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Cosmetic Act (the act) (21 U.S.C. Subpart L-Mammography Facili360aa(a)) and to designate such drug as ties; Redelegations of Authora drug for a rare disease or condition

ity under section 526(a) of the act (21 U.S.C. 360bb(a)).

85.1000 Authority to ensure that mam(2) To issue holders of approved appli- mography facilities meet quality cations or licenses notice and oppor

standards. tunity for the submission of views (a) The following officials are authorunder section 527(b)(1) of the act (921 ized to ensure mammography facilities U.S.C. 360cc(b)(1)).

obtain certificates under section 354(b) (3) To encourage sponsors of an inves- of the Public Health Service Act (the tigational new drug for a rare disease PHS Act) (42 U.S.C. 263b(b)): or condition to design protocols for

(1) The Director and Deputy Direcclinical investigations to permit the

tors for Science and for Regulations addition to the investigation of persons

and Policy, Center for Devices and Rawith the disease or condition under

diological Health (CDRH). section 528 of the act (21 U.S.C. 360dd).

(2) The Director and Deputy Director, (c) The following officials are author

Office of Health and Industry Programs

(OHIP), CDRH. ized to provide sponsors, under section 525(a) of the act (21 U.S.C. 360aa(a)),

(3) The Director and Deputy Director, with recommendations for nonclinical

Division of Mammography Quality and

Radiation Programs (DMQRP), OHIP, or clinical investigations believed to be

CDRH. necessary for a drug for a rare disease

(b) The following officials are authoror condition to be approved or licensed:

ized to issue, renew and extend certifi(1) For drugs under their jurisdiction:

cates to mammography facilities under (i) The Director, the Deputy Direc- section 354(c) of the PHS Act (42 U.S.C. tor, and the Directors, Office of Review 263b(c)): Management and Office of Pharma- (1) The Director and Deputy Direcceutical Science, Center for Drug Eval- tors for Science and for Regulations uation and Research (CDER).

and Policy, CDRH. (ii) The Directors and Deputy Direc- (2) The Director and Deputy Director, tors of the Offices of Drug Evaluation OHIP, CDRH. I, II, III, IV, and V, Office of Review (3) The Director and Deputy Director, Management, CDER.

DMQRP, OHIP, CDRH. (iii) The Directors and Deputy Direc- (c) The following officials are authortors of the divisions in the Offices of ized to accept an application for a cerDrug Evaluation I, II, III, IV, and V,

tificate under section 354(d)(1) of the Office of Review Management, CDER.

PHS Act (42 U.S.C. 263b(d)(1)): (2) For biological products under

(1) The Director and Deputy Directheir jurisdiction:

tors for Science and for Regulations (i) The Director and Deputy Direc

and Policy, CDRH. tors, Center for Biologics Evaluation

(2) The Director and Deputy Director, and Research (CBER).

OHIP, CDRH.

(3) The Director and Deputy Director, (ii) The Directors and Deputy Direc

DMQRP, OHIP, CDRH. tors, Office of Blood Research and Re

(d) The following officials are authorview (OBRR), Office of Vaccines Re

ized to approve accreditation bodies to search and Review (OVRR), Office of

accredit mammography facilities under Therapeutics Research and Review

section 354(e)(1)(A) of the PHS Act (42 (OTRR), CBER.

U.S.C. 263b(e)(1)(A)): (iii) The Directors and Deputy Direc- (1) The Director and Deputy Directors of the Divisions in OBRR, OVRR, tors for Science and for Regulations and OTRR, CBER.

and Policy, CDRH. (d) These officials may not further (2) The Director and Deputy Director, redelegate these authorities.

OHIP, CDRH.

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(e) The following officials are authorized to ensure accreditation bodies provide satisfactory assurances of compliance under section 354(e)(1)(C) of the PHS Act (42 U.S.C. 263b(e)(1)(c)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(f) The Director, CDRH is authorized to issue regulations under which the Director may withdraw approval of accreditation bodies under section 354(e)(2)(A) of the PHS Act (42 U.S.C. 263b(e)(2)(A)).

(g) The following officials are authorized to determine the expiration date of a certificate of a facility accredited by an accreditation body after the body's approval is withdrawn, or State's certification authority has been withdrawn, or a facility's accreditation has been revoked by an accreditation body under sections 354(e)(2)(B) and 354(e)(5) of the PHS Act (42 U.S.C. 263b(e)(2)(B) and (e)(5)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(h) The following officials are authorized to determine the applicable standards for a facility for accreditation under section 354(e)(3) of the PHS Act (42 U.S.C. 263b(e)(3)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(i) The following officials are authorized to ensure accreditation bodies make on site visits and to determine whether other measures appropriate under section 354(e)(4) of the PHS Act (42 U.S.C. 263b(e)(4)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(j) The following officials are authorized to evaluate annually the performance of each approved accreditation body as provided by section 354(e)(6)(A) of the PHS Act (41 U.S.C. 263b(e)(6)(A)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(k) The following officials are thorized to determine the compliance of certified facilities with established standards through annual facility inspections as provided by section 354(g) of the PHS Act (42 U.S.C. 263b(g)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(1) The following officials are authorized to promote voluntary compliance with established standards instead of taking actions under section 354(i) of the PHS Act (42 U.S.C. 263b(i)) by imposing directed plans of correction and or payment of the cost of onsite monitoring under section 354(h)(1) of the PHS Act (42 U.S.C. 263b(h)(1)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(m) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH are authorized to impose sanctions under section 354(h)(2) of the PHS Act (42 U.S.C. 263b(h)(2)).

(n) The following officials are authorized to develop and implement the procedures for determining when and how to impose sanctions as provided by section 354(h)(3) of the PHS Act (42 U.S.C. 263b(h)(3)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

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tions 354(q)(1) and (q)(2) of the PHS Act (42 U.S.C. 263b(g)(1) and (g)(2)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(t) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH are authorized, after providing notice and opportunity for corrective action, to withdraw the approval of a State's authority to carry out certification requirements and implement quality standards under section 354(q)(4) of the PHS Act (42 U.S.C. 263b(g)(4)).

(u) These officials may not further redelegate these authorities.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(0) The following officials are authorized to suspend or revoke individual facility certificates under section 354(i)(1) and (i)(2) of the PHS Act (42 U.S.C. 263b(i)(1) and (i)(2)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(p) The following officials are authorized under section 354(1)(3) of the PHS Act (42 U.S.C. 263b(i)(3)) to ensure that no person who owned or operated a facility at the time the cause of revocation occurred may, within 2 years of the revocation of the certificate, own or operate a mammography facility:

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(q) The following officials are authorized to compile and make available to physicians and the general public information determined to be useful in evaluating the performance of mammography facilities as provided by section 354(1) of the PHS Act (42 U.S.C. 2635(1):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP, CDRH.

(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(r) The following officials are authorized to ensure that appropriate Federal agencies are consulted in the development of standards, regulations, evaluations, procedures for compliance and oversight as provided by section 354(0) of the PHS Act (42 U.S.C. 263b(o)):

(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

(2) The Director and Deputy Director, OHIP,

CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH.

(s) The following officials may authorize a State to carry out certification program requirements and implement quality standards under sec

Subpart M-Organization $ 5.1100 Headquarters.

The central organization of the Food and Drug Administration consists of the following: OFFICE OF THE COMMISSIONER.1 Office of the Chief Counsel. Office of Equal Opportunity. Office of the Administrative Law Judge. Office of the Senior Associate Commissioner. Office of Executive Secretariat. Office of Public Affairs. Office of the Ombudsman. Office of Orphan Products Development. Office of Internal Affairs. Office of Executive Operations. Office of Science Coordination and Communication. Office of Human Research Trials. Office of International and Constituent Relations. Office of International Programs. Office of Consumer Affairs. Office of Women's Health. Office of Special Health Issues. Office of Policy, Planning, and Legislation. Office of Policy.

1 Mailing address: 5600 Fishers Lane, Rockville, MD 20857.

Office of Planning.
Office of Legislation.
Office of Management and Systems.
Office of Human Resources and Man-
agement Services.
Office of Information Resources Man-
agement.
Office of Financial Management.
Office of Facilities, Acquisitions, and
Central Services.2
CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH.3
Office of the Center Director.
Scientific Advisors and Consultants
Staff.
Equal Employment Opportunity and
Workforce Diversity Staff.
Quality Assurance Staff.
Regulations and Policy Staff.
Veterinary Services Staff.
Office of Management.
Regulatory Information Management
Staff.
Division of Planning, Evaluation, and
Budget.
Division of Management Services.
Office of Information Technology Man-
agement.
Division of Information Technology
Operations.
Division of Information Technology
Development.
Division of Information Technology In-
frastructure.
Office of Compliance and Biologics Qual-
ity.
Division of Case Management.
Division of Manufacturing and Product
Quality.
Division of Inspections and Surveil-
lance.
Office of Blood Research and Review.
Human Tissue Staff.
Policy and Publications Staff.
Division of Emerging and Transfusion
Transmitted Diseases.
Division of Hematology.
Division of Blood Applications.

Office of Therapeutics Research and Re-
view.
Division of Cellular and Gene Thera-
pies.
Division of Therapeutic Proteins.
Division of Monoclonal Antibodies.
Division of Clinical Trial Design and
Analysis.
Division of Application Review and
Policy.
Office of Vaccines Research and Review.
Division of Bacterial, Parasitic, and
Allergenic Products.
Division of Viral Products.
Division of Vaccines and Related Prod-
ucts Applications.
Office of Communication, Training, and
Manufacturers Assistance.
Division of Disclosure and Oversight
Management.
Division of Manufacturers Assistance
and Training.
Division of Communication and Con-
sumer Affairs.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
CENTER FOR FOOD SAFETY AND APPLIED
NUTRITION.4
Office of the Center Director.
Food Safety Initiatives Staff.
Office of Science
Quality Assurance Staff.
CFSAN Staff College.
Microbial Research and Risk Assess-
ment Staff.
JIFSAN Liaison Staff.
CFSAN Food Advisory Committee
Staff.
Office of Applied Research and Safety As-
sessment.
Muirkirk Technical Operations Staff.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology and Nutritional
Product Studies.
Division of In Vitro and Biochemical
Toxicology.
Office of Regulations and Policy.

2 Mailing address: 5630 Fishers Lane, Rockville, MD 20857.

3 Mailing address: 1401 Rockville Pike, Rockville, MD 20852–1448.

Mailing address: 5100 Paint Branch Pkwy., College Park, MD 20740.

Regulations Coordination Staff.
Office of Constituent Operations.
Consumer Education Staff.
Industry Activities Staff.
International Activities Staff.
Office of Management Systems.
Safety Management Systems.
Division of Information Resources
Management.
Division of Planning and Financial Re-
sources Management.
Division of Management Operations.
Division of Administrative Services
Management.
Office of Operations.
Equal Employment Opportunity Staff.
Executive Operations Staff.
Office of Cosmetics and Colors.
Division of Programs and Enforcement
Policy.
Division of Science and Applied Tech-
nology.
Office of Nutritional Products, Labeling
and Dietary Supplements.
Division of Compliance and Enforce-
ment.
Division of Standards and Labeling
Regulations.
Division of Nutrition Science Policy.
Office of Premarket Approval.
Division of Product Policy.
Division of Petition Control.
Division of Health Effects Evaluation.
Division of Product Manufacture and
Use.
Office of Plant and Dairy Foods and Bev-
erages.
Division of Pesticides and Industrial
Chemicals.
Division of Natural Products.
Division of Food Processing and Pack-
aging.
Division of Plant Product Safety.
Division of Dairy and Egg Safety.
Division of Risk Assessment.
Division of Microbiological Studies.
Office of Seafood.
Division of Special Programs.
Division of Programs and Enforcement
Policy.

Division of Science and Applied Tech-
nology.
Office of Field Programs.
Division of Enforcement and Programs.
Division of HACCP Programs.
Division of Cooperative Programs.
Office of Scientific Analysis and Support.
Division of General Scientific Support.
Division of Mathematics.
Division of Market Studies.
CENTER FOR DRUG EVALUATION AND RE-
SEARCH.1
Office of the Center Director.
Equal Employment Opportunity Staff.
Executive Operations Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Information Disclosure Pol-
icy.
Office of Management.1
Strategic Planning Staff.1
Division of Management and Budget.5
Division of Management Services.1
Office of Training and Communication. 1
Medwatch Staff.
Division of Library and Information
Services.
Division of Training and Development.
Division of Public Affairs.
Division of Drug Information.
Office of Compliance.6
Division of Manufacturing and Product
Quality.
Division of Prescription Drug Compli-
ance and Surveillance.
Division of Labeling and Non-Prescrip-
tion Drug Compliance.
Office of Information Technology.1
Quality Assurance Staff.
Technology Support Services Staff.
Division of Data Management and
Services.
Division of Applications Development
and Services.
Division of Infrastructure Management
and Services.

5 Mailing address: 7500 Standish Pl., Rockville, MD 20855.

6 Mailing address: 7520 Standish Pl., Rockville, MD 20855.

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