[Federal Register Volume 69, Number 64 (Friday, April 2, 2004)]
[Rules and Regulations]
[Pages 17285-17296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7398]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0142]

21 CFR Chapter I


Removal of Delegations of Authority and Conforming Changes to 
Regulations

Agency: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this final 
rule to amend the regulations by removing the delegations of authority, 
to update the regulations to reflect the agency's organization, and to 
make other conforming changes. Because FDA makes information on 
delegations of authority available on FDA's Internet Web site, the 
regulations on delegations of authority are no longer necessary. The 
availability of the information on delegations of authority through the 
agency's Web site provides the public with more current and up-to-date 
information.

DATES: This rule is effective April 2, 2004.

FOR FURTHER INFORMATION CONTACT: Donna G. Page, Management Programs and 
Analysis Branch (HFA-340), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-4816; or
    Rudy Guillen, Management Programs and Analysis Branch (HFA-340), 
5600 Fishers Lane, Rockville, MD 20857, 301-827-4806.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this final rule to amend its regulations by removing 
the delegations of authority previously published in part 5 (21 CFR 
part 5) and to update the organizational information in part 5. The 
delegation of authority information is now available on the Internet at 
http://www.fda.gov/smg/default.htm. Attached to this final rule is an 
appendix that cross-references the previously used CFR citations to the 
Internet-based system. The agency last updated part 5 in a final rule 
published on June 8, 2001 (66 FR 30992). In the preamble of that final 
rule, FDA stated its plan to move to an Internet-based system and 
remove the delegations of authority from part 5. The use of an 
Internet-based system allows FDA to provide more current and up-to-date 
information to the public on delegations of authority.
    The agency has also made conforming changes to several other parts 
to remove the references to the delegations of authority in part 5 and 
to make other conforming changes. The agency has made these changes to 
the following regulations: 21 CFR 7.45(a), 10.1(a), 10.3(a), 16.26(a), 
16.40, 25.5(b)(5), 25.40(e), 25.45(a), 500.80(a), and 1002.3. 
Additionally, the agency has updated the references to part 5, subpart 
M in the following regulations: 21 CFR 21.43(a)(2), 106.120(b), 
107.50(e)(2), 107.230(e), 107.240(b) and (c)(1), 107.250, 203.11(a), 
and 800.55(g)(4).
    The portion of this final rule removing the part 5 delegations of 
authority and updating the organizational information in part 5, 
subpart M is a rule of agency organization, procedure, or practice. FDA 
is issuing these provisions as a

[[Page 17286]]

final rule without publishing a general notice of proposed rulemaking 
because such notice is not required for rules of agency organization, 
procedure, or practice under 5 U.S.C. 553(b)(3)(A). For the conforming 
changes to the other regulations, the agency finds good cause under 5 
U.S.C. 553(b)(3)(B) to dispense with prior notice and comment, and good 
cause under 5 U.S.C. 553(d)(3) to make these conforming changes 
effective less than 30 days after publication because such notice and 
comment and delayed effective date are unnecessary and contrary to the 
public interest. As discussed previously, these conforming changes 
merely remove references to part 5, update the references to part 5, 
subpart M, and make other minor conforming changes. These changes do 
not result in any substantive change to the regulations.

II. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the principles identified in the 
Executive order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive order and so is not 
subject to review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule simply removes the part 5 
delegations of authority, updates the organizational information, and 
makes conforming changes to other regulations, it does not impose any 
additional costs on industry. Consequently, the agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement of anticipated costs and 
benefits before proposing any rule that may result in an expenditure 
year by State, local, and tribal governments, in the aggregate, or by 
the private sector, of $100 million or more in any one year (adjusted 
annually for inflation). The current threshold after adjustment for 
inflation is $112.3 million. As stated previously, this final rule does 
not impose any additional costs on industry. Therefore, this final rule 
will not result in any 1-year expenditure that would meet or exceed 
this amount.

III. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

IV. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have significant effect 
on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly the agency has concluded that 
the rule does not contain policies that have federalism implications as 
defined in the Executive order and, consequently, a federalism summary 
impact statement is not required.

List of Subjects

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 7

    Administrative practice and procedure, Consumer protection, 
Reporting and recordkeeping requirements.

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 21

    Privacy.

21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and 
recordkeeping requirements.

21 CFR Part 106

    Food grades and standards, Infants and children, Nutrition, 
Reporting and recordkeeping requirements.

21 CFR Part 107

    Food labeling, Infants and children, Nutrition, Reporting and 
recordkeeping requirements, Signs and symbols.

21 CFR Part 203

    Labeling, Prescription drugs, Reporting and recordkeeping 
requirements, Warehouses.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCBs).

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority of the Commissioner of Food and Drugs, 21 CFR Chapter I is 
amended as follows:

0
1. Part 5 is revised in its entirety to read as follows:

PART 5--ORGANIZATION

Subparts A-L--[Reserved]

Subpart M--Organization

Sec
5.1100 Headquarters.
5.1105 Chief Counsel, Food and Drug Administration.
5.1110 FDA Public Information Offices.

    Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.

Subparts A-L--[Reserved]

Subpart M--Organization


Sec.  5.1100  Headquarters.

    The central organization of the Food and Drug Administration 
consists of the following:

[[Page 17287]]

OFFICE OF THE COMMISSIONER.\1\
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    \1\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
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Office of the Chief Counsel.\2\
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    \2\ The Office of the Chief Counsel (also known as the Food and 
Drug Division, Office of the General Counsel, Department of Health 
and Human Services), while administratively within the Office of the 
Commissioner, is part of the Office of the General Counsel of the 
Department of Health and Human Services.
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Office of Equal Employment Opportunity and Diversity.
Office of the Administrative Law Judge.
Office of External Relations.
Office of Executive Secretariat.
Office of Public Affairs.
Office of the Ombudsman.
Office of Special Health Issues.
Office of Policy and Planning.
Office of Policy.
Office of Planning.
Office of Management.
Office of the Chief Information Officer.
Office of Financial Management.
Office of Shared Services.\3\
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    \3\ Mailing address: 5630 Fishers Lane, Rockville, MD 20852.
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Office of Management Programs.
Office of Executive Operations.
Office of Science and Health Coordination.
Office of Orphan Products Development.
Office of Women's Health.
Office of International Activities and Strategic Initiatives.
Office of International Programs.
Office of Pediatric Therapeutics.
Office of Combination Products.
Office of Legislation.
Office of Crisis Management.
Office of Emergency Operations.
Office of Security Operations, Policy and Planning.
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.\4\
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    \4\ Mailing address: 1401 Rockville Pike, Rockville, MD 20852-
1448.
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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 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.
Office of Vaccines Research and Review.
Analytical Chemistry Staff.
Standards and Testing Staff.
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.
Office of Information Management.
Division of Information Operations.
Division of Information Development.
Office of Cellular, Tissue, and Gene Therapies.
Division of Cell and Gene Therapies.
Division of Clinical Evaluation and Pharmacology/Toxicology Review.
Division of Human Tissues.
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION.\5\
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    \5\ Mailing address: 5100 Paint Branch Pkwy., College Park, MD 
20740-3835.
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Office of the Center Director.
Food Safety Staff.
Office of Science.
Quality Assurance Staff.
CFSAN Staff College.
Microbial Research and Risk Assessment Staff.
JIFSAN Liaison Staff.
CFSAN Food Advisory Committee Staff.
Office of Applied Research and Safety Assessment.
Muirkirk Technical Operations Staff.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology.
Office of Regulations and Policy.
Regulations Management Staff.
Office of Constituent Operations.
Consumer Education Staff.
International Activities Staff.
Industry Activities Staff.
Office of Management Systems.
Safety Management Staff.
Division of Information Resources Management.
Division of Planning and Financial Resources Management.
Division of Program Support Services.
Office of Operations.
Equal Employment Opportunity Staff.
Executive Operations Staff.
Office of Cosmetics and Colors.
Division of Color Certification and Technology.
Division of Cosmetics and Compliance.
Office of Nutritional Products, Labeling and Dietary Supplements.
Infant Formula and Medical Foods Staff.
Division of Dietary Supplement Programs and Compliance.
Division of Food Labeling, Standards and Compliance.
Division of Nutrition Programs and Labeling.
Division of Research and Applied Technology.
Office of Food Additive Safety.
Division of Petition Review.
Division of Chemistry Research and Environmental Review.
Division of Food Contact Notifications.
Division of Biotechnology and GRAS Notice Review.
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 Dairy and Egg Safety.
Division of Risk Assessment.
Division of Microbiological Studies.
Office of Seafood.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Compliance.
Emergency Coordination and Response Staff.
Division of Enforcement.
Division of Field Programs.

[[Page 17288]]

Division of Cooperative Programs.
Office of Scientific Analysis and Support.
CFSAN Adverse Events Reporting System Staff.
Division of General Scientific Support.
Division of Mathematics.
Division of Market Studies.
CENTER FOR DRUG EVALUATION AND RESEARCH.\1\
Office of the Center Director.
Equal Employment Opportunity Staff.
Controlled Substance Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Information Disclosure Policy.
Office of Management.\1\
Division of Management and Budget.\1\
Division of Management Services.\1\
Office of Training and Communication.\1\
Division of Training and Development.
Division of Public Affairs.
Division of Drug Information.
Division of Library and Information Services.
Office of Compliance.\1\
Division of Compliance Risk Management and Surveillance.
Division of New Drugs and Labeling Compliance.
Division of Manufacturing and Product Quality.
Office of Information Technology.\1\
Quality Assurance Staff.
Technology Support Services Staff.
Division of Applications Development and Services.
Division of Infrastructure Management and Services.
Office of Medical Policy.\1\
Division of Drug Marketing, Advertising and Communication.\1\
Division of Scientific Investigations.\6\
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    \6\ Mailing address: 7520 Standish Pl., Rockville, MD 20855.
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Office of Pharmacoepidemiology and Statistical Science.
Office of Drug Safety.
Division of Surveillance, Research and Communication Support.
Division of Medication Errors and Technical Support.
Division of Drug Risk Evaluation.
Office of Biostatistics.
Quantitative Methods and Research Staff.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Office of Executive Programs.
Executive Operations Staff.
Quality Assurance Staff.
Advisors and Consultants Staff.\2\
Office of Counter-Terrorism and Pediatric Drug Development.
Division of Counter-Terrorism.
Division of Pediatric Drug Development.
Office of Information Management.
Business Information Staff.
Review Technology Staff.
Division of Records Management.
Office of New Drugs.\1\
Office of Drug Evaluation I.\1\
Division of Cardio-Renal Drug Products.
Division of Neuropharmacological Drug Products.
Division of Oncology Drug Products.
Office of Drug Evaluation II.\1\
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary and Allergy Drug Products.
Division of Anesthetic, Critical Care and Addiction Drug Products.
Office of Drug Evaluation III.\1\
Division of Gastrointestinal and Coagulation Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.
Division of Reproductive and Urologic Drug Products.
Office of Drug Evaluation IV. \1\
Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.
Division of Special Pathogen and Immunologic Drug Products.
Office of Drug Evaluation V.
Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug 
Products.
Division of Dermatologic and Dental Drug Products.
Division of Over-The-Counter Drug Products.
Office of Drug Evaluation VI.
Division of Therapeutic Biological Oncology Products.
Division of Therapeutic Biological Internal Medicine Products.
Division of Review Management and Policy.
Office of Pharmaceutical Science.\1\
Quality Implementation Staff.\1\
Operations Staff.\1\
Informatics and Computational Safety Analysis Staff.
Office of Clinical Pharmacology and Biopharmaceutics.
Pharmacometrics Staff.
Division of Pharmaceutical Evaluation I.\1\
Division of Pharmaceutical Evaluation II.\1\
Division of Pharmaceutical Evaluation III.\1\
Office of Generic Drugs.\6\
Division of Bioequivalence.
Division of Chemistry I.
Division of Chemistry II.
Division of Labeling and Program Support.
Division of Chemistry III.
Office of New Drug Chemistry.\1\
Division of New Drug Chemistry I.\1\
Division of New Drug Chemistry II.\1\
Division of New Drug Chemistry III.\1\
Office of Testing and Research.\1\
Laboratory of Clinical Pharmacology.\7\
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    \7\ Mailing address: Four Research Ct., Rockville, MD 20850.
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Division of Applied Pharmacology Research.\8\
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    \8\ Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708.
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Division of Pharmaceutical Analysis.\9\
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    \9\ Mailing address: 1114 Market St., St. Louis, MO 63101.
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Division of Product Quality Research.\1\
Office of Biotechnology Products.
Division of Monoclonal Antibodies.
Division of Therapeutic Protein.
OFFICE OF REGULATORY AFFAIRS.\1\
Equal Employment Opportunity Staff.
Office of Resource Management.
Strategic Initiatives Staff.
Division of Planning, Evaluation, and Management.
Division of Human Resource Development.
Division of Management Operations.
Division of Personnel Operations.
Office of Information Technology.
Office of Enforcement.
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Compliance Information and Quality Assurance.
Office of Regional Operations.
Division of Federal-State Relations.
Division of Field Science.
Division of Import Operations and Policy.
Division of Field Investigations.
Office of Criminal Investigations.
Office of Internal Affairs.
Mid-Atlantic Area Office.\10\
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    \10\ Mailing address: 900 U.S. Customhouse, Second Chestnut St., 
Philadelphia, PA 19106.

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[[Page 17289]]

Midwest Area Office.\11\
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    \11\ Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 
60532.
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Northeast Area Office.\12\
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    \12\ Mailing address: 850 Third Ave., Brooklyn, NY 11232.
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Pacific Area Office.\13\
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    \13\ Mailing address: 13301 Clay St., Oakland, CA 94512.
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Southeast Area Office.\14\
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    \14\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
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Southwest Area Office.\15\
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    \15\ Mailing address: 7920 Elmbrook Rd., Dallas, TX 75247.
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CENTER FOR VETERINARY MEDICINE.\16\
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    \16\ Mailing address: 7500 Standish Pl., MPN-2, Rockville, MD 
20855.
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Office of the Center Director.
Office of Management.
Management Services Staff.
Information Resources Management Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for Food Animals.
Division of Biometrics and Production Drugs.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Human Food Safety.
Division of Manufacturing Technologies.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Epidemiology.
Office of Research.
Administrative Staff.
Division of Residue Chemistry.
Division of Animal Research.
Division of Animal and Food Microbiology.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.\17\
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    \17\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
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Office of the Center Director.
Equal Employment Opportunity Staff.
Office of Systems and Management.
Division of Ethics and Management Operations.
Division of Information Technology.
Division of Planning, Analysis and Finance.
Office of Compliance.
Promotion and Advertising Policy Staff.
Division of Bioresearch Monitoring.
Division of Program Operations.
Division of Enforcement A.
Division of Enforcement B.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Division of Cardiovascular Devices.
Division of Reproductive, Abdominal, and Radiological Devices.
Division of General, Restorative, and Neurological Devices.
Division of Ophthalmic, and Ear, Nose and Throat Devices.
Division of Anesthesiology, General Hospital, Infection Control, and 
Dental Devices.
Office of Science and Technology.
Division of Mechanics and Materials Science.
Division of Life Sciences.
Division of Physical Sciences.
Division of Electronics and Computer Sciences.
Division of Management, Information and Support Services.
Office of Health and Industry Programs.
Program Operations Staff.
Regulations Staff.
Staff College.
Division of Device User Programs and Systems Analysis.
Division of Small Manufacturers Assistance.
Division of Mammography Quality and Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics.
Issues Management Staff.
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Office of In Vitro Diagnostic Device Evaluation and Safety.
Division of Chemistry and Toxicology Devices.
Division of Immunology and Hematology Devices.
Division of Microbiology.
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH.\18\
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    \18\ Mailing address: 3900 NCTR Dr., Jefferson, AR 72079.
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Office of the Center Director.
Environmental Health and Program Assurance Staff.
Office of Research.
Technology Advancement Staff.
Division of Biochemical Toxicology.
Division of Genetic and Reproductive Toxicology.
Division of Biometry and Risk Assessment.
Division of Microbiology.
Division of Chemistry.
Division of Neurotoxicology.
Division of Veterinary Services.
Division of Molecular Epidemiology.
Office of Management.
Office of Management Services.
Division of Facilities, Engineering and Maintenance.
Division of Administrative Services.
Division of Contracts and Acquisitions.
Office of Planning, Finance and Information Technology.
Division of Planning.
Division of Financial Management.
Division of Information Technology.


Sec.  5.1105  Chief Counsel, Food and Drug Administration.

    The Office of the Chief Counsel's mailing address is 5600 Fishers 
Lane, rm. 6-05, Rockville, MD 20857.\1\
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    \1\ The Office of the Chief Counsel (also known as the Food and 
Drug Division, Office of the General Counsel, Department of Health 
and Human Services), while administratively within the Office of the 
Commissioner, is part of the Office of the General Counsel of the 
Department of Health and Human Services.
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Sec.  5.1110  FDA public information offices.

    (a) Division of Dockets Management (HFA-305). The Division of 
Dockets Management public room is located in rm. 1061, 5630 Fishers 
Lane, Rockville, MD 20852. Telephone: 301-827-6860.
    (b) Division of Freedom of Information (HFI-35). The Freedom of 
Information public room is located in rm. 12A-30, Parklawn Bldg., 5600 
Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6567.
    (c) Press Relations Staff (HFI-40). Press offices are located in 
rm. 15-A07, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. 
Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy., College Park, 
MD 20740. Telephone: 301-436-2335.


Sec.  5.1115  Field structure.

    NORTHEAST REGION
Regional Field Office: 158-15 Liberty Ave., Jamaica, NY 11433.
Northeast Regional Laboratory: 158-15 Liberty Ave., Jamaica, NY 11433.
New York District Office: 158-15 Liberty Ave., Jamaica, NY 11433.
New England District Office: One Montvale Ave., Stoneham, MA 02180.
Winchester Engineering and Analytical Center: 109 Holton St., 
Winchester, MA 01890.
    CENTRAL REGION
Regional Field Office: U.S. Customhouse, Second and Chestnut Sts., rm. 
900, Philadelphia, PA 19106.

[[Page 17290]]

Philadelphia District Office: U.S. Customhouse, Second and Chestnut 
Sts., rm. 900, Philadelphia, PA 19106.
Baltimore District Office: 6000 Metro Dr., suite 101, Baltimore, MD 
21215.
Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-3097.
Forensic Chemistry Center: 6751 Steger Dr., Cincinnati, OH 45237-3097.
New Jersey District Office: Waterview Corporate Center, 10 Waterview 
Blvd., 3d floor, Parsippany, NJ 07054.
Chicago District Office: 550 West Jackson Blvd., suite 1500, South 
Chicago, IL 60661.
Detroit District Office: 300 River Pl., suite 5900, Detroit, MI 48207.
Minneapolis District Office: 212 Third Ave. South, Minneapolis, MN 
55401.
    SOUTHEAST REGION
Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309.
Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309.
Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309.
New Orleans District Office: 6600 Plaza Dr., suite 400, New Orleans, LA 
70122.
Florida District Office: 555 Winderley, suite 200, Maitland, FL 32751.
San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 
00901-3223.
    SOUTHWEST REGION
Regional Field Office: 4040 North Central Expressway, suite 900, 
Dallas, TX 75204.
Dallas District Office: 4040 North Central Expressway, suite 300, 
Dallas, TX 75204.
Denver District Office: Bldg. 20, Denver Federal Center, Sixth and 
Kipling Sts., P.O. Box 25087, Denver, CO 80225-0087.
Kansas City District Office: 11630 West 80th St., Lenexa, KS 66214-
3338.
St. Louis Branch: 12 Sunnen Dr., suite 122, St. Louis, MO 63143-3800.
Arkansas Regional Laboratory: 3900 NCTR Rd., Bldg. 26, Jefferson, AR 
72079-9502.
Southwest Import District Office: 4040 North Central Expressway, suite 
300, Dallas, TX 75204.
    PACIFIC REGION
Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 94512-
5217.
San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 
94502-7070.
Los Angeles District Office: 19701 Fairchild, Irvine, CA 92612.
Seattle District Office: 22201 23rd Dr. SE., Bothell, WA 98021-4421.
Pacific Regional Laboratory, SW: 19701 Fairchild, Irvine, CA 92612.
Pacific Regional Laboratory, NW: 22201 23rd Dr. SE., Bothell, WA 98021-
4421.

PART 7--ENFORCEMENT POLICY

0
2. The authority citation for 21 CFR part 7 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 
264.

0
3. Section 7.45 is amended by revising the introductory text of 
paragraph (a) to read as follows:


Sec.  7.45  Food and Drug Administration-requested recall.

    (a) The Commissioner of Food and Drugs or designee may request a 
firm to initiate a recall when the following determinations have been 
made: * * *
* * * * *

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
4. The authority citation for 21 CFR part 10 continues to read as 
follows:

    Authority: 5 U.S.C. 551-558, 701-706, 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

0
5. Section 10.1 is amended by revising paragraph (a) to read as 
follows:


Sec.  10.1  Scope.

    (a) Part 10 governs practices and procedures for petitions, 
hearings, and other administrative proceedings and activities conducted 
by the Food and Drug Administration under the Federal Food, Drug, and 
Cosmetic Act, the Public Health Service Act, and other laws which the 
Commissioner of Food and Drugs administers.
* * * * *

0
6. Section 10.3 is amended in paragraph (a) by revising the definition 
for ``The laws administered by the Commissioner'' to read as follows:


Sec.  10.3  Definitions.

    (a) * * *
    The laws administered by the Commissioner or the laws administered 
by the Food and Drug Administration means all the laws that the 
Commissioner is authorized to administer.
* * * * *

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
7. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
8. Section 16.26 is amended by revising paragraph (a) to read as 
follows:


Sec.  16.26  Denial of hearing and summary decision.

    (a) A request for a hearing may be denied, in whole or in part, if 
the Commissioner or the FDA official to whom authority is delegated to 
make the final decision on the matter determines that no genuine and 
substantial issue of fact has been raised by the material submitted. If 
the Commissioner or his or her delegate determines that a hearing is 
not justified, written notice of the determination will be given to the 
parties explaining the reason for denial.
* * * * *

0
9. Section 16.40 is revised to read as follows:


Sec.  16.40  Commissioner.

    Whenever the Commissioner has delegated authority on a matter for 
which a regulatory hearing is available under this part, the functions 
of the Commissioner under this part may be performed by any of the 
officials to whom the authority has been delegated, e.g., a center 
director.

PART 21--PROTECTION OF PRIVACY

0
10. The authority citation for 21 CFR part 21 continues to read as 
follows:

    Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.

0
11. Section 21.43 is amended by revising paragraph (a)(2) to read as 
follows:


Sec.  21.43  Access to requested records.

    (a) * * *
    (2) Permitting the requesting individual to review the records in 
person between 9 a.m. and 4 p.m. at the office of the FDA Privacy Act 
Coordinator, at the Freedom of Information Staff public room at the 
address shown in Sec.  20.30 of this chapter, or at any Food and Drug 
Administration field office, listed in part 5, subpart M of this 
chapter, or at another location or time upon which the Food and Drug 
Administration and the individual agree. Arrangement for such review 
can be made by consultation between the FDA Privacy Act Coordinator and 
the individual. An individual seeking to review records in person shall 
generally be permitted access to the file copy, except that where the 
records include nondisclosable information, a copy shall be made of 
that portion of the records, with the nondisclosable information 
blocked out. Where the individual is not given a copy of the record to 
retain, no charge shall be made for the cost of copying a record to 
make it available to

[[Page 17291]]

an individual who reviews a record in person under this paragraph.
* * * * *

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
12. The authority citation for 21 CFR part 25 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 
Comp., 356-360.

0
13. Section 25.5 is amended by revising paragraph (b)(5) to read as 
follows:


Sec.  25.5  Terminology.

* * * * *
    (b) * * *
    (5) Responsible agency official means the agency decisionmaker 
designated in the delegated authority for the underlying actions.
* * * * *

0
14. Section 25.40 is amended by revising paragraph (e) to read as 
follows:


Sec.  25.40  Environmental assessments.

* * * * *
    (e) The agency evaluates the information contained in an EA and any 
public input to determine whether it is accurate and objective, whether 
the proposed action may significantly affect the quality of the human 
environment, and whether an EIS or a FONSI will be prepared. The 
responsible agency official examines the environmental risks of the 
proposed action and the alternative courses of action, selects a course 
of action, and ensures that any necessary mitigating measures are 
implemented as a condition for approving the selected course of action.

0
15. Section 25.45 is amended by revising paragraph (a) to read as 
follows:


Sec.  25.45  Responsible agency official.

    (a) The responsible agency official prepares the environmental 
documents or ensures that they are prepared.
* * * * *

PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES

0
16. The authority citation for 21 CFR part 106 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 350a, 371.

0
17. Section 106.120 is amended by revising paragraph (b) to read as 
follows:


Sec.  106.120  New formulations and reformulations.

* * * * *
    (b) The manufacturer shall promptly notify the Food and Drug 
Administration when the manufacturer has knowledge (as defined in 
section 412(c)(2) of the act) that reasonably supports the conclusion 
that an infant formula that has been processed by the manufacturer and 
that has left an establishment subject to the control of the 
manufacturer may not provide the nutrients required by section 412(g) 
of the act and by regulations promulgated under section 412(a)(2) of 
the act, or when there is an infant formula that is otherwise 
adulterated or misbranded and that may present risk to human health. 
This notification shall be made, by telephone, to the Director of the 
appropriate Food and Drug Administration district office specified in 
part 5, subpart M of this chapter. After normal business hours (8 a.m. 
to 4:30 p.m.) the FDA emergency number, 301-443-1240, shall be used. 
The manufacturer shall send a followup written confirmation to the 
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to 
the appropriate Food and Drug Administration district office specified 
in part 5, subpart M of this chapter.

PART 107--INFANT FORMULA

0
18. The authority citation for 21 CFR part 107 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 343, 350a, 371.

0
19. Section 107.50 is amended by revising paragraph (e)(2) to read as 
follows:


Sec.  107.50  Terms and conditions.

* * * * *
    (e) * * *
    (2) The manufacturer shall promptly notify FDA when the 
manufacturer has knowledge (as defined in section 412(c)(2) of the act) 
that reasonably supports the conclusion that an exempt infant formula 
that has been processed by the manufacturer and that has left an 
establishment subject to the control of the manufacturer may not 
provide the nutrients required by paragraph (b) or (c) of this section, 
or when there is an exempt infant formula that may be otherwise 
adulterated or misbranded and if so adulterated or misbranded presents 
a risk of human health. This notification shall be made, by telephone, 
to the Director of the appropriate FDA district office specified in 
part 5, subpart M of this chapter. After normal business hours (8 a.m. 
to 4:30 p.m.), the FDA emergency number, 301-443-1240, shall be used. 
The manufacturer shall send a followup written confirmation to the 
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to 
the appropriate FDA district office specified in part 5, subpart M of 
this chapter.

0
20. Section 107.230 is amended by revising paragraph (e) to read as 
follows:


Sec.  107.230  Elements of an infant formula recall.

* * * * *
    (e) The recalling firm shall furnish promptly to the appropriate 
Food and Drug Administration district office listed in part 5, subpart 
M of this chapter, as they are available, copies of the health hazard 
evaluation, the recall strategy, and all recall communications 
(including, for a recall under Sec.  107.200, the notice to be 
displayed at retail establishments) directed to consignees, 
distributors, retailers, and members of the public.

0
21. Section 107.240 is amended by revising paragraphs (b) and (c)(1) to 
read as follows:


Sec.  107.240  Notification requirements.

* * * * *
    (b) Method of notification. The notification made pursuant to Sec.  
107.240(a) shall be made, by telephone, to the Director of the 
appropriate Food and Drug Administration district office listed in part 
5, subpart M of this chapter. After normal business hours (8 a.m. to 
4:30 p.m.), FDA's emergency number, 301-443-1240, shall be used. The 
manufacturer shall send written confirmation of the notification to the 
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to 
the appropriate Food and Drug Administration district office listed in 
part 5, subpart M of this chapter.
    (c) * * * (1) Telephone report. When a determination is made that 
an infant formula is to be recalled, the recalling firm shall telephone 
within 24 hours the appropriate Food and Drug Administration district 
office listed in part 5, subpart M of this chapter and shall provide 
relevant information about the infant formula that is to be recalled.
* * * * *

0
22. Section 107.250 is amended by revising the introductory paragraph 
to read as follows:


Sec.  107.250  Termination of an infant formula recall.

    The recalling firm may submit a recommendation for termination of 
the

[[Page 17292]]

recall to the appropriate Food and Drug Administration district office 
listed in part 5, subpart M of this chapter for transmittal to the 
Center for Food Safety and Applied Nutrition (HFS-605), for action. Any 
such recommendation shall contain information supporting a conclusion 
that the recall strategy has been effective. The agency will respond 
within 15 days of receipt by the Center for Food Safety and Applied 
Nutrition (HFS-605), of the request for termination. The recalling firm 
shall continue to implement the recall strategy until it receives final 
written notification from the agency that the recall has been 
terminated. The agency will send such a notification unless it has 
information, from FDA's own audits or from other sources, demonstrating 
that the recall has not been effective. The agency may conclude that a 
recall has not been effective if:
* * * * *

PART 203--PRESCRIPTION DRUG MARKETING

0
23. The authority citation for 21 CFR part 203 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 
381.

0
24. Section 203.11 is amended by revising paragraph (a) to read as 
follows:


Sec.  203.11  Applications for reimportation to provide emergency 
medical care.

    (a) Applications for reimportation for emergency medical care shall 
be submitted to the director of the FDA District Office in the district 
where reimportation is sought (addresses found in part 5, subpart M of 
this chapter).
* * * * *

PART 500--GENERAL

0
25. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371.

0
26. Section 500.80 is amended by revising paragraph (a) to read as 
follows:


Sec.  500.80  Scope of this subpart.

    (a) The Federal Food, Drug, and Cosmetic Act requires that 
sponsored compounds intended for use in food-producing animals be shown 
to be safe and that food produced from animals exposed to these 
compounds be shown to be safe for consumption by people. The statute 
prohibits the use in food-producing animals of any compound found to 
induce cancer when ingested by people or animals unless it can be 
determined by methods of examination prescribed or approved by the 
Secretary (a function delegated to the Commissioner of Food and Drugs) 
that no residue of that compound will be found in the food produced 
from those animals under conditions of use reasonably certain to be 
followed in practice. This subpart identifies the steps a sponsor of a 
compound shall follow to secure the approval of the compound. FDA 
guidance documents contain the procedures and protocols FDA recommends 
for the implementation of this subpart. These guidance documents are 
available from the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests for these guidance documents should be identified with Docket 
No. 1983D-0288.
* * * * *

PART 800--GENERAL

0
27. The authority citation for 21 CFR part 800 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.

0
28. Section 800.55 is amended by revising paragraph (g)(4) to read as 
follows:


Sec.  800.55  Administrative detention.

* * * * *
    (g) * * *
    (4) The presiding officer of a regulatory hearing on an appeal of a 
detention order, who also shall decide the appeal, shall be a regional 
food and drug director (i.e., a director of an FDA regional office 
listed in part 5, subpart M of this chapter) who is permitted by Sec.  
16.42(a) of this chapter to preside over the hearing.
* * * * *

PART 1002--RECORDS AND REPORTS

0
29. The authority citation for 21 CFR part 1002 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374.

0
30. Section 1002.3 is revised to read as follows:


Sec.  1002.3  Notification to user of performance and technical data.

    The Director and Deputy Director of the Center for Devices and 
Radiological Health, as authorized under delegated authority, may 
require a manufacturer of a radiation emitting electronic product to 
provide to the ultimate purchaser, at the time of original purchase, 
such performance data and other technical data related to safety of the 
product as the Director or Deputy Director finds necessary.

    Dated: March 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.

[[Page 17293]]

Note: This appendix will not appear in the Code of Federal Regulations.

  Appendix A--Part 5; Corresponding Former Subparts, Section Numbers, and Subjects and New Alternate Internet-
                                   Based System FDA Staff Manual Guide Numbers
----------------------------------------------------------------------------------------------------------------
                                                         Alternate Internet-Based System  FDA Staff Manual Guide
      Former CFR Subpart, Section No., and Subject           (SMG) Numbers (Subject remains, unless otherwise
                                                                                 stated)
----------------------------------------------------------------------------------------------------------------
Subpart Key:                                             SMG Index:
Subpart A, Sec.   5.10 to Sec.   5.19--Delegations of    SMG 1410.10--Delegations of Authority to the
 Authority to the Commissioner                            Commissioner of Food and Drugs
Subpart B, Sec.   5.20 to Sec.   5.99--General           SMG 1410.20--General Redelegations of Authority
 Redelegations of Authority                              SMG 1410.100--Human Drugs
Subpart C, Sec.   5.100 to Sec.   5.199--Human Drugs;    SMG 1410.200--Biologics
 Redelegations of Authority                              SMG 1410.300--Foods and Cosmetics
Subpart D, Sec.   5.200 to Sec.   5.299--Biologics;      SMG 1410.400--Medical Devices and Radiological Health
 Redelegations of Authority                              SMG 1410.500--Animal Drugs
Subpart E, Sec.   5.300 to Sec.   5.399--Foods and       SMG 1410.600--Radiation Control
 Cosmetics; Redelegations of Authority                   SMG 1410.700--Product Designation
Subpart F, Sec.   5.400 to Sec.   5.499--Medical         SMG 1410.800--Imports and Exports
 Devices and Radiological Health; Redelegations of       SMG 1410.900--Orphan Products
 Authority                                               SMG 1410.1000--Mammography Facilities
Subpart G, Sec.   5.500 to Sec.   5.599--Animal Drugs;
 Redelegations of Authority
Subpart H, Sec.   5.600 to Sec.   5.699--Radiation
 Control; Redelegations of Authority
Subpart I, Sec.   5.700 to Sec.   5.799--Product
 Designation; Redelegations of Authority
Subpart J, Sec.   5.800 to Sec.   5.899--Imports and
 Exports; Redelegations of Authority
Subpart K, Sec.   5.900 to Sec.   5.999--Orphan
 Products; Redelegations of Authority
Subpart L, Sec.   5.1000--Mammography Facilities;
 Redelegations of Authority
Subpart M, Sec.   5.1100--Organization
----------------------------------------------------------------------------------------------------------------
Subpart A, Sec.   5.10--Delegations From the Secretary   SMG 1410.10--Delegations of Authority to The
 of Health and Human Services to the Commissioner of      Commissioner of Food and Drugs
 Food and Drugs.                                         (Note: Paragraph 2 of this SMG contains the Reservation
Subpart A, Sec.   5.11--Reservation of authority.         of Authority.)
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.20--General redelegations of         SMG 1410.21
 authority from the Commissioner to other officers of
 the Food and Drug Administration.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.21--Emergency functions.             SMG 1410.22
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.22--Certification of true copies     SMG 1410.23
 and use of Department seal.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.23--Disclosure of official records   SMG 1410.24
 and authorization of testimony.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.24--Authority relating to            SMG 1410.25
 technology transfer.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.25--Research, investigation, and     SMG 1410.26--Research, Investigation, and Testing
 testing programs and health information and promotion    Programs and Health Promotion Programs
 programs.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.26--Service fellowships.             SMG 1410.27
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.27--Patent term extensions for       SMG 1410.18
 human drug products, medical devices, and food and
 color additives; and authority to perform due
 diligence determinations and informal hearings.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.28--Hearings.                        SMG 1410.29
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.29--Petitions under part 10.         SMG 1410.30--Petitions Under Title 21, Code of Federal
                                                          Regulations (21 CFR), Part 10
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.30--Authority to select temporary    SMG 1410.31
 voting members for advisory committees and authority
 to sign conflict of interest waivers.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.31--Enforcement activities.          SMG 1410.32
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.32--Certification following          SMG 1410.33
 inspections.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.33--Issuance of reports of minor     SMG 1410.34
 violations.
----------------------------------------------------------------------------------------------------------------

[[Page 17294]]

 
Subpart B, Sec.   5.34--Issuance of notices relating to  SMG 1410.35
 proposals and orders for debarment and denial of an
 application to terminate debarment.
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   5.35--Officials authorized to make     SMG 1410.36
 certification under 5 U.S.C. 605(b) for any proposed
 and final rules.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.100--Issuance of notices             SMG 1410.101
 implementing the provisions of the Drug Amendments of
 1962.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.101--Termination of exemptions for   SMG 1410.102
 new drugs for investigational use in human beings.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.102--Authority to approve and to     SMG 1410.103
 withdraw approval of a charge for investigational new
 drugs.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.103--Approval of new drug            SMG 1410.104
 applications and their supplements.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.104--Responses to Drug Enforcement   SMG 1410.105
 Administration temporary scheduling notices.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.105--Issuance of notices relating    SMG 1410.106
 to proposals to refuse approval or to withdraw
 approval of new drug applications and their
 supplements.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.106--Submission of and effective     SMG 1410.107
 approval dates for abbreviated new drug applications
 and certain new drug applications.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.107--Extensions or stays of          SMG 1410.108
 effective dates for compliance with certain labeling
 requirements for human prescription drugs.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.108--Authority relating to waivers   SMG 1410.109
 or reductions of prescription drug user fees.
----------------------------------------------------------------------------------------------------------------
Subpart C, Sec.   5.109--Issuance of written notices     SMG 1410.110
 concerning patent information, current good
 manufacturing practices and false or misleading
 labeling of new drugs.
----------------------------------------------------------------------------------------------------------------
Subpart D, Sec.   5.200--Functions pertaining to safer   SMG 1410.201
 vaccines.
----------------------------------------------------------------------------------------------------------------
Subpart D, Sec.   5.201--Redelegation of the Center for  SMG 1410.202
 Biologics Evaluation and Research Director's program
 authorities.
----------------------------------------------------------------------------------------------------------------
Subpart D, Sec.   5.202--Issuance of notices of          SMG 1410.203
 opportunity for a hearing on proposals for denial of
 approval of applications for licenses, suspension of
 licenses, or revocation of licenses and certain
 notices of revocation of licenses.
----------------------------------------------------------------------------------------------------------------
Subpart D, Sec.   5.203--Issuance and revocation of      SMG 1410.204
 licenses for the propagation or manufacture and
 preparation of biological products.
----------------------------------------------------------------------------------------------------------------
Subpart D, Sec.   5.204--Notification of release for     SMG 1410.205
 distribution of biological products.
----------------------------------------------------------------------------------------------------------------
Subpart E, Sec.   5.300--Food standards, food            SMG 1410.301--Food Standards, Food Additives, Generally
 additives, generally recognized as safe (GRAS)           Recognized As Safe (GRAS) Substances, Color Additives,
 substances, color additives, nutrient content claims,    Nutrient Claims, and Health Claims
 and health claims.
----------------------------------------------------------------------------------------------------------------
Subpart E, Sec.   5.301--Issuance of initial emergency   SMG 1410.302
 permit orders and notices of confirmation of effective
 date of final regulations on food for human and animal
 consumption.
----------------------------------------------------------------------------------------------------------------
Subpart E, Sec.   5.302--Detention of meat, poultry,     SMG 1410.303
 eggs, and related products.
----------------------------------------------------------------------------------------------------------------
Subpart E, Sec.   5.303--Establishing standards and      SMG 1410.304
 approving accrediting bodies under the National
 Laboratory Accreditation Program.
----------------------------------------------------------------------------------------------------------------

[[Page 17295]]

 
Subpart E, Sec.   5.304--Approval of schools providing   SMG 1410.305
 food-processing instruction.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.400--Issuance of Federal Register    SMG 1410.401
 documents to recognize or to withdraw recognition of a
 standard to meet premarket submission requirements.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.401--Issuance of Federal Register    SMG 1410.402--Issuance of Federal Register Documents
 documents pertaining to exemptions from premarket        Pertaining to Premarket Submission Requirements and
 notification.                                            Exemption from Premarket Notification
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.402--Detention of adulterated or     SMG 1410.403
 misbranded medical devices
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.403--Authorization to use            SMG 1410.404
 alternative evidence for determination of the
 effectiveness of medical devices.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.404--Notification to petitioners of  SMG 1410.405
 determinations made on petitions for reclassification
 of medical devices.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.405--Determination of                SMG 1410.406
 classification of devices.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.406--Notification to sponsors of     SMG 1410.407
 deficiencies in petitions for reclassification of
 medical devices.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.407--Approval, disapproval, or       SMG 1410.408
 withdrawal of approval of product development
 protocols and applications for premarket approval for
 medical devices.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.408--Determinations concerning the   SMG 1410.409
 type of valid scientific evidence submitted in a
 premarket approval application.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.409--Determinations that medical     SMG 1410.410
 devices present unreasonable risk of substantial harm.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.410--Orders to repair or replace,    SMG 1410.411
 or make refunds for, medical devices.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.411--Medical device recall           SMG 1410.412
 authority.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.412--Temporary suspension of a       SMG 1410.413
 medical device application.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.413--Approval, disapproval, or       SMG 1410.414
 withdrawal of approval of applications and entering
 into agreements for investigational device exemptions.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.414--Postmarket surveillance.        SMG 1410.415
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.415--Authority relating to medical   SMG 1410.416
 device reporting procedures.
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.416--Medical device tracking.        SMG 1410.417
----------------------------------------------------------------------------------------------------------------
Subpart F, Sec.   5.417--Authority pertaining to         SMG 1410.418
 accreditation functions for medical devices.
----------------------------------------------------------------------------------------------------------------
Subpart G, Sec.   5.500--Issuance of Federal Register    SMG 1410.501
 documents pertaining to the determination of safe
 levels, notice of need for development of an
 analytical method, notice of availability of a
 developed analytical method, and prohibition of
 certain extralabel drug use.
----------------------------------------------------------------------------------------------------------------
Subpart G, Sec.   5.501--Approval of new animal drug     SMG 1410.502
 applications, medicated feed mill license applications
 and their supplements.
----------------------------------------------------------------------------------------------------------------
Subpart G, Sec.   5.502--Issuance of notices,            SMG 1410.503
 proposals, and orders relating to new animal drugs and
 medicated feed mill license applications.
----------------------------------------------------------------------------------------------------------------

[[Page 17296]]

 
Subpart G, Sec.   5.503--Submission of and effective     SMG 1410.504
 approval dates for abbreviated new animal drug
 applications and certain new animal drug applications.
----------------------------------------------------------------------------------------------------------------
Subpart G, Sec.   5.504--Issuance of written notices     SMG 1410.505
 concerning patent information, current good
 manufacturing practices and false or misleading
 labeling of new animal drugs and feeds bearing or
 containing new animal drugs.
----------------------------------------------------------------------------------------------------------------
Subpart G, Sec.   5.505--Termination of exemptions for   SMG 1410.506
 new drugs for investigational use in animals.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.600--Variances from performance      SMG 1410.601
 standards for electronic products.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.601--Exemption of electronic         SMG 1410.602
 products from performance standards and prohibited
 acts.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.602--Testing programs and methods    SMG 1410.603
 of certification and identification for electronic
 products.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.603--Notification of defects in,     SMG 1410.604
 and repair or replacement of, electronic products.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.604--Manufacturers requirement to    SMG 1410.605
 provide data to ultimate purchasers of electronic
 products.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.605--Dealer and distributor          SMG 1410.606
 direction to provide data to manufacturers of
 electronic products.
----------------------------------------------------------------------------------------------------------------
Subpart H, Sec.   5.606--Acceptance of assistance from   SMG 1410.607
 State and Local authorities for enforcement of
 radiation control legislation and regulations.
----------------------------------------------------------------------------------------------------------------
Subpart I, Sec.   5.700--Authority relating to           SMG 1410.701
 determination of product primary jurisdiction.
----------------------------------------------------------------------------------------------------------------
Subpart I, Sec.   5.701--Premarket approval of a         SMG 1410.702
 product that is or contains a biologic, a device, or a
 drug.
----------------------------------------------------------------------------------------------------------------
Subpart J, Sec.   5.800--Imports and exports.            SMG 1410.801
----------------------------------------------------------------------------------------------------------------
Subpart J, Sec.   5.801--Export of unapproved drugs.     SMG 1410.802
----------------------------------------------------------------------------------------------------------------
Subpart J, Sec.   5.802--Manufacturer's resident import  SMG 1410.803
 agents.
----------------------------------------------------------------------------------------------------------------
Subpart K, Sec.   5.900--Orphan products.                SMG 1410.901
----------------------------------------------------------------------------------------------------------------
Subpart L, Sec.   5.1000--Authority to ensure that       SMG 1410.1000
 mammography facilities meet quality standards.
----------------------------------------------------------------------------------------------------------------
Subpart M--Organization                                  (Note: Subpart M will remain in the CFR and it is
                                                          updated in this final rule.)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 04-7398 Filed 4-1-04; 8:45 am]
BILLING CODE 4160-01-S