Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
| Published date | 01 September 2020 |
| Citation | 85 FR 54385 |
| Record Number | 2020-19256 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 85 Issue 170 (Tuesday, September 1, 2020)
[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Page 54385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19256]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1064]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Petitions for
Exemption From Preemption
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: Submit written comments (including recommendations) on the
collection of information by October 1, 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 0910-0277. 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.
State Petitions for Exemption From Preemption--21 CFR 100.1(d)
OMB Control Number 0910-0277--Extension
Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption
from Federal preemption of State food labeling and standard-of-identity
requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the
information a State is required to submit in such a petition. The
information required under Sec. 100.1(d) enables FDA to determine
whether the State food labeling or standard-of-identity requirement
satisfies the criteria of section 403A(b) of the FD&C Act for granting
exemption from Federal preemption.
Description of Respondents: The respondents to this collection of
information are State and local governments who regulate food labeling
and standards of identity.
In the Federal Register of May 22, 2020 (85 FR 31190), we published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1(d)........................................................... 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for Sec. 100.1(d) is minimal because
petitions for exemption from preemption are seldom submitted by States.
In the last 3 years, we have received one new petition for exemption
from preemption; therefore, we estimate that one or fewer petitions
will be submitted annually.
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: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19256 Filed 8-31-20; 8:45 am]
BILLING CODE 4164-01-Ps
