Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information
| Citation | 86 FR 24628 |
| Record Number | 2021-09624 |
| Published date | 07 May 2021 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 87 (Friday, May 7, 2021)
[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24628-24629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09624]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0913]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 513(g) Request for
Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the
collection of information by June 7, 2021.
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 0910-0705. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
513(g) Request for Information
OMB Control Number 0910-0705--Extension
This information collection supports Agency regulations and
accompanying guidance. Section 513(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(g)) provides a means for
obtaining the Agency's views about the classification and regulatory
requirements that may be applicable to a particular device. Section
513(g) provides that, within 60 days of the receipt of a written
request of any person for information respecting the class in which a
device has been classified or the requirements applicable to a device
under the FD&C Act, the Secretary of Health and Human Services shall
provide such person a written statement of the classification (if any)
of such device and the requirements of the FD&C Act applicable to the
device. Regulations governing medical device classification procedures
are codified under 21 CFR part 860.
The guidance document entitled ``FDA and Industry Procedures for
Section 513(g) Requests for Information Under the Federal Food, Drug,
and Cosmetic Act; Guidance for Industry and Food and Drug
Administration Staff'' \1\ establishes procedures for submitting,
reviewing, and responding to requests for information respecting the
class in which a device has been classified or the requirements
applicable to a device under the FD&C Act that are submitted in
accordance with section 513(g) of the FD&C Act. FDA does not review
data related to substantial equivalence or safety and effectiveness in
a 513(g) request for information. FDA's responses to 513(g) requests
for information are not device classification decisions and do not
constitute FDA clearance or approval for marketing. Classification
decisions and clearance or approval for marketing require submissions
under different sections of the FD&C Act.
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\1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.
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Relatedly, the FD&C Act, as amended by the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), requires FDA to
collect user fees for 513(g) requests for information. The guidance
document entitled ``User Fees for 513(g) Requests for Information;
Guidance for Industry and Food and Drug Administration Staff'' \2\
assists FDA staff and regulated industry by describing the user fees
associated with 513(g) requests. The Medical Device User Fee Cover
Sheet (Form FDA 3601), which accompanies the supplemental material
described in this information collection is approved under OMB control
number 0910-0511.
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\2\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-information.
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In the Federal Register of January 13, 2021 (86 FR 2674), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received five comments; however, the
comments
[[Page 24629]]
were not responsive to the information collection.
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
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Center for Devices and 114 1 114 12 1,368
Radiological Health 513(g)
requests.......................
Center for Biologics Evaluation 4 1 4 12 48
and Research 513(g) requests...
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Total....................... .............. .............. .............. .............. 1,416
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: April 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09624 Filed 5-6-21; 8:45 am]
BILLING CODE 4164-01-P
