21 CFR 10.206 - Procedures for electronic media coverage of agency public administrative proceedings.

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§ 10.206 Procedures for electronic media coverage of agency public administrative proceedings.
(a) To facilitate the agency's response to media needs, a person intending to videotape an FDA public administrative proceeding should, whenever possible, provide advance notice to the Press Relations Staff (HFI-20), Office of Public Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, in writing or by telephone (telephone 301-443-4177), at least 48 hours in advance of the proceeding. The Press Relations Staff will inform the presiding officer that the proceeding will be attended by representatives of the electronic media, and ascertain whether any special provisions in addition to those set forth in this subpart are required by the presiding officer. If so, the Press Relations Staff will function as a liaison between the presiding officer and the person intending to record the proceeding in facilitating any procedures in addition to those outlined in this subpart. The presiding officer will not deny access for failure to provide a 48-hour advance notice. Any advance notice may describe the intended length of recording if known, the amount and type of equipment to be used, and any special needs such as interviews.
(b) Cameras should be completely set up before a proceeding is scheduled to begin or during a break in the proceeding and should remain standing in the area designated for electronic media equipment. Cameras may be taken down only during breaks or after the hearing is over. Roving cameras will not be permitted during the proceeding. Any artificial lighting should be unobtrusive. Microphones, like cameras, should be in place before the start of a proceeding and may be taken down as indicated in this paragraph.
(c) When space in the hearing room is limited, the presiding officer may restrict the number of cameras or the equipment present. Should such a restriction become necessary, the pool arrangements are the responsibility of the participating media. The agency encourages the network pool to make copies of the tape, film, or other product available at cost to nonpool participants. However, if this is not possible, the agency may need to use the time of receipt of any advance notice to determine the representation for each category, e.g., one network reporter, one independent reporter, etc.
(d) Off the record portions of a proceeding may not be videotaped.
(e) Before or during the proceeding, the presiding officer may establish other conditions specific to the proceeding for which the request is being made. These conditions may be more or less restrictive than those stated in this guideline, except that the presiding officer shall observe the agency's presumption of openness of its public proceedings to the electronic media. Only a substantial and clear threat to the agency's interests in order, fairness, and timeliness authorizes the presiding officer to impose additional restrictions. This threat must outweigh the public interest in electronic media coverage of agency proceedings. Additional restrictions shall be narrowly drawn to the particular circumstances. The following factors are listed to assist presiding officers in determining whether the agency's interest is sufficiently compelling to call for the unusual step of imposing additional restrictions. Generally this step is justified when one of the following factors is met:
(1) Electronic recording would result in a substantial likelihood of disruption that clearly cannot be contained by the procedures established in paragraphs (a) through (d) of this section.
(2) Electronic recording would result in a substantial likelihood of prejudicial impact on the fairness of the proceeding or the substantive discussion in a proceeding.
(3) There is a substantial likelihood that a witness' ability to testify may be impaired due to unique personal circumstances such as the age or psychological state of the witness or the particularly personal or private nature of the witness' testimony, if the witness' testimony were electronically recorded.
(f) Before the proceeding, the Press Relations Staff will, upon request, provide written copies of any additional conditions imposed by the presiding officer (as described in paragraph (e) of this section) to requesting members of the media. Any appeals should be made in accordance with paragraph (h) of this section.
(g) The presiding officer retains authority to restrict or discontinue videotaping or other recording of a proceeding, or parts of a proceeding, should such a decision become necessary. The presiding officer's responsibility to conduct the hearing includes the right and duty to remove a source of substantial disruption. In exercising his or her authority, the presiding officer shall observe the presumption that agency public proceedings are open to the electronic media. The presiding officer shall exercise his or her discretion to restrict or discontinue electronic coverage of a public proceeding, or portions of a public proceeding, only if he or she determines that the agency's interest in the fair and orderly administrative process is substantially threatened. A clear and substantial threat to the integrity of agency proceedings must clearly outweigh the public interest in electronic media coverage of the proceedings before additional restrictions are imposed on the electronic media during the course of the proceedings. The factors noted in paragraph (e) of this section indicate the kind of substantial threat to the agency interests that may require imposing additional restrictions during the course of the proceedings. If additional requirements are established during the hearing, the presiding officer shall notify immediately the Deputy Commissioner of Food and Drugs of that fact by telephone and submit a written explanation of the circumstances that necessitated such an action within 24 hours or sooner if requested by the Deputy Commissioner. In the absence or unavailability of the Deputy Commissioner, the presiding officer shall notify the Associate Commissioner for Regulatory Affairs.
(h) A decision by a presiding officer, made either before the proceeding or during the course of a proceeding, to establish requirements in addition to the minimum standards set forth in this guideline may be appealed by any adversely affected person who intends to record the proceeding electronically. Appeals may be made in writing or by phone to the Deputy Commissioner or, in his or her absence, to the Associate Commissioner for Regulatory Affairs. The filing of an appeal, whether before or during a proceeding, does not require the presiding officer to interrupt the proceeding. However, the Deputy Commissioner or, in his or her absence, the Associate Commissioner for Regulatory Affairs will resolve an appeal as expeditiously as possible so as to preserve, to the extent possible, the reporters' opportunity to record the proceedings.
[49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-12-19; vol. 78 # 244 - Thursday, December 19, 2013
    1. 78 FR 76748 - Citizen Petition Submission; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This final rule is effective December 19, 2013.
      21 CFR Part 10

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 141 - Prohibition of importation without permit

§ 142 - Milk or cream when unfit for importation

§ 143 - Inspection; certified statement in lieu thereof; waiver of requirements of

§ 144 - Unlawful receiving of imported milk or cream

§ 145 - Penalties

§ 146 - Authorization of appropriations

§ 147 - Repeal of inconsistent laws

§ 148 - Powers of State with respect to milk or cream lawfully imported

§ 149 - Definitions

§ 321 - Definitions; generally

§ 321a - “Butter” defined

§ 321b - “Package” defined

§ 321c - Nonfat dry milk; “milk” defined

§ 321d - Market names for catfish and ginseng

§ 331 - Prohibited acts

§ 332 - Injunction proceedings

§ 333 - Penalties

§ 333a - Repealed.

§ 334 - Seizure

§ 335 - Hearing before report of criminal violation

§ 335a - Debarment, temporary denial of approval, and suspension

§ 335b - Civil penalties

§ 335c - Authority to withdraw approval of abbreviated drug applications

§ 336 - Report of minor violations

§ 337 - Proceedings in name of United States; provision as to subpoenas

§ 341 - Definitions and standards for food

§ 342 - Adulterated food

§ 343 - Misbranded food

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 343a - Repealed.

§ 344 - Emergency permit control

§ 345 - Regulations making exemptions

§ 346 - Tolerances for poisonous or deleterious substances in food; regulations

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 346b - Authorization of appropriations

§ 347 - Intrastate sales of colored oleomargarine

§ 347a - Congressional declaration of policy regarding oleomargarine sales

§ 347b - Contravention of State laws

§ 348 - Food additives

§ 349 - Bottled drinking water standards; publication in Federal Register

§ 350 - Vitamins and minerals

§ 350a - Infant formulas

§ 350b - New dietary ingredients

§ 350c - Maintenance and inspection of records

§ 350d - Registration of food facilities

§ 350e - Sanitary transportation practices

§ 350f - Reportable food registry

§ 350g - Hazard analysis and risk-based preventive controls

§ 350h - Standards for produce safety

§ 350i - Protection against intentional adulteration

§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

§ 350k - Laboratory accreditation for analyses of foods

21 U.S. Code § -

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 353a - Pharmacy compounding

§ 353b - Outsourcing facilities

§ 354 - Veterinary feed directive drugs

§ 355 - New drugs

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 355a - Pediatric studies of drugs

§ 355b - Adverse-event reporting

§ 355c - Research into pediatric uses for drugs and biological products

§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

§ 355e - Pharmaceutical security

§ 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 356a - Manufacturing changes

§ 356b - Reports of postmarketing studies

§ 356c - Discontinuance or interruption in the production of life-saving drugs

§ 357 - Repealed.

§ 358 - Authority to designate official names

§ 359 - Nonapplicability of subchapter to cosmetics

§ 360 - Registration of producers of drugs or devices

§ 360a - Clinical trial guidance for antibiotic drugs

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 360f - Banned devices

§ 360g - Judicial review

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360k - State and local requirements respecting devices

21 U.S. Code § -

§ 360m - Accredited persons

§ 360n - Priority review to encourage treatments for tropical diseases

§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions

§ 360bb - Designation of drugs for rare diseases or conditions

§ 360cc - Protection for drugs for rare diseases or conditions

§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions

§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions

§ 360hh - Definitions

§ 360ii - Program of control

§ 360jj - Studies by Secretary

§ 360kk - Performance standards for electronic products

21 U.S. Code § -

§ 360mm - Imports

§ 360nn - Inspection, records, and reports

21 U.S. Code § -

§ 360pp - Enforcement

§ 360qq - Repealed.

§ 360rr - Federal-State cooperation

§ 360ss - State standards

§ 360aaa to 360aaa–6 - Omitted

§ 360bbb - Expanded access to unapproved therapies and diagnostics

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 360ccc - Conditional approval of new animal drugs for minor use and minor species

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

§ 363 - Regulations making exemptions

§ 364 - Repealed.

§ 371 - Regulations and hearings

§ 372 - Examinations and investigations

§ 372a - Transferred

§ 373 - Records

§ 374 - Inspection

§ 374a - Inspections relating to food allergens

§ 375 - Publicity

§ 376 - Examination of sea food on request of packer; marking food with results; fees; penalties

§ 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests

§ 378 - Advertising of foods

§ 379 - Confidential information

§ 379a - Presumption of existence of jurisdiction

§ 379b - Consolidated administrative and laboratory facility

§ 379c - Transferred

§ 379d - Automation of Food and Drug Administration

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

§ 379f - Recovery and retention of fees for freedom of information requests

§ 379g - Definitions

§ 379h - Authority to assess and use drug fees

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379i - Definitions

§ 379j - Authority to assess and use device fees

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379k - Information system

21 U.S. Code § -

21 U.S. Code § -

§ 379r - National uniformity for nonprescription drugs

§ 379s - Preemption for labeling or packaging of cosmetics

§ 379v - Safety report disclaimers

§ 379aa - Serious adverse event reporting for nonprescription drugs

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379dd - Establishment and functions of the Foundation

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 381 - Imports and exports

§ 382 - Exports of certain unapproved products

§ 383 - Office of International Relations

§ 384 - Importation of prescription drugs

§ 384a - Foreign supplier verification program

§ 384b - Voluntary qualified importer program

§ 384c - Inspection of foreign food facilities

§ 384d - Accreditation of third-party auditors

§ 387 - Definitions

§ 387a - FDA authority over tobacco products

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 387b - Adulterated tobacco products

§ 387c - Misbranded tobacco products

§ 387d - Submission of health information to the Secretary

§ 387e - Annual registration

§ 387f - General provisions respecting control of tobacco products

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 387g - Tobacco product standards

§ 387h - Notification and other remedies

§ 387i - Records and reports on tobacco products

§ 387j - Application for review of certain tobacco products

§ 387k - Modified risk tobacco products

21 U.S. Code § -

§ 387m - Equal treatment of retail outlets

§ 387n - Jurisdiction of and coordination with the Federal Trade Commission

21 U.S. Code § -

§ 387p - Preservation of State and local authority

§ 387q - Tobacco Products Scientific Advisory Committee

§ 387r - Drug products used to treat tobacco dependence

§ 387s - User fees

§ 387t - Labeling, recordkeeping, records inspection

§ 387u - Studies of progress and effectiveness

§ 391 - Separability clause

§ 392 - Exemption of meats and meat food products

§ 393 - Food and Drug Administration

§ 393a - Office of Pediatric Therapeutics

§ 394 - Scientific review groups

§ 395 - Loan repayment program

§ 396 - Practice of medicine

§ 397 - Contracts for expert review

§ 467f - Federal Food, Drug, and Cosmetic Act applications

§ 679 - Application of Federal Food, Drug, and Cosmetic Act

§ 821 - Rules and regulations

§ 1034 - Inspection of egg products

U.S. Code: Title 28 - JUDICIARY AND JUDICIAL PROCEDURE
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 10 after this date.

  • 2013-12-19; vol. 78 # 244 - Thursday, December 19, 2013
    1. 78 FR 76748 - Citizen Petition Submission; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This final rule is effective December 19, 2013.
      21 CFR Part 10