[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,
[email protected].
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
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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]
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