[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.20]

[Page 110-112]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10_ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
               Subpart B_General Administrative Procedures
 
Sec. 10.20  Submission of documents to Division of Dockets Management; 
computation of time; availability for public disclosure.


    (a) A submission to the Division of Dockets Management of a 
petition, comment, objection, notice, compilation of information, or any 
other document is to be filed in four copies except as otherwise 
specifically provided in a relevant Federal Register notice or in 
another section of this chapter. The Division of Dockets Management is 
the agency custodian of these documents.
    (b) A submission is to be signed by the person making it, or by an 
attorney or other authorized representative of that person. Submissions 
by trade associations are also subject to the requirements of Sec. 
10.105(b).
    (c) Information referred to or relied upon in a submission is to be 
included in full and may not be incorporated by reference, unless 
previously submitted in the same proceeding.
    (1) A copy of an article or other reference or source cited must be 
included, except where the reference or source is:
    (i) A reported Federal court case;
    (ii) A Federal law or regulation;
    (iii) An FDA document that is routinely publicly available; or
    (iv) A recognized medical or scientific textbook that is readily 
available to the agency.
    (2) If a part of the material submitted is in a foreign language, it 
must be accompanied by an English translation verified to be complete 
and accurate, together with the name, address, and a brief statement of 
the qualifications of the person making the translation. A translation 
of literature or other material in a foreign language is to be 
accompanied by copies of the original publication.
    (3) Where relevant information is contained in a document also 
containing irrelevant information, the irrelevant information is to be 
deleted and only the relevant information is to be submitted.
    (4) Under Sec. 20.63 (a) and (b), the names and other information 
that would identify patients or research subjects are to be deleted from 
any record before it is submitted to the Division of Dockets Management 
in order to preclude a clearly unwarranted invasion of personal privacy.
    (5) Defamatory, scurrilous, or intemperate matter is to be deleted 
from a record before it is submitted to the Division of Dockets 
Management.
    (6) The failure to comply with the requirements of this part or with 
Sec. 12.80 or Sec. 13.20 will result in rejection of the submission 
for filing or, if it is filed, in exclusion from consideration of any 
portion that fails to comply. If a submission fails to meet any 
requirement of this section and the deficiency becomes known to the 
Division of Dockets Management, the Division of Dockets Management shall 
not file the submission but return it with a copy of the applicable 
regulations indicating those provisions not complied with. A deficient 
submission may be corrected or supplemented and subsequently filed. The 
office of the Division of Dockets Management does not make decisions 
regarding the confidentiality of submitted documents.
    (d) The filing of a submission means only that the Division of 
Dockets Management has identified no technical deficiencies in the 
submission. The filing of a petition does not mean or imply

[[Page 111]]

that it meets all applicable requirements or that it contains reasonable 
grounds for the action requested or that the action requested is in 
accordance with law.
    (e) All submissions to the Division of Dockets Management will be 
considered as submitted on the date they are postmarked or, if delivered 
in person during regular business hours, on the date they are delivered, 
unless a provision in this part, an applicable Federal Register notice, 
or an order issued by an administrative law judge specifically states 
that the documents must be received by a specified date, e.g., Sec. 
10.33(g) relating to a petition for reconsideration, in which case they 
will be considered submitted on the date received.
    (f) All submissions are to be mailed or delivered in person to the 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
    (g) FDA ordinarily will not acknowledge or give receipt for 
documents, except:
    (1) Documents delivered in person or by certified or registered mail 
with a return receipt requested; and
    (2) Petitions for which acknowledgment of receipt of filing is 
provided by regulation or by customary practice, e.g., Sec. 10.30(c) 
relating to a citizen petition.
    (h) Saturdays, Sundays, and Federal legal holidays are included in 
computing the time allowed for the submission of documents, except that 
when the time for submission expires on a Saturday, Sunday, or Federal 
legal holiday, the period will be extended to include the next business 
day.
    (i) All submissions to the Division of Dockets Management are 
representations that, to the best of the knowledge, information, and 
belief of the person making the submission, the statements made in the 
submission are true and accurate. All submissions are subject to the 
False Reports to the Government Act (18 U.S.C. 1001) under which a 
willfully false statement is a criminal offense.
    (j) The availability for public examination and copying of 
submissions to the Division of Dockets Management is governed by the 
following rules:
    (1) Except to the extent provided in paragraphs (j)(2) and (3) of 
this section, the following submissions, including all supporting 
material, will be on public display and will be available for public 
examination between 9 a.m. and 4 p.m., Monday through Friday. Requests 
for copies of submissions will be filed and handled in accordance with 
subpart C of part 20:
    (i) Petitions.
    (ii) Comments on petitions, on documents published in the Federal 
Register, and on similar public documents.
    (iii) Objections and requests for hearings filed under part 12.
    (iv) Material submitted at a hearing under Sec. 12.32(a)(2) and 
parts 12, 13, and 15.
    (v) Material placed on public display under the regulations in this 
chapter, e.g., agency guidance documents developed under Sec. 10.115.
    (2)(i) Material prohibited from public disclosure under Sec. 20.63 
(clearly unwarranted invasion of personal privacy) and, except as 
provided in paragraph (j)(3) of this section, material submitted with 
objections and requests for hearing filed under part 12, or at a hearing 
under part 12 or part 13, or an alternative form of public hearing 
before a public advisory committee or a hearing under Sec. 12.32(a) (2) 
or (3), of the following types will not be on public display, will not 
be available for public examination, and will not be available for 
copying or any other form of verbatim transcription unless it is 
otherwise available for public disclosure under part 20:
    (a) Safety and effectiveness information, which includes all studies 
and tests of an ingredient or product on animals and humans and all 
studies and tests on the ingredient or product for identity, stability, 
purity, potency, bioavailability, performance, and usefulness.
    (b) A protocol for a test or study.
    (c) Manufacturing methods or processes, including quality control 
procedures.
    (d) Production, sales distribution, and similar information, except 
any compilation of information aggregated and prepared in a way that 
does not reveal confidential information.

[[Page 112]]

    (e) Quantitative or semiquantitative formulas.
    (f) Information on product design or construction.
    (ii) Material submitted under paragraph (j)(2) of this section is to 
be segregated from all other submitted material and clearly so marked. A 
person who does not agree that a submission is properly subject to 
paragraph (j)(2) may request a ruling from the Associate Commissioner 
for Public Affairs whose decision is final, subject to judicial review 
under Sec. 20.48.
    (3) Material listed in paragraph (j)(2)(i) (a) and (b) of this 
section may be disclosed under a protective order issued by the 
administrative law judge or other presiding officer at a hearing 
referenced in paragraph (j)(2)(i). The administrative law judge or 
presiding officer shall permit disclosure of the data only in camera and 
only to the extent necessary for the proper conduct of the hearing. The 
administrative law judge or presiding officer shall direct to whom the 
information is to be made available (e.g., to parties or participants, 
or only to counsel for parties or participants), and persons not 
specifically permitted access to the data will be excluded from the in 
camera part of the proceeding. The administrative law judge or other 
presiding officer may impose other conditions or safeguards. The limited 
availability of material under this paragraph does not constitute prior 
disclosure to the public as defined in Sec. 20.81, and no information 
subject to a particular order is to be submitted to or received or 
considered by FDA in support of a petition or other request from any 
other person.

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 49 
FR 7363, Feb. 29, 1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28, 
1994; 64 FR 69190, Dec. 10, 1999; 65 FR 56477, Sept. 19, 2000; 66 FR 
56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12, 
2003]