Cosmetic Act Act (the act) (21 U.S.C. 360aa(a)) and to designate such drug as a drug for a rare disease or condition under section 526(a) of the act (21 U.S.C. 360bb(a)). (2) To issue holders of approved applications or licenses notice and opportunity for the submission of views under section 527(b)(1) of the act (921 U.S.C. 360cc(b)(1)). (3) To encourage sponsors of an investigational new drug for a rare disease or condition to design protocols for clinical investigations to permit the addition to the investigation of persons with the disease or condition under section 528 of the act (21 U.S.C. 360dd). (c) The following officials are authorized to provide sponsors, under section 525(a) of the act (21 U.S.C. 360aa(a)), with recommendations for nonclinical or clinical investigations believed to be necessary for a drug for a rare disease or condition to be approved or licensed: (1) For drugs under their jurisdiction: (i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (2) For biological products under their jurisdiction: (i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), Office of Therapeutics Research and Review (OTRR), CBER. (iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER. (d) These officials may not further redelegate these authorities. Subpart L-Mammography Facilities; Redelegations of Authority § 5.1000 Authority to ensure that mammography facilities meet quality standards. (a) The following officials are authorized to ensure mammography facilities obtain certificates under section 354(b) of the Public Health Service Act (the PHS Act) (42 U.S.C. 263b(b)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Health and Industry Programs (OHIP), CDRH. (3) The Director and Deputy Director, Division of Mammography Quality and Radiation Programs (DMQRP), OHIP, CDRH. (b) The following officials are authorized to issue, renew and extend certificates to mammography facilities under section 354(c) of the PHS Act (42 U.S.C. 263b(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. (c) The following officials are authorized to accept an application for a certificate under section 354(d)(1) of the PHS Act (42 U.S.C. 263b(d)(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. (d) The following officials are authorized to approve accreditation bodies to accredit mammography facilities under section 354(e)(1)(A) of the PHS Act (42 U.S.C. 263b(e)(1)(A)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (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 a 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 are 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 authorized 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. (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(i)(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. 263b(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 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. 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 the Administrative Law Office of the Senior Associate Commissioner. Office of Executive Secretariat. Office of the Ombudsman. Office of Orphan Products Development. Office of Internal Affairs. Office of Executive Operations. Office of Science Coordination and Office of Human Research Trials. Office of International Programs. Office of Special Health Issues. Office of Policy. 1 Mailing address: 5600 Fishers Lane, Rockville, MD 20857. Regulations and Policy Staff. Veterinary Services Staff. Regulatory Information Management Division of Planning, Evaluation, and Budget. Division of Management Services. Office of Information Technology Management. Division of Information Technology Operations. Division of Information Technology Development. Division of Information Technology Infrastructure. Office of Compliance and Biologics Quality. Division of Case Management. Division of Manufacturing and Product Quality. Division of Inspections and Surveillance. Office of Blood Research and Review. Policy and Publications Staff. Division of Emerging and Transfusion Transmitted Diseases. Division of Hematology. Division of Blood Applications. 2 Mailing address: 5630 Fishers Lane, Rockville, MD 20857. 3 Mailing address: 1401 Rockville Pike, Rockville, MD 20852-1448. Office of Therapeutics Research and Review. Division of Cellular and Gene Therapies. 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 Products Applications. Office of Communication, Training, and Manufacturers Assistance. Division of Disclosure and Oversight Management. Division of Manufacturers Assistance and Training. Division of Communication and Consumer 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 Assessment Staff. JIFSAN Liaison Staff. Office of Operations. Equal Employment Opportunity Staff. Division of Programs and Enforcement Division of Science and Applied Technology. Office of Nutritional Products, Labeling and Dietary Supplements. Division of Compliance and Enforcement. Division of Standards and Labeling Division of Nutrition Science Policy. Office of Plant and Dairy Foods and Beverages. Division of Pesticides and Industrial Chemicals. Division of Natural Products. Division of Food Processing and Packaging. Division of Plant Product Safety. Division of Risk Assessment. Division of Special Programs. Division of Programs and Enforcement Policy. Division of Science and Applied Technology. Office of Field Programs. Division of Enforcement and Programs. Division of Market Studies. CENTER FOR DRUG EVALUATION AND RESEARCH.1 Office of the Center Director. Equal Employment Opportunity Staff. Division of Regulatory Policy II. Division of Information Disclosure Policy. Office of Management.1 Strategic Planning Staff.1 Division of Management and Budget.5 Office of Training and Communication.1 Division of Library and Information Services. Division of Training and Development. Division of Drug Information. Division of Manufacturing and Product Division of Prescription Drug Compliance and Surveillance. Division of Labeling and Non-Prescription 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. |