[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30736-30738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2029]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Administrative 
Practices and Procedures; Formal Evidentiary Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
30, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#d8b7b1aab987abadbab5b1ababb1b7b698b7b5baf6bdb7a8f6bfb7ae"><span class="__cf_email__" data-cfemail="2f40465d4e705c5a4d42465c5c4640416f40424d014a405f01484059">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0191. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#d282809381a6b3b4b492b4b6b3fcbabaa1fcb5bda4"><span class="__cf_email__" data-cfemail="227270637156434444624446430c4a4a510c454d54">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Administrative Practices and Procedures; Formal Evidentiary Public 
Hearing

OMB Control Number 0910-0191--Extension

    The Administrative Procedures Act (5 U.S.C. 553(e)) provides that 
every Agency shall give an interested person the right to petition for 
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) 
sets forth the format and procedures by which an interested person may 
submit to FDA, in accordance with Sec.  10.20 (21 CFR 10.20), a citizen 
petition requesting the Commissioner of Food and Drugs (the 
Commissioner) to issue, amend, or revoke a regulation or order, or to 
take or refrain from taking any other form of administrative action.
    The Commissioner may grant or deny such a petition, in whole or in 
part, and may grant such other relief or take other action as the 
petition warrants. Respondents are individuals or households, State or 
local governments, and not-for-profit institutions or groups.
    Section 10.33 (21 CFR 10.33), issued under section 701(a) of the 
Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)), 
sets forth the format and procedures by which an interested person may 
request reconsideration of part or all of a decision of the 
Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of 
administrative proceedings). A petition for reconsideration must 
contain a full statement in a well-organized format of the factual and 
legal grounds upon which the petition relies. The grounds must 
demonstrate that relevant information and views contained in the 
administrative record were not previously or not adequately considered 
by the Commissioner. The respondent must submit a petition no later 
than 30 days after the decision involved. However, the Commissioner 
may, for good cause, permit a petition to be filed after 30 days. An 
interested person who wishes to rely on information or views not 
included in the administrative record shall submit them with a new 
petition to modify the decision. FDA uses the information provided in 
the request to determine whether to grant

[[Page 30737]]

the petition for reconsideration. Respondents to this collection of 
information are individuals of households, State or local governments, 
not-for-profit institutions, and businesses or other for-profit 
institutions who are requesting from the Commissioner of FDA a 
reconsideration of a matter.
    Section 10.35 (21 CFR 10.35), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20, the Commissioner to 
stay the effective date of any administrative action.
    Such a petition must do the following: (1) Identify the decision 
involved; (2) state the action requested, including the length of time 
for which a stay is requested; and (3) include a statement of the 
factual and legal grounds on which the interested person relies in 
seeking the stay. FDA uses the information provided in the request to 
determine whether to grant the petition for stay of action.
    Respondents to this information collection are interested persons 
who choose to file a petition for an administrative stay of action.
    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20, an advisory opinion 
from the Commissioner on a matter of general applicability. When making 
a request, the petitioner must provide a concise statement of the 
issues and questions on which an opinion is requested, and a full 
statement of the facts and legal points relevant to the request. 
Respondents to this collection of information are interested persons 
seeking an advisory opinion from the Commissioner.
    FDA has developed a method for electronic submission of citizen 
petitions. The Agency still allows for non-electronic submissions; 
however, electronic submissions of a citizen petition to a specific 
electronic docket presents a simpler and more straightforward approach. 
FDA has created a single docket on https://www.regulations.gov, the 
U.S. Government's consolidated docket website for Federal Agencies, for 
the initial electronic submission of all citizen petitions. The 
advantage to this is that it ensures efficiency and ease in 
communication, quicker interaction between citizen petitioners and FDA, 
and easier access to FDA to seek input through the citizen petition 
process.
    The regulations in 21 CFR 12.22, issued under section 701(e)(2) of 
the FD&C Act, set forth the instructions for filing objections and 
requests for a hearing on a regulation or order under Sec.  12.20(d) 
(21 CFR 12.20(d)). Objections and requests must be submitted within the 
time specified in Sec.  12.20(e). Each objection, for which a hearing 
has been requested, must be separately numbered and specify the 
provision of the regulation or the proposed order. In addition, each 
objection must include a detailed description and analysis of the 
factual information and any other document, with some exceptions, 
supporting the objection. Failure to include this information 
constitutes a waiver of the right to a hearing on that objection. FDA 
uses the description and analysis to determine whether a hearing 
request is justified. The description and analysis may be used only for 
the purpose of determining whether a hearing has been justified under 
21 CFR 12.24 and does not limit the evidence that may be presented if a 
hearing is granted.
    Respondents to this information collection are those parties that 
may be adversely affected by an order or regulation.
    Section 12.45 (21 CFR 12.45), issued under section 701 of the FD&C 
Act, sets forth the format and procedures for any interested person to 
file a petition to participate in a formal evidentiary hearing, either 
personally or through a representative. Section 12.45 requires that any 
person filing a notice of participation state their specific interest 
in the proceedings, including the specific issues of fact about which 
the person desires to be heard. This section also requires that the 
notice include a statement that the person will present testimony at 
the hearing and will comply with specific requirements in 21 CFR 12.85, 
or, in the case of a hearing before a Public Board of Inquiry, 
concerning disclosure of data and information by participants (21 CFR 
13.25). In accordance with Sec.  12.45(e) the presiding officer may 
omit a participant's appearance.
    The presiding officer and other participants will use the collected 
information in a hearing to identify specific interests to be 
presented. This preliminary information serves to expedite the 
prehearing conference and commits participation.
    The respondents are individuals or households, State or local 
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
    In the Federal Register of February 22, 2018 (83 FR 7742), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
10.30--Citizen petition.........             220               1             220              24           5,280
10.33--Administrative                          6               1               6              10              60
 reconsideration of action......
10.35--Administrative stay of                  6               1               5              10              50
 action.........................
10.85--Requests for Advisory                   4               1               4              16              64
 opinions.......................
12.22--Filing objections and                   5               1               5              20             100
 requests for a hearing on a
 regulation or order............
12.45--Notice of participation..               5               1               5               3              15
    Total.......................  ..............  ..............  ..............  ..............           5,569
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\1.\There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for this collection of information are based 
on Agency records and experience over the past 3 years. The increase in 
burden hours is due to an increase in the number of respondents under 
several provisions.


[[Page 30738]]


    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14058 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


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