[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73320-73322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements 
contained in current FDA regulations: Administrative Practices and 
Procedures; Formal Evidentiary Public Hearing.

DATES: Submit either electronic or written comments on the collection 
of information by February 9, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.

[[Page 73321]]

    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35, 
10.85); Formal Evidentiary Public Hearing (21 CFR 12.22, 12.45) (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) 
(Submission of documents to Division of Dockets Management), a citizen 
petition requesting 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 (the 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 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 (Submission of 
documents to Division of Dockets Management), 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 (Submission of 
documents to Division of Dockets Management), an advisory opinion from 
the Commissioner on a matter of general applicability. An advisory 
opinion represents the formal position of FDA 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 on 
the Agency's formal position for matters of general applicability.
    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 http://www.regulations.gov, the U.S. 
Government's consolidated docket Web site for Federal Agencies, for the 
initial electronic submission of all citizen petitions. The advantage 
to this change 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 (21 U.S.C. 371(e)(2)), 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 (21 U.S.C. 371), 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

[[Page 73322]]

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.
    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
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10.30_Citizen Petition..........             207               1             207              24           4,968
10.33_Administrative                           4               1               4              10              40
 reconsideration of action......
10.35_Administrative Stay of                   5               1               5              10              50
 Action.........................
10.85_Advisory Opinions.........               4               1               4              16              64
12.22_Filing Objections and                    3               1               3              20              60
 Requests for a Hearing on a
 Regulation or Order............
12.45_Notice of Participation...               4               1               4               3              12
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    Total.......................  ..............  ..............  ..............  ..............           5,194
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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.

    Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28825 Filed 12-9-14; 8:45 am]
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