALVED
CONDUIT (Humanitarian Device
Exemption (HDE))
2. ELANA SURGICAL KIT (HDE)
17:33 Sep 01, 2020
BILLING CODE 4164–01–P
SUMMARY:
1. BUTRANS (buprenorphine
transdermal system)
2. CANASA (mesalamine suppositories
for rectal use)
3. DESCOVY (emtricitabine and
tenofovir alafenamide)
4. DRAXIMAGE DTPA (technetium TC–
99m pentetate kit) injection and
inhalation
5. DYSPORT (abobotulinumtoxinA)
6. GENVOYA (elvitegravir, cobicistat,
emtricitabine, and tenofovir
alafenamide) oral tablets
7. LUMASON (sulfur hexafluoride lipidtype A microspheres) injectable
suspension
8. LUMIFY (brimonidine tartrate) OTC
9. LUZU (luliconazole) cream, 1%
10. OMIDRIA (phenylephrine and
ketorolac intraocular solution)
11. SENSIPAR (cinacalcet)
12. STELARA (ustekinumab) injection
13. SYMFI LO (efavirenz 400 milligram
(mg) + lamivudine 300 mg +
tenofovir disoproxil fumarate 300
mg) and SYMFI (efavirenz 600 mg
+ lamivudine 300 mg + tenofovir
disoproxil fumarate 300 mg)
14. TRIUMEQ (abacavir, dolutegravir,
and lamivudine)
15. XEPI (ozenoxacin)
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On page 28951, in the table, the entry
for NDA 050641 is removed.
Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19364 Filed 9–1–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Statement of Organization, Functions,
and Delegations of Authority
August 27, 2020.
Office of the General Counsel,
Office of the Secretary, Department of
Health and Human Services.
This document revises the Statement
of Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services, Office of the General Counsel
(OGC) as published on August 4, 2020
(85 FR 47228) to correct a typographical
error and to better reflect the functions
of the Office. The August 4, 2020
Statement is retracted and replaced by
this document. As revised, it reflects a
new component, changes in titles and
order of succession, and changes in the
law, and is being re-compiled so that the
Statement of Organization incorporates
all amendments, as may be amended
herein, after the issuance of the last
compiled Statement of Organization in
1973. See 38 FR 17032 (June 28, 1973).
SUPPLEMENTARY INFORMATION: The Office
of the Secretary (OS)’s Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services, Office of the General Counsel
(OGC), should now read as follows:
AGENCY:
Section I. Mission
The Mission of the Office of the
General Counsel and the General
Counsel, who is the special advisor to
the Secretary on legal matters, is to
provide all legal services and advice to
the Secretary, Deputy Secretary, and all
subordinate organizational components
of the Department.
Section II Organization
The Office of the General Counsel,
under the supervision of a General
Counsel, consists of:
1. The General Counsel and Immediate
Office of the General Counsel
2. Divisions in the Office of the General
Counsel
3. Ten Regional Offices
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Subsection A. The Immediate Office of
the General Counsel
1. The Immediate Office of the
General Counsel. The Immediate Office
of the General Counsel shall consist of
the General Counsel, his or her
executive assistant, a Principal Deputy
General Counsel, such other Deputy
General Counsel, both non-career and
career, as the Secretary deems
appropriate and appoints, Associate and
Assistant Deputy General Counsel,
Senior Counsel, and such other
attorneys and assistants as the General
Counsel deems appropriate, and the
Office of Legal Resources (OLR).
a. The General Counsel. The General
Counsel is the chief legal officer of the
Department and is directly responsible
to the Secretary.
b. Principal Deputy General Counsel.
The Principal Deputy General Counsel
shall be the second-ranking legal officer
of the Department and is directly
responsible to the General Counsel and
the Secretary. He or she may act in the
stead of the General Counsel when the
General Counsel is absent or
unavailable.
c. Deputy General Counsel. The
Deputy General Counsel report to the
General Counsel and each shall be
responsible for overseeing such
substantive areas as designated by the
General Counsel. In certain instances, a
Deputy General Counsel may be
appointed by the Secretary or assigned
by the General Counsel to serve as the
chief counsel of an operating division.
(1) Non-Career Deputy General
Counsel. Non-career Deputy General
Counsel report to the General Counsel
and each shall be responsible for
overseeing the substantive legal areas
and corresponding OGC components
designated by the General Counsel.
(2) Career Deputy General Counsel.
There shall be two career Deputy
General Counsel who report to the
General Counsel. First, a Deputy
General Counsel who shall oversee OLR,
the General Law Division (GLD), the ten
Regional Offices, and will be generally
responsible for OGC management and
operations subject to the direction of the
General Counsel. Second, a Deputy
General Counsel who shall oversee
litigation and the National Complex
Litigation and Investigations Division
(NCLID).
d. Associate General Counsel.
Associate General Counsel either head a
Division within OGC or are located in
the Immediate Office. In either event,
Associate General Counsel report to the
General Counsel or to such Deputy
General Counsel as the General Counsel
may designate.
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e. Associate or Assistant Deputy
General Counsel to the General Counsel.
The General Counsel may designate one
or more attorneys to act as his or her
special assistant and to carry the title of
Associate Deputy General Counsel or
Assistant Deputy General Counsel, all of
whom shall report directly to the
General Counsel or to such Deputy
General Counsel as the General Counsel
may designate.
f. Senior Counsel or Senior Advisor to
the General Counsel. Senior Counsel or
Senior Advisor to the General Counsel
perform such duties as may be assigned
to them by the General Counsel, Deputy
General Counsel or Associate General
Counsel. At least one Senior Counsel or
Senior Advisor should have a security
clearance of the level and type deemed
appropriate by the General Counsel.
g. Office of Legal Resources. The
Office of Legal Resources within the
Immediate Office of the General
Counsel, headed by a director, is
responsible for providing personnel,
budget, correspondence, and
information technology support to the
Office of the General Counsel.
2. Relation of Immediate Office to the
Divisions and Regions. Each division
and each region is under the general
supervision of the General Counsel and
the assigned Deputy General Counsel,
unless that Division is headed by a
Deputy General Counsel. Each
Divisional Associate General Counsel
and Regional Chief Counsel reports
directly to the assigned Deputy General
Counsel on substantive legal matters,
litigation strategy, and other matters as
directed by the General Counsel.
3. Order of Succession.
a. General Counsel Vacancy. In the
event of the General Counsel’s absence,
or in the event of a ‘‘vacancy’’ in the
position of General Counsel as a result
of death, resignation, or an inability to
perform the functions and duties of the
office, the Principal Deputy General
Counsel shall act in the General
Counsel’s stead, or serve as the Acting
General Counsel as dictated by the
Vacancies Reform Act of 1998, 5 U.S.C.
3345 et seq.
b. Principal Deputy General Counsel
Vacancy. In the event of the absence of
or vacancies in offices of both the
General Counsel and the Principal
Deputy General Counsel, the non-career
Deputy General Counsel with the
greatest seniority in that position shall
perform the functions of or serve as the
Acting General Counsel as dictated by
the Vacancies Reform Act of 1998. In
the event that the disabilities or
vacancies extend to or include all noncareer deputies, then the career Deputy
General Counsel with the greatest
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seniority in that position shall act in or
serve as the Acting General Counsel as
dictated by the Vacancies Reform Act of
1998.
Subsection B. Divisions in the Office of
the General Counsel
The Office of the General Counsel’s
nine divisions are as follows: General
Law Division (GLD); the Children,
Families and Aging Division (CFAD);
the Ethics Division (ETHICSD); the Food
and Drug Division (FDD); the Public
Health Division (Ph.D.); the Legislative
Division (LEGD); the Centers for
Medicare & Medicaid Services Division
(CMSD); the Civil Rights Division
(CRD); and National Complex Litigation
and Investigations Division (NCLID).
Each Division shall be headed by either
an Associate General Counsel or Deputy
General Counsel, as determined by the
General Counsel.
1. The General Law Division shall be
headed by an Associate General Counsel
who reports to the General Counsel
through a career Deputy General
Counsel. The Division consists of two
branches, each headed by a Deputy
Associate General Counsel reporting to
the Associate General Counsel:
a. Claims and Employment Law Branch
b. Procurement, Fiscal and Information
Law Branch
2. The Children, Families and Aging
Division shall be headed by an
Associate General Counsel who reports
to the General Counsel through a
designated Deputy General Counsel.
3. The Ethics Division shall be headed
by an Associate General Counsel who
reports to the General Counsel. The
Division consists of two branches, each
headed by a Deputy Associate General
Counsel reporting to the Associate
General Counsel:
a. Ethics Advice and Policy Branch
b. Ethics Program Administration
Branch
The Associate General Counsel and
Deputy Associate for Ethics Advice and
Policy simultaneously serve by
secretarial delegation as the
Department’s Designated Agency Ethics
Official and Alternate Designated
Agency Ethics Official, respectively.
4. The Food and Drug Division shall
be headed by a Chief Counsel who shall
be either a Deputy General Counsel or
Associate General Counsel. In the event
that the Chief Counsel is an Associate
General Counsel, he or she shall report
to the General Counsel through a
designated Deputy General Counsel.
The Division consists of two major
branches, each of which is headed by a
Deputy Associate General Counsel who
reports to the Chief Counsel, as follows:
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a. Litigation Branch
b. Program Review Branch, divided into
the following three sub-branches:
(1) Foods & Veterinary Medicine
(2) Drugs and Biologics
(3) Tobacco & Devices
5. The Public Health Division shall be
headed by an Associate General Counsel
who reports to the General Counsel
through a designated Deputy General
Counsel. The Division is divided into
four branches, each of which is headed
by a Deputy Associate General Counsel
reporting to the Associate General
Counsel:
a. Indian Health Service Branch
b. Centers for Disease Control and
Prevention Branch
c. National Institutes of Health Branch
d. Public Health and Science Branch
6. The Legislation Division shall be
headed by an Associate General Counsel
who reports to the General Counsel
through a designated Deputy General
Counsel.
7. The Centers for Medicare &
Medicaid Services Division shall be
headed by a Chief Legal Officer who
shall be either a Deputy General
Counsel or an Associate General
Counsel. The Division consists of three
major organizational groups, each of
which is headed by a Deputy Associate
General Counsel reporting to the
Associate General Counsel or the
Deputy General Counsel through an
Associate General Counsel, as follows:
a. Litigation Group
b. Program Review Group
c. Program Integrity Group
8. The Civil Rights Division shall be
headed by an Associate General Counsel
who reports to the General Counsel
through a designated Deputy General
Counsel, and by a Deputy Associate
General Counsel who reports to the
Associate General Counsel.
9. The National Complex Litigation
and Investigations Division (NCLID) has
an Associate General Counsel who
reports to General Counsel through a
career Deputy General Counsel. In
addition, NCLID has a Deputy Associate
General Counsel for E-Discovery
reporting to the Associate General
Counsel.
Subsection C. Regional Offices
There are ten regional offices. Each
regional office has a Chief Counsel who
reports to the General Counsel through
a designated career Deputy General
Counsel. Regional offices may also have
one or more Deputy Chief Counsel who
report to the Chief Counsel. The
regional offices are located in the
following cities and provide legal
services to the Department in the
following states and territories:
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1. Region I—Boston (Connecticut,
Maine, Massachusetts, New
Hampshire, Rhode Island, Vermont)
2. Region II—New York City (New York,
New Jersey, Puerto Rico, Virgin
Islands)
3. Region III—Philadelphia (Delaware,
Maryland, Pennsylvania, Virginia,
West Virginia, District of Columbia)
4. Region IV—Atlanta (Alabama,
Florida, Georgia, Kentucky,
Mississippi, North Carolina, South
Carolina, Tennessee)
5. Region V—Chicago (Illinois, Indiana,
Ohio, Michigan, Minnesota,
Wisconsin)
6. Region VI—Dallas (Arkansas,
Louisiana, New Mexico, Oklahoma,
Texas)
7. Region VII—Kansas City, MO (Iowa,
Kansas, Missouri, Nebraska)
8. Region VIII—Denver (Colorado,
Montana, North Dakota, South
Dakota, Utah, Wyoming)
9. Region IX—San Francisco (Arizona,
California, Hawaii, Nevada, Guam,
American Samoa, Commonwealth
of the Northern Mariana Islands, the
Federated States of Micronesia, the
Republic of the Marshall Islands,
the Republic of Palau)
10. Region X—Seattle (Alaska, Idaho,
Oregon, Washington)
Section III. Functions
A. General Counsel and Immediate
Office of the General Counsel
1. The General Counsel. The General
Counsel is authorized to promulgate
such directives and issue such legal
opinions as may be necessary to carry
out the responsibilities of the Office.
The General Counsel directly (or
through attorneys in the Office of the
General Counsel), undertakes the
following activities unless an applicable
statute provides otherwise or the
General Counsel has delegated the
responsibility elsewhere:
a. Furnishes all legal services and
advice to the Secretary, Deputy
Secretary, and all offices, branches, or
units of the Department in connection
with the operations and administration
of the Department and its programs,
except with respect to functions
expressly delegated by statute to the
Inspector General.
b. Furnishes legal services and advice
on such other matters as may be
submitted by the Secretary, the Deputy
Secretary, any other senior leaders, and
other persons authorized by the
Secretary to request such service or
advice.
c. Represents the Department in all
litigation when such direct
representation is not precluded by law,
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and in other cases, making and
supervising all contacts with attorneys
responsible for the conduct of such
litigation.
d. Acts as the Department’s sole
representative in communicating with
the Department of Justice, including all
United States Attorneys, on all civil
matters and on all criminal matters,
other than those criminal matters
referred to the Department of Justice by
the Inspector General.
e. Acts as the Department’s sole
representative in communicating with
Office of White House Counsel or the
Offices of General Counsel for any other
Department or Agency.
f. Performs all liaison functions in
connection with legal matters involving
the Department, and formulating or
reviewing requests for formal opinions
or rulings by the Attorney General and
the Comptroller General.
g. Issues pre-enforcement rulings or
advisory opinions to the public on
questions of law, except to the extent
that that such authority has previously
been delegated to the Inspector General
under section 1128D of the Social
Security Act.
h. Authorizes indemnification, as
appropriate, pursuant to 45 CFR part 36.
i. Conducts internal investigations at
the request of the Secretary or Deputy
Secretary, or for matters that could lead
to litigation.
j. Drafts all proposals for legislation
originating in the Department and
reviewing all proposed legislation
submitted to the Department or to any
operating agency of the Department for
comment; preparing reports and letters
to congressional committees, the Office
of Management and Budget, and others
on proposed legislation; and prescribing
procedures to govern the routing and
review, within the Department, of
material relating to proposed Federal
legislation.
k. Performs liaison functions with the
Office of the Federal Register, National
Archives and Records Service.
l. Reviews and approves all
administrative complaints and
enforcement actions by any agency
within the Department before those
complaints are filed or transmitted, or
enforcement actions instituted to ensure
that the complaint or enforcement
action is legally sound.
m. Leads all negotiations on behalf of
any agency within the Department.
n. Supervises all legal activities of the
Department and its operating agencies.
o. Ensures that no one in the
Department, other than those in OGC or
expressly authorized by statute to do so,
provides any legal advice to anyone in
the Department or uses any title that
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implies that they are functioning as a
departmental lawyer.
2. Principal Deputy General Counsel.
The Principal Deputy General Counsel
is the second ranking legal officer in the
Department and performs the functions
of the General Counsel in his or her
absence or disability, including recusal,
and, unless otherwise noted, oversees
for the General Counsel all litigation
involving the Department, its officers,
inferior officers, and employees.
3. Deputy General Counsel. The
Deputy General Counsel assist the
General Counsel in carrying out his or
her responsibilities and performs such
duties as the General Counsel or
Principal Deputy General Counsel may
assign. The Associate General Counsel
for a Division shall report to the General
Counsel through one or more Deputy
General Counsel, as may be assigned by
the General Counsel. Regional Chief
Counsel shall report to the General
Counsel through a career Deputy
General Counsel.
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B. Functions, Authorities and
Responsibilities of the Divisions
The Divisions within OGC provide
legal counsel to their clients, as
described below, subject to the
professional supervision and control of
the General Counsel and assigned
Deputy General Counsel.
1. General Law Division. The General
Law Division, acting through its
Associate General Counsel, performs the
following:
a. Provides legal services on business
management activities and
administrative operations throughout
the Department, including employment,
compensation, personnel,
appropriations, real and personal
property (including National
Environmental Policy Act),
procurement, information, travel, and
certain claims by and against the
Department.
b. Represents the Department in all
aspects of administrative litigation
before the Merit Systems Protection
Board (MSPB), Equal Employment
Opportunity Commission (EEOC), and
in labor arbitrations, as needed. Acts as
agency counsel in support of the
Department of Justice on employment
cases filed in federal court.
c. Represents the Department in bid
protests filed before the Comptroller
General and contract disputes filed
before the Civilian Board of Contract
Appeals. Acts as agency counsel in
support of the Department of Justice in
bid protests and contract disputes filed
before the U.S. Court of Federal Claims
and appealed to the Federal Circuit.
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d. Provides legal services to
Department Freedom of Information Act
(FOIA) Officers on the disclosure of
agency records requested under FOIA,
and communicates with the Department
of Justice on the administration of the
Freedom of Information Act.
e. Provides legal services to the
Department on the Privacy Act of 1974,
as amended, the Paperwork Reduction
Act, the Federal Records Act, and the
Government in the Sunshine Act.
f. Provides all legal services with
respect to the formation, maintenance,
and administration of the advisory
committees under the Federal Advisory
Committee Act.
g. Acts as the Department Claims
Officer, responsible for adjudicating all
administrative claims filed under the
Federal Tort Claims Act, approval of
claims filed under the Federal Medicare
Recovery Claims Act in amounts of at
least $20,000 but not exceeding
$300,000, tort liability claims under the
U.S. Constitution and other laws under
which claims for money damages may
be filed with the Department, as
provided by 5 U.S.C. 5584, 10 U.S.C.
2774, except for claims arising under
the Social Security Act. Also
responsible for making final
determinations on legally enforceable
non tax debts owed to the United States
government arising from HHS programs
under the Federal Claims Collection
Act, as amended, 31 U.S.C. 3711 et seq.,
on the compromise of, and the
suspension or termination of collection
activities for, claims in amounts of
$100,000 or less, exclusive of interest,
and on the waiver of interest.
2. Children, Families, and Aging
Division. The Children, Families, and
Aging Division Provides legal services
to the Administration for Children and
Families and its various agencies
including the Office of Refugee
Resettlement and Administration for
Community Living.
3. Ethics Division. The Ethics Division
administers and oversees Departmentwide implementation of comprehensive
government ethics program
requirements under the Ethics in
Government Act of 1978, as amended,
Executive Order 12731, and
implementing regulations at 5 CFR part
2638. The Division, without limitation,
performs the following:
a. Provides legal advice and policy
guidance on interpretation and
compliance issues involving the
criminal conflict of interest statutes, 18
U.S.C. 210–219, political activity
restrictions, anti-lobbying provisions,
outside activity limitations, travel
reimbursement guidelines, procurement
integrity rules, financial disclosure
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obligations, and standards of ethical
conduct matters including gifts between
employees and from outside sources,
conflicting financial interests and
impartiality concerns, misuse of
position and agency resources, and
outside employment, fundraising,
testimony, and teaching, speaking or
writing, to Department officials, agency
personnel, advisory committees and
others.
b. Reviews executive branch public
financial disclosure reports submitted
by Presidential nominees/appointees
subject to Senate confirmation, noncareer SES and Schedule C political
appointees, OGC career SES officials,
and Op/Staff Division ethics officials
(DECs) to assess potential violations of
applicable laws or regulations, ensure
transparency through accurate
reporting, provide counseling on the
avoidance of conflicts, and, if necessary,
recommending appropriate corrective
action, including drafting waivers,
disqualification statements, ethics
agreements, and certificate of divestiture
materials; ensuring identical review and
counseling responsibilities with respect
to both the public and confidential
financial disclosure forms filed by
career employees are performed
Department-wide by the DECs.
c. Plans, develops, and provides
initial ethics orientation for new
employees, annual ethics training for
employees who file financial disclosure
forms and others occupying certain
sensitive positions, initial and annual
ethics training for members of federal
advisory committees, and specialized,
topic-specific training on postemployment restrictions, political
activity restrictions, insider trading, and
procurement integrity rules.
d. Monitors component ethics
programs and reviewing compliance
with core ethics program elements,
including advice, financial disclosure,
outside activities, conflict of interest
waivers, ethics agreements and travel
payments from non-federal sources.
e. Communicates on matters related to
government ethics with the Office of
Counsel to the President, the Office of
Government Ethics, the Office of Special
Counsel, the Office of the Inspector
General, Special Investigations Unit, the
Office of Personnel Management, and
the General Services Administration.
f. Develops component-specific
conduct regulations and implementing
procedures.
4. Food and Drug Division. The Food
and Drug Division acts as the
Commissioner’s legal advisor and
provides legal services to FDA. FDD, for
example, performs the following:
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a. Represents the FDA in connection
with judicial and administrative
proceedings involving programs
administered by the FDA. Provides legal
advice and policy guidance for
programs administered by the FDA.
b. Acts as the Department and FDA’s
sole liaison to the Department of Justice
and other Federal Departments for
programs administered by FDA; all
criminal prosecutions, investigations,
and civil matters may only be referred
to the Department of Justice through the
Chief Counsel.
c. Drafts or reviews all proposed and
final regulations and Federal Register
notices prepared by FDA.
d. Performs legal research and gives
legal opinions on regulatory issues,
actions, and petitions submitted to FDA.
e. Reviews proposed legislation
affecting FDA that originates in the
Department or on which Congress
requests the views of the Department.
f. Provides legal advice and assistance
to the Office of the Secretary on matters
within the expertise of the Chief
Counsel.
5. Public Health Division. The Public
Health Division provides legal services
to all Public Health Service agencies
(except to the Food and Drug
Administration) and their programs,
including the Office of the Surgeon
General and the Commissioned Corps of
the U.S. Public Health Service.
Represented Public Health Service
agencies include, but are not limited to
the (i) the Office of the Assistant
Secretary for Health, and its various
programs, (ii) the Office of the
Secretary’s Office of Minority Health,
(iii) the Centers for Disease Control and
Prevention, (iv) the National Institutes
of Health, (v) the Health Resources and
Services Administration, (vi) the Indian
Health Service, (vii) the Substance
Abuse and Mental Health Services
Administration, (viii) the Agency for
Healthcare Research and Quality, and
(ix) the Office of the Assistant Secretary
for Preparedness and Response. In
addition, the Public Health Service
Division serves as the lead office within
the Office of the General Counsel for
grants-related and intellectual property
issues, other than federal court or PTAB
litigation.
6. Legislation Division. The
Legislation Division performs the
following:
a. Drafts all proposed legislation
originating in the Department,
reviewing specifications for such
proposed legislation, and reviewing all
proposed legislation submitted to the
Department or to any constituent unit of
the Department for comment.
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b. Prepares or reviews reports and
letters to Congressional Committees, the
Office of Management and Budget, and
others on proposed legislation.
c. Reviews proposed testimony of
Department officials before
Congressional Committees relating to
pending or proposed legislation.
d. Acts as Department liaison with the
Office of Management and Budget on
legislative matters.
e. Prescribes procedures to govern the
routing and review, within the
Department, of material relating to
proposed Federal legislation.
7. Centers for Medicare & Medicaid
Services Division. The Centers for
Medicare & Medicaid Services Division,
acting through the Deputy General
Counsel serving as the CMS Chief Legal
Officer or an Associate General Counsel,
a. Acts as the CMS Administrator’s
legal advisor.
b. Represents CMS and the Office of
the National Coordinator for Health
Information Technology (‘‘ONC’’) in
court proceedings and administrative
hearings with respect to programs
administered by CMS or ONC.
c. Provides legal advice and policy
guidance for programs administered by
CMS and ONC.
d. Acts as the Department’s and
CMS’s and ONC’s liaison to the
Department of Justice and other Federal
Departments for programs administered
by those operating divisions.
e. Drafts or reviews all proposed and
final regulations and Federal Register
notices prepared by CMS, ONC, and
other agencies.
f. Performs legal research and gives
legal opinions on regulatory issues,
actions, and petitions submitted to CMS
and ONC.
g. Reviews proposed legislation
affecting CMS, ONC, Office of Medicare
Hearing Appeals (OMHA) and DAB that
originates in the Department or on
which Congress requests the views of
the Department.
h. Provides legal advice and
assistance to the Office of the Secretary
on matters within the expertise of the
CMS Chief Legal Officer.
i. Provides legal advice and assistance
to the Office of the Secretary on matters
relating to the COVID–19 Provider
Relief Fund (PRF) and similar provider
relief programs, including advice
regarding the administration of the PRF,
civil litigation relating to the PRF, and
fraud and abuse involving PRF
payments.
8. Civil Rights Division. The Civil
Rights Division provides legal services
for the Office for Civil Rights (OCR) and
provides legal advice with respect to the
civil rights laws to all agencies and
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54585
offices within the Department, and in
coordination with the assigned Deputy
General Counsel, evaluates complaints,
advises whether there is legal basis to
proceed, assists OCR in developing and
implementing investigation plans, and
clears the imposition of any civil money
penalties. CRD likewise represents the
Department in administrative
proceedings and federal litigation,
together with the Department of Justice.
CRD provides these legal services with
respect to:
a. Traditional civil rights laws such
as, by way of example, title VI of the
Civil Rights Act of 1964 (42 U.S.C.
2000d et seq.), title IX of the Education
Amendments of 1972 (20 U.S.C. 1681 et
seq.), the Age Discrimination Act of
1975 (42 U.S.C. 6101 et seq.), section
504 of the Rehabilitation Act of 1973 (29
U.S.C. 794), the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101
et seq. and 47 U.S.C. 225, 661), section
1557 of the Affordable Care Act (42
U.S.C. 18116).
b. Conscience statutes, such as the
Church Amendments, the Weldon
Amendment, and the Coats-Snowe
Amendment.
c. The Health Insurance and
Portability and Accountability Act of
1996 (Social Security Act section 1171
et seq.), the Health Information
Technology for Economic and Clinical
Health (HITECH) Act, and the rules
implementing them.
The authorities of CRD and the
General Counsel described here do not
supersede the terms of any statute,
regulation, or delegation granting
authority or responsibility to OCR.
9. National Complex Litigation and
Investigations Division. The National
Complex Litigation and Investigations
Division provides legal services across
the Department, as directed by the
General Counsel or Principal Deputy
General Counsel. In that regard, NCLID,
performs the following:
a. Coordinates litigation spanning
multiple OGC divisions, regional
offices, or geographic areas.
b. Provides legal services in
connection with complex litigation or
anticipated complex litigation by or
against the Department. Such litigation
may include cases for which other OGC
divisions or OGC regions request NCLID
participation; cases spanning multiple
OGC divisions or regional offices, or
cases outside the scope of other OGC
divisions or regional offices.
c. Conducts internal investigations at
the request of the Secretary or Deputy
Secretary, or on matters that could lead
to litigation.
d. Administers the OGC-wide ediscovery program, and coordinates the
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
use of e-discovery technology with other
HHS staff and operating divisions.
e. Identifies and supports the
implementation of best practices for
litigation management, e-discovery, and
virtual staffing across OGC.
C. Functions, Authorities and
Responsibilities of the Regions
The Chief Counsel of each Region is
HHS’ legal representative in that Region.
Regional offices within OGC provide a
full range of legal services including, by
way of example, legal counsel to their
departmental clients and client agencies
in the regions, as described below,
subject to the professional supervision
and direction of the General Counsel.
The Office of the General Counsel’s
ten regional offices provide legal advice,
administrative and judicial litigation
support and counseling services to the
regional components of the Department.
Regional attorneys provide general law
support to regional clients and handle
work in most areas within HHS’
jurisdiction with particular emphasis on
litigation for, among others, CMS, ACF,
OCR, CDC, and IHS. Regional offices
also provide leadership with respect to
bankruptcy cases. In the area of civil
rights, they work in close consultation
with the Associate General Counsel for
the Civil Rights Division to ensure that
the regional positions align closely with
those of the Division thereby fostering
national uniformity. In other areas, the
Divisions and Regions work
collaboratively to provide consistent,
uniform legal advice.
Dated: August 27, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–19325 Filed 8–28–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute of Neurological
Disorders and Stroke; 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,
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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: Neurological Sciences
Training Initial Review Group; NST–1,
Subcommittee NST–1.
Date: September 21–22, 2020.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC,
6001 Executive Boulevard, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS, NIH, NSC, 6001 Executive Blvd.,
Suite 3204, MSC 9529, Bethesda, MD 20892–
9529, (301) 496–0660, benzingw@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, NST–1 Member Conflict
Review Panel.
Date: September 22, 2020.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC,
6001 Executive Boulevard, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS, NIH NSC, 6001 Executive Blvd.,
Suite 3204, MSC 9529, Bethesda, MD 20892–
9529, (301) 496–0660, benzingw@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: August 27, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–19318 Filed 9–1–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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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: Risk, Prevention and
Health Behavior Integrated Review Group;
Behavioral Medicine, Interventions and
Outcomes Study Section.
Date: October 5–6, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mark Allen Vosvick, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
Bethesda, MD 20892, 301–402–4128,
mark.vosvick@nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Behavioral Genetics and Epidemiology Study
Section.
Date: October 6–7, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Andrew Louden, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3137,
Bethesda, MD 20817, 301–435–1985,
loudenan@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; S10
Programs for Shared Instrumentation Grant
(SIG) and Shared Instrumentation for Animal
Research (SIFAR) Grant.
Date: October 6, 2020.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jan Li, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
Bethesda, MD 20892, 301.402.9607, Jan.Li@
nih.gov.
Name of Committee: Oncology 1-Basic
Translational Integrated Review Group;
Molecular Oncogenesis Study Section.
Date: October 7–8, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\02SEN1.SGM
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Agencies
[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Pages 54581-54586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19325]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Statement of Organization, Functions, and Delegations of
Authority
August 27, 2020.
AGENCY: Office of the General Counsel, Office of the Secretary,
Department of Health and Human Services.
This document revises the Statement of Organization, Functions, and
Delegations of Authority for the Department of Health and Human
Services, Office of the General Counsel (OGC) as published on August 4,
2020 (85 FR 47228) to correct a typographical error and to better
reflect the functions of the Office. The August 4, 2020 Statement is
retracted and replaced by this document. As revised, it reflects a new
component, changes in titles and order of succession, and changes in
the law, and is being re-compiled so that the Statement of Organization
incorporates all amendments, as may be amended herein, after the
issuance of the last compiled Statement of Organization in 1973. See 38
FR 17032 (June 28, 1973).
SUPPLEMENTARY INFORMATION: The Office of the Secretary (OS)'s Statement
of Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services, Office of the General Counsel
(OGC), should now read as follows:
Section I. Mission
The Mission of the Office of the General Counsel and the General
Counsel, who is the special advisor to the Secretary on legal matters,
is to provide all legal services and advice to the Secretary, Deputy
Secretary, and all subordinate organizational components of the
Department.
Section II Organization
The Office of the General Counsel, under the supervision of a
General Counsel, consists of:
1. The General Counsel and Immediate Office of the General Counsel
2. Divisions in the Office of the General Counsel
3. Ten Regional Offices
[[Page 54582]]
Subsection A. The Immediate Office of the General Counsel
1. The Immediate Office of the General Counsel. The Immediate
Office of the General Counsel shall consist of the General Counsel, his
or her executive assistant, a Principal Deputy General Counsel, such
other Deputy General Counsel, both non-career and career, as the
Secretary deems appropriate and appoints, Associate and Assistant
Deputy General Counsel, Senior Counsel, and such other attorneys and
assistants as the General Counsel deems appropriate, and the Office of
Legal Resources (OLR).
a. The General Counsel. The General Counsel is the chief legal
officer of the Department and is directly responsible to the Secretary.
b. Principal Deputy General Counsel. The Principal Deputy General
Counsel shall be the second-ranking legal officer of the Department and
is directly responsible to the General Counsel and the Secretary. He or
she may act in the stead of the General Counsel when the General
Counsel is absent or unavailable.
c. Deputy General Counsel. The Deputy General Counsel report to the
General Counsel and each shall be responsible for overseeing such
substantive areas as designated by the General Counsel. In certain
instances, a Deputy General Counsel may be appointed by the Secretary
or assigned by the General Counsel to serve as the chief counsel of an
operating division.
(1) Non-Career Deputy General Counsel. Non-career Deputy General
Counsel report to the General Counsel and each shall be responsible for
overseeing the substantive legal areas and corresponding OGC components
designated by the General Counsel.
(2) Career Deputy General Counsel. There shall be two career Deputy
General Counsel who report to the General Counsel. First, a Deputy
General Counsel who shall oversee OLR, the General Law Division (GLD),
the ten Regional Offices, and will be generally responsible for OGC
management and operations subject to the direction of the General
Counsel. Second, a Deputy General Counsel who shall oversee litigation
and the National Complex Litigation and Investigations Division
(NCLID).
d. Associate General Counsel. Associate General Counsel either head
a Division within OGC or are located in the Immediate Office. In either
event, Associate General Counsel report to the General Counsel or to
such Deputy General Counsel as the General Counsel may designate.
e. Associate or Assistant Deputy General Counsel to the General
Counsel. The General Counsel may designate one or more attorneys to act
as his or her special assistant and to carry the title of Associate
Deputy General Counsel or Assistant Deputy General Counsel, all of whom
shall report directly to the General Counsel or to such Deputy General
Counsel as the General Counsel may designate.
f. Senior Counsel or Senior Advisor to the General Counsel. Senior
Counsel or Senior Advisor to the General Counsel perform such duties as
may be assigned to them by the General Counsel, Deputy General Counsel
or Associate General Counsel. At least one Senior Counsel or Senior
Advisor should have a security clearance of the level and type deemed
appropriate by the General Counsel.
g. Office of Legal Resources. The Office of Legal Resources within
the Immediate Office of the General Counsel, headed by a director, is
responsible for providing personnel, budget, correspondence, and
information technology support to the Office of the General Counsel.
2. Relation of Immediate Office to the Divisions and Regions. Each
division and each region is under the general supervision of the
General Counsel and the assigned Deputy General Counsel, unless that
Division is headed by a Deputy General Counsel. Each Divisional
Associate General Counsel and Regional Chief Counsel reports directly
to the assigned Deputy General Counsel on substantive legal matters,
litigation strategy, and other matters as directed by the General
Counsel.
3. Order of Succession.
a. General Counsel Vacancy. In the event of the General Counsel's
absence, or in the event of a ``vacancy'' in the position of General
Counsel as a result of death, resignation, or an inability to perform
the functions and duties of the office, the Principal Deputy General
Counsel shall act in the General Counsel's stead, or serve as the
Acting General Counsel as dictated by the Vacancies Reform Act of 1998,
5 U.S.C. 3345 et seq.
b. Principal Deputy General Counsel Vacancy. In the event of the
absence of or vacancies in offices of both the General Counsel and the
Principal Deputy General Counsel, the non-career Deputy General Counsel
with the greatest seniority in that position shall perform the
functions of or serve as the Acting General Counsel as dictated by the
Vacancies Reform Act of 1998. In the event that the disabilities or
vacancies extend to or include all non-career deputies, then the career
Deputy General Counsel with the greatest seniority in that position
shall act in or serve as the Acting General Counsel as dictated by the
Vacancies Reform Act of 1998.
Subsection B. Divisions in the Office of the General Counsel
The Office of the General Counsel's nine divisions are as follows:
General Law Division (GLD); the Children, Families and Aging Division
(CFAD); the Ethics Division (ETHICSD); the Food and Drug Division
(FDD); the Public Health Division (Ph.D.); the Legislative Division
(LEGD); the Centers for Medicare & Medicaid Services Division (CMSD);
the Civil Rights Division (CRD); and National Complex Litigation and
Investigations Division (NCLID). Each Division shall be headed by
either an Associate General Counsel or Deputy General Counsel, as
determined by the General Counsel.
1. The General Law Division shall be headed by an Associate General
Counsel who reports to the General Counsel through a career Deputy
General Counsel. The Division consists of two branches, each headed by
a Deputy Associate General Counsel reporting to the Associate General
Counsel:
a. Claims and Employment Law Branch
b. Procurement, Fiscal and Information Law Branch
2. The Children, Families and Aging Division shall be headed by an
Associate General Counsel who reports to the General Counsel through a
designated Deputy General Counsel.
3. The Ethics Division shall be headed by an Associate General
Counsel who reports to the General Counsel. The Division consists of
two branches, each headed by a Deputy Associate General Counsel
reporting to the Associate General Counsel:
a. Ethics Advice and Policy Branch
b. Ethics Program Administration Branch
The Associate General Counsel and Deputy Associate for Ethics Advice
and Policy simultaneously serve by secretarial delegation as the
Department's Designated Agency Ethics Official and Alternate Designated
Agency Ethics Official, respectively.
4. The Food and Drug Division shall be headed by a Chief Counsel
who shall be either a Deputy General Counsel or Associate General
Counsel. In the event that the Chief Counsel is an Associate General
Counsel, he or she shall report to the General Counsel through a
designated Deputy General Counsel. The Division consists of two major
branches, each of which is headed by a Deputy Associate General Counsel
who reports to the Chief Counsel, as follows:
[[Page 54583]]
a. Litigation Branch
b. Program Review Branch, divided into the following three sub-
branches:
(1) Foods & Veterinary Medicine
(2) Drugs and Biologics
(3) Tobacco & Devices
5. The Public Health Division shall be headed by an Associate
General Counsel who reports to the General Counsel through a designated
Deputy General Counsel. The Division is divided into four branches,
each of which is headed by a Deputy Associate General Counsel reporting
to the Associate General Counsel:
a. Indian Health Service Branch
b. Centers for Disease Control and Prevention Branch
c. National Institutes of Health Branch
d. Public Health and Science Branch
6. The Legislation Division shall be headed by an Associate General
Counsel who reports to the General Counsel through a designated Deputy
General Counsel.
7. The Centers for Medicare & Medicaid Services Division shall be
headed by a Chief Legal Officer who shall be either a Deputy General
Counsel or an Associate General Counsel. The Division consists of three
major organizational groups, each of which is headed by a Deputy
Associate General Counsel reporting to the Associate General Counsel or
the Deputy General Counsel through an Associate General Counsel, as
follows:
a. Litigation Group
b. Program Review Group
c. Program Integrity Group
8. The Civil Rights Division shall be headed by an Associate
General Counsel who reports to the General Counsel through a designated
Deputy General Counsel, and by a Deputy Associate General Counsel who
reports to the Associate General Counsel.
9. The National Complex Litigation and Investigations Division
(NCLID) has an Associate General Counsel who reports to General Counsel
through a career Deputy General Counsel. In addition, NCLID has a
Deputy Associate General Counsel for E-Discovery reporting to the
Associate General Counsel.
Subsection C. Regional Offices
There are ten regional offices. Each regional office has a Chief
Counsel who reports to the General Counsel through a designated career
Deputy General Counsel. Regional offices may also have one or more
Deputy Chief Counsel who report to the Chief Counsel. The regional
offices are located in the following cities and provide legal services
to the Department in the following states and territories:
1. Region I--Boston (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont)
2. Region II--New York City (New York, New Jersey, Puerto Rico, Virgin
Islands)
3. Region III--Philadelphia (Delaware, Maryland, Pennsylvania,
Virginia, West Virginia, District of Columbia)
4. Region IV--Atlanta (Alabama, Florida, Georgia, Kentucky,
Mississippi, North Carolina, South Carolina, Tennessee)
5. Region V--Chicago (Illinois, Indiana, Ohio, Michigan, Minnesota,
Wisconsin)
6. Region VI--Dallas (Arkansas, Louisiana, New Mexico, Oklahoma, Texas)
7. Region VII--Kansas City, MO (Iowa, Kansas, Missouri, Nebraska)
8. Region VIII--Denver (Colorado, Montana, North Dakota, South Dakota,
Utah, Wyoming)
9. Region IX--San Francisco (Arizona, California, Hawaii, Nevada, Guam,
American Samoa, Commonwealth of the Northern Mariana Islands, the
Federated States of Micronesia, the Republic of the Marshall Islands,
the Republic of Palau)
10. Region X--Seattle (Alaska, Idaho, Oregon, Washington)
Section III. Functions
A. General Counsel and Immediate Office of the General Counsel
1. The General Counsel. The General Counsel is authorized to
promulgate such directives and issue such legal opinions as may be
necessary to carry out the responsibilities of the Office. The General
Counsel directly (or through attorneys in the Office of the General
Counsel), undertakes the following activities unless an applicable
statute provides otherwise or the General Counsel has delegated the
responsibility elsewhere:
a. Furnishes all legal services and advice to the Secretary, Deputy
Secretary, and all offices, branches, or units of the Department in
connection with the operations and administration of the Department and
its programs, except with respect to functions expressly delegated by
statute to the Inspector General.
b. Furnishes legal services and advice on such other matters as may
be submitted by the Secretary, the Deputy Secretary, any other senior
leaders, and other persons authorized by the Secretary to request such
service or advice.
c. Represents the Department in all litigation when such direct
representation is not precluded by law, and in other cases, making and
supervising all contacts with attorneys responsible for the conduct of
such litigation.
d. Acts as the Department's sole representative in communicating
with the Department of Justice, including all United States Attorneys,
on all civil matters and on all criminal matters, other than those
criminal matters referred to the Department of Justice by the Inspector
General.
e. Acts as the Department's sole representative in communicating
with Office of White House Counsel or the Offices of General Counsel
for any other Department or Agency.
f. Performs all liaison functions in connection with legal matters
involving the Department, and formulating or reviewing requests for
formal opinions or rulings by the Attorney General and the Comptroller
General.
g. Issues pre-enforcement rulings or advisory opinions to the
public on questions of law, except to the extent that that such
authority has previously been delegated to the Inspector General under
section 1128D of the Social Security Act.
h. Authorizes indemnification, as appropriate, pursuant to 45 CFR
part 36.
i. Conducts internal investigations at the request of the Secretary
or Deputy Secretary, or for matters that could lead to litigation.
j. Drafts all proposals for legislation originating in the
Department and reviewing all proposed legislation submitted to the
Department or to any operating agency of the Department for comment;
preparing reports and letters to congressional committees, the Office
of Management and Budget, and others on proposed legislation; and
prescribing procedures to govern the routing and review, within the
Department, of material relating to proposed Federal legislation.
k. Performs liaison functions with the Office of the Federal
Register, National Archives and Records Service.
l. Reviews and approves all administrative complaints and
enforcement actions by any agency within the Department before those
complaints are filed or transmitted, or enforcement actions instituted
to ensure that the complaint or enforcement action is legally sound.
m. Leads all negotiations on behalf of any agency within the
Department.
n. Supervises all legal activities of the Department and its
operating agencies.
o. Ensures that no one in the Department, other than those in OGC
or expressly authorized by statute to do so, provides any legal advice
to anyone in the Department or uses any title that
[[Page 54584]]
implies that they are functioning as a departmental lawyer.
2. Principal Deputy General Counsel. The Principal Deputy General
Counsel is the second ranking legal officer in the Department and
performs the functions of the General Counsel in his or her absence or
disability, including recusal, and, unless otherwise noted, oversees
for the General Counsel all litigation involving the Department, its
officers, inferior officers, and employees.
3. Deputy General Counsel. The Deputy General Counsel assist the
General Counsel in carrying out his or her responsibilities and
performs such duties as the General Counsel or Principal Deputy General
Counsel may assign. The Associate General Counsel for a Division shall
report to the General Counsel through one or more Deputy General
Counsel, as may be assigned by the General Counsel. Regional Chief
Counsel shall report to the General Counsel through a career Deputy
General Counsel.
B. Functions, Authorities and Responsibilities of the Divisions
The Divisions within OGC provide legal counsel to their clients, as
described below, subject to the professional supervision and control of
the General Counsel and assigned Deputy General Counsel.
1. General Law Division. The General Law Division, acting through
its Associate General Counsel, performs the following:
a. Provides legal services on business management activities and
administrative operations throughout the Department, including
employment, compensation, personnel, appropriations, real and personal
property (including National Environmental Policy Act), procurement,
information, travel, and certain claims by and against the Department.
b. Represents the Department in all aspects of administrative
litigation before the Merit Systems Protection Board (MSPB), Equal
Employment Opportunity Commission (EEOC), and in labor arbitrations, as
needed. Acts as agency counsel in support of the Department of Justice
on employment cases filed in federal court.
c. Represents the Department in bid protests filed before the
Comptroller General and contract disputes filed before the Civilian
Board of Contract Appeals. Acts as agency counsel in support of the
Department of Justice in bid protests and contract disputes filed
before the U.S. Court of Federal Claims and appealed to the Federal
Circuit.
d. Provides legal services to Department Freedom of Information Act
(FOIA) Officers on the disclosure of agency records requested under
FOIA, and communicates with the Department of Justice on the
administration of the Freedom of Information Act.
e. Provides legal services to the Department on the Privacy Act of
1974, as amended, the Paperwork Reduction Act, the Federal Records Act,
and the Government in the Sunshine Act.
f. Provides all legal services with respect to the formation,
maintenance, and administration of the advisory committees under the
Federal Advisory Committee Act.
g. Acts as the Department Claims Officer, responsible for
adjudicating all administrative claims filed under the Federal Tort
Claims Act, approval of claims filed under the Federal Medicare
Recovery Claims Act in amounts of at least $20,000 but not exceeding
$300,000, tort liability claims under the U.S. Constitution and other
laws under which claims for money damages may be filed with the
Department, as provided by 5 U.S.C. 5584, 10 U.S.C. 2774, except for
claims arising under the Social Security Act. Also responsible for
making final determinations on legally enforceable non tax debts owed
to the United States government arising from HHS programs under the
Federal Claims Collection Act, as amended, 31 U.S.C. 3711 et seq., on
the compromise of, and the suspension or termination of collection
activities for, claims in amounts of $100,000 or less, exclusive of
interest, and on the waiver of interest.
2. Children, Families, and Aging Division. The Children, Families,
and Aging Division Provides legal services to the Administration for
Children and Families and its various agencies including the Office of
Refugee Resettlement and Administration for Community Living.
3. Ethics Division. The Ethics Division administers and oversees
Department-wide implementation of comprehensive government ethics
program requirements under the Ethics in Government Act of 1978, as
amended, Executive Order 12731, and implementing regulations at 5 CFR
part 2638. The Division, without limitation, performs the following:
a. Provides legal advice and policy guidance on interpretation and
compliance issues involving the criminal conflict of interest statutes,
18 U.S.C. 210-219, political activity restrictions, anti-lobbying
provisions, outside activity limitations, travel reimbursement
guidelines, procurement integrity rules, financial disclosure
obligations, and standards of ethical conduct matters including gifts
between employees and from outside sources, conflicting financial
interests and impartiality concerns, misuse of position and agency
resources, and outside employment, fundraising, testimony, and
teaching, speaking or writing, to Department officials, agency
personnel, advisory committees and others.
b. Reviews executive branch public financial disclosure reports
submitted by Presidential nominees/appointees subject to Senate
confirmation, non-career SES and Schedule C political appointees, OGC
career SES officials, and Op/Staff Division ethics officials (DECs) to
assess potential violations of applicable laws or regulations, ensure
transparency through accurate reporting, provide counseling on the
avoidance of conflicts, and, if necessary, recommending appropriate
corrective action, including drafting waivers, disqualification
statements, ethics agreements, and certificate of divestiture
materials; ensuring identical review and counseling responsibilities
with respect to both the public and confidential financial disclosure
forms filed by career employees are performed Department-wide by the
DECs.
c. Plans, develops, and provides initial ethics orientation for new
employees, annual ethics training for employees who file financial
disclosure forms and others occupying certain sensitive positions,
initial and annual ethics training for members of federal advisory
committees, and specialized, topic-specific training on post-employment
restrictions, political activity restrictions, insider trading, and
procurement integrity rules.
d. Monitors component ethics programs and reviewing compliance with
core ethics program elements, including advice, financial disclosure,
outside activities, conflict of interest waivers, ethics agreements and
travel payments from non-federal sources.
e. Communicates on matters related to government ethics with the
Office of Counsel to the President, the Office of Government Ethics,
the Office of Special Counsel, the Office of the Inspector General,
Special Investigations Unit, the Office of Personnel Management, and
the General Services Administration.
f. Develops component-specific conduct regulations and implementing
procedures.
4. Food and Drug Division. The Food and Drug Division acts as the
Commissioner's legal advisor and provides legal services to FDA. FDD,
for example, performs the following:
[[Page 54585]]
a. Represents the FDA in connection with judicial and
administrative proceedings involving programs administered by the FDA.
Provides legal advice and policy guidance for programs administered by
the FDA.
b. Acts as the Department and FDA's sole liaison to the Department
of Justice and other Federal Departments for programs administered by
FDA; all criminal prosecutions, investigations, and civil matters may
only be referred to the Department of Justice through the Chief
Counsel.
c. Drafts or reviews all proposed and final regulations and Federal
Register notices prepared by FDA.
d. Performs legal research and gives legal opinions on regulatory
issues, actions, and petitions submitted to FDA.
e. Reviews proposed legislation affecting FDA that originates in
the Department or on which Congress requests the views of the
Department.
f. Provides legal advice and assistance to the Office of the
Secretary on matters within the expertise of the Chief Counsel.
5. Public Health Division. The Public Health Division provides
legal services to all Public Health Service agencies (except to the
Food and Drug Administration) and their programs, including the Office
of the Surgeon General and the Commissioned Corps of the U.S. Public
Health Service. Represented Public Health Service agencies include, but
are not limited to the (i) the Office of the Assistant Secretary for
Health, and its various programs, (ii) the Office of the Secretary's
Office of Minority Health, (iii) the Centers for Disease Control and
Prevention, (iv) the National Institutes of Health, (v) the Health
Resources and Services Administration, (vi) the Indian Health Service,
(vii) the Substance Abuse and Mental Health Services Administration,
(viii) the Agency for Healthcare Research and Quality, and (ix) the
Office of the Assistant Secretary for Preparedness and Response. In
addition, the Public Health Service Division serves as the lead office
within the Office of the General Counsel for grants-related and
intellectual property issues, other than federal court or PTAB
litigation.
6. Legislation Division. The Legislation Division performs the
following:
a. Drafts all proposed legislation originating in the Department,
reviewing specifications for such proposed legislation, and reviewing
all proposed legislation submitted to the Department or to any
constituent unit of the Department for comment.
b. Prepares or reviews reports and letters to Congressional
Committees, the Office of Management and Budget, and others on proposed
legislation.
c. Reviews proposed testimony of Department officials before
Congressional Committees relating to pending or proposed legislation.
d. Acts as Department liaison with the Office of Management and
Budget on legislative matters.
e. Prescribes procedures to govern the routing and review, within
the Department, of material relating to proposed Federal legislation.
7. Centers for Medicare & Medicaid Services Division. The Centers
for Medicare & Medicaid Services Division, acting through the Deputy
General Counsel serving as the CMS Chief Legal Officer or an Associate
General Counsel,
a. Acts as the CMS Administrator's legal advisor.
b. Represents CMS and the Office of the National Coordinator for
Health Information Technology (``ONC'') in court proceedings and
administrative hearings with respect to programs administered by CMS or
ONC.
c. Provides legal advice and policy guidance for programs
administered by CMS and ONC.
d. Acts as the Department's and CMS's and ONC's liaison to the
Department of Justice and other Federal Departments for programs
administered by those operating divisions.
e. Drafts or reviews all proposed and final regulations and Federal
Register notices prepared by CMS, ONC, and other agencies.
f. Performs legal research and gives legal opinions on regulatory
issues, actions, and petitions submitted to CMS and ONC.
g. Reviews proposed legislation affecting CMS, ONC, Office of
Medicare Hearing Appeals (OMHA) and DAB that originates in the
Department or on which Congress requests the views of the Department.
h. Provides legal advice and assistance to the Office of the
Secretary on matters within the expertise of the CMS Chief Legal
Officer.
i. Provides legal advice and assistance to the Office of the
Secretary on matters relating to the COVID-19 Provider Relief Fund
(PRF) and similar provider relief programs, including advice regarding
the administration of the PRF, civil litigation relating to the PRF,
and fraud and abuse involving PRF payments.
8. Civil Rights Division. The Civil Rights Division provides legal
services for the Office for Civil Rights (OCR) and provides legal
advice with respect to the civil rights laws to all agencies and
offices within the Department, and in coordination with the assigned
Deputy General Counsel, evaluates complaints, advises whether there is
legal basis to proceed, assists OCR in developing and implementing
investigation plans, and clears the imposition of any civil money
penalties. CRD likewise represents the Department in administrative
proceedings and federal litigation, together with the Department of
Justice. CRD provides these legal services with respect to:
a. Traditional civil rights laws such as, by way of example, title
VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), title IX
of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age
Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), section 504 of the
Rehabilitation Act of 1973 (29 U.S.C. 794), the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101 et seq. and 47 U.S.C. 225,
661), section 1557 of the Affordable Care Act (42 U.S.C. 18116).
b. Conscience statutes, such as the Church Amendments, the Weldon
Amendment, and the Coats-Snowe Amendment.
c. The Health Insurance and Portability and Accountability Act of
1996 (Social Security Act section 1171 et seq.), the Health Information
Technology for Economic and Clinical Health (HITECH) Act, and the rules
implementing them.
The authorities of CRD and the General Counsel described here do
not supersede the terms of any statute, regulation, or delegation
granting authority or responsibility to OCR.
9. National Complex Litigation and Investigations Division. The
National Complex Litigation and Investigations Division provides legal
services across the Department, as directed by the General Counsel or
Principal Deputy General Counsel. In that regard, NCLID, performs the
following:
a. Coordinates litigation spanning multiple OGC divisions, regional
offices, or geographic areas.
b. Provides legal services in connection with complex litigation or
anticipated complex litigation by or against the Department. Such
litigation may include cases for which other OGC divisions or OGC
regions request NCLID participation; cases spanning multiple OGC
divisions or regional offices, or cases outside the scope of other OGC
divisions or regional offices.
c. Conducts internal investigations at the request of the Secretary
or Deputy Secretary, or on matters that could lead to litigation.
d. Administers the OGC-wide e-discovery program, and coordinates
the
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use of e-discovery technology with other HHS staff and operating
divisions.
e. Identifies and supports the implementation of best practices for
litigation management, e-discovery, and virtual staffing across OGC.
C. Functions, Authorities and Responsibilities of the Regions
The Chief Counsel of each Region is HHS' legal representative in
that Region. Regional offices within OGC provide a full range of legal
services including, by way of example, legal counsel to their
departmental clients and client agencies in the regions, as described
below, subject to the professional supervision and direction of the
General Counsel.
The Office of the General Counsel's ten regional offices provide
legal advice, administrative and judicial litigation support and
counseling services to the regional components of the Department.
Regional attorneys provide general law support to regional clients and
handle work in most areas within HHS' jurisdiction with particular
emphasis on litigation for, among others, CMS, ACF, OCR, CDC, and IHS.
Regional offices also provide leadership with respect to bankruptcy
cases. In the area of civil rights, they work in close consultation
with the Associate General Counsel for the Civil Rights Division to
ensure that the regional positions align closely with those of the
Division thereby fostering national uniformity. In other areas, the
Divisions and Regions work collaboratively to provide consistent,
uniform legal advice.
Dated: August 27, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-19325 Filed 8-28-20; 8:45 am]
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