[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29459-29461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6085]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General 
Administrative Practice and Procedures

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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by June 15, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0191. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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.

General Administrative Practice and Procedures

OMB Control Number 0910-0191--Revision

    This information collection supports FDA regulations governing its 
administrative practices and procedures. Although certain information 
collection pertaining to official administrative actions is not subject 
to review by OMB under the PRA in accordance with 44 U.S.C. 
3518(c)(1)(B) (5 CFR 1320.4(a)(2)), we have reviewed our regulations 
and are revising this information collection to include provisions that 
we believe may be subject to OMB review. We are also revising the 
information collection to consolidate related activities discussed in 
Agency guidance, as we believe this will improve the efficiency of our 
operations.
    In the Federal Register of January 9, 2020 (85 FR 1169), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. Although two comments were received, neither was 
directly responsive to the information collection topics solicited. At 
the same time, the comments were supportive of FDA information 
collection activity, and we appreciate this input.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
10.19; request for waiver,                     1               1               1               1               1
 suspension, or modification of
 requirements...................
10.30 and 10.31; citizen                     220               1             220              24           5,280
 petitions and petitions related
 to ANDA,\2\ certain NDAs,\3\ or
 certain BLAs \4\...............
10.33; administrative                          6               1               6              10              60
 reconsideration of action......
10.35; administrative stay of                  5               1               5              10              50
 action.........................
10.65; meetings and                          750               1             750               5           3,750
 correspondence.................
10.85; requests for Advisory                   4               1               4              16              64
 opinions.......................
10.115(f)(3); submitting draft               100               1             100               4             400
 guidance proposals.............

[[Page 29460]]

 
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
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    Total.......................  ..............  ..............           1,096  ..............           9,720
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Abbreviated new drug applications.
\3\ New drug applications.
\4\ Biologic license applications.

    Unless a waiver, suspension, or modification submitted under Sec.  
10.19 (21 CFR 10.19) is granted by the Commissioner of Food and Drugs 
(the Commissioner), the regulations in 21 CFR part 10 apply to all 
petitions, hearings, and other administrative proceedings and 
activities conducted by FDA. Because we have not received requests 
under Sec.  10.19, we had not included this provision in the 
information collection. However, to reflect the attendant burden 
resulting from submitting such a request, we provide an estimate of 1 
response and 1 burden hour annually.
    Administrative proceedings may be initiated under Sec.  10.25 (21 
CFR 10.25) when a petition is submitted. Section 10.30 (21 CFR 10.30) 
sets forth procedures by which an interested person may submit 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. Similarly, Sec.  10.31 (21 CFR 10.31) governs 
citizen petitions and petitions for stay of action related to 
abbreviated new drug applications, certain new drug applications, or 
certain biologics license applications issued under section 701(a) of 
the Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
371(a)). The regulations provide content, format, and procedural 
requirements applicable to the submission of these petitions. To assist 
respondents to the information collection, FDA's Center for Drug 
Evaluation and Research developed an interpretive guidance entitled 
``Citizen Petitions and Petitions for Stay of Action Subject to Section 
505(q) of the Federal Food, Drug, and Cosmetic Act.'' The guidance 
describes FDA's current thinking on interpreting section 505(q) of the 
FD&C Act (21 U.S.C. 355(q)), and is currently approved under OMB 
control number 0910-0679. Based on Agency data, an average of 220 
citizen petitions are received annually under Sec. Sec.  10.30 and 
10.31, and we estimate an average of 24 hours is required to prepare 
such a petition, for a total of 5,280 hours annually.
    The regulations also establish a means by which an interested 
person may request that part or all of a decision by the Commissioner 
be reconsidered, or that the effective date of an action be stayed or 
extended. Sections 10.33 and 10.35 (21 CFR 10.33 and 10.35) establish 
the content, format, and procedural requirements applicable to such 
requests and explain that they must be submitted no later than 30 days 
after the decision involved. The regulations provide alternatively 
that, for good cause, the Commissioner may permit a petition to be 
filed after 30 days. The regulations also explain that 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. According to our records, we have received a total of 12 
such requests and we assume it takes respondents an average of 10 hours 
to prepare.
    Section 10.65 (21 CFR 10.65) covers Agency meetings and 
correspondence. Interested persons may hold meetings and exchange 
correspondence with FDA representatives on matters within its 
jurisdiction by following the instructions and providing the 
information described in Sec.  10.65. Because FDA maintains other 
information collections in its inventory that cover specific types of 
meeting requests, we did not previously include burden that may result 
from this section. However, to account for burden associated with 
meeting requests and correspondence generally, we provide an estimate 
of 750 submissions annually under this information collection; we 
assume one respondent per submission; and we assume each submission 
requires respondents between 1 to 10 hours to prepare, including 
gathering and reviewing the necessary material. We therefore use an 
average of 5 hours for this estimate and base this estimate on our 
experience with similar information collection.
    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
FD&C Act, sets forth content, format, and procedural requirements by 
which an interested person may request an advisory opinion from the 
Commissioner on a matter of general applicability. The regulation 
explains that, 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. Based on Agency data, we estimate four such requests 
are received each year, and we assume each request requires 16 hours to 
prepare, for a total of 64 hours annually.
    Section 10.115(f)(3) (21 CFR 10.115(f)(3)) provides for the public 
submission of draft guidance documents or topics for development to our 
Dockets Management Staff. To participate in the development and 
issuance of guidance documents, the public may elect to submit comment 
through alternative mechanisms as explained in our Good Guidance 
Practice regulations under Sec.  10.115. Although most submissions and 
attendant burden associated with recommendations found in Agency 
guidance is accounted for in individual information collections 
associated with a particular product area or regulatory topic, here we 
are accounting for burden associated with general public submissions as 
described in Sec.  10.115(f)(3). Based on Agency data, we receive an 
average of 100 such submissions each year; we assume each submission 
requires an average of 4 hours to prepare and, therefore, calculate a 
total burden of 400 hours annually.
    Regulations in Sec.  12.20 (21 CFR 12.20) include information 
collection associated with requesting a formal evidentiary public 
hearing and are issued under section 701(e)(2) of the

[[Page 29461]]

FD&C Act. The regulations provide instructions for filing objections 
and requests for a hearing on a regulation or order under Sec.  
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. 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. We estimate 
five respondents will file a request under the regulation and assume 
each request requires 20 hours to prepare, for a total of 100 hours 
annually.
    Finally, Sec.  12.45 (21 CFR 12.45), issued under section 701 of 
the FD&C Act, sets forth content, format, and procedural requirements 
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. 
Based on our records, we estimate five filings under this regulation 
and assume it requires 3 hours to prepare, for a total of 15 hours 
annually.
    Respondents to the information collection are those interested 
persons conducting business with FDA, and thus subject to the 
applicable administrative regulations.
    The burden estimates for this collection of information are based 
on Agency records and our experience over the past 3 years. By revising 
the information collection to include additional provisions, we have 
increased our annual burden estimate by 869 responses and 1,096 hours.

    Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10384 Filed 5-14-20; 8:45 am]
BILLING CODE 4164-01-P


