Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications, 61064 [2019-24513]
Download as PDF
<![CDATA[
61064
Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices
in brackets in the heading of this
document.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
[Docket No. FDA–2009–N–0380]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Product
Jurisdiction: Assignment of Agency
Component for Review of Premarket
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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: Fax written comments on the
collection of information by December
12, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0523. Also
include the FDA docket number found
SUMMARY:
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—21 CFR Part 3
OMB Control Number 0910–0523—
Extension
This regulation relates to Agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), and amended
by the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250), by specifying how FDA will
determine the organizational component
within FDA assigned to have primary
jurisdiction for the premarket review
and regulation of products that are
comprised of any combination of: (1) A
drug and a device; (2) a device and a
biological product; (3) a biological
product and a drug; or (4) a drug, a
device, and a biological product. The
second purpose of this regulation is to
enhance the efficiency of Agency
management and operations by
providing procedures for classifying and
determining which Agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute.
The regulation establishes a
procedure by which an applicant may
obtain an assignment or designation
determination. The regulation requires
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which Agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biological
products and combination products.
The respondents will be businesses or
other for-profit organizations.
In the Federal Register of July 17,
2019 (84 FR 34188), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
3 ...........................................................................................
61
1
61
24
1,464
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 552 hours and a
corresponding decrease of 23 responses/
records. This adjustment is based on the
number of submissions we received
since the last OMB approval.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24513 Filed 11–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0823]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Format and
Content Requirements for Over-theCounter Drug Product Labeling
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
SUMMARY:
VerDate Sep<11>2014
17:47 Nov 08, 2019
Jkt 250001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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).
Fax written comments on the
collection of information by December
12, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
DATES:
E:\FR\FM\12NON1.SGM
12NON1
]]>Agencies
[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Page 61064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24513]
[[Page 61064]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0380]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Product Jurisdiction:
Assignment of Agency Component for Review of Premarket Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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: Fax written comments on the collection of information by
December 12, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0523.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Product Jurisdiction: Assignment of Agency Component for Review of
Premarket Applications--21 CFR Part 3
OMB Control Number 0910-0523--Extension
This regulation relates to Agency management and organization and
has two purposes. The first is to implement section 503(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by
the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by
the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-
250), by specifying how FDA will determine the organizational component
within FDA assigned to have primary jurisdiction for the premarket
review and regulation of products that are comprised of any combination
of: (1) A drug and a device; (2) a device and a biological product; (3)
a biological product and a drug; or (4) a drug, a device, and a
biological product. The second purpose of this regulation is to enhance
the efficiency of Agency management and operations by providing
procedures for classifying and determining which Agency component is
designated to have primary jurisdiction for any drug, device, or
biological product where such jurisdiction is unclear or in dispute.
The regulation establishes a procedure by which an applicant may
obtain an assignment or designation determination. The regulation
requires that the request include the identity of the applicant, a
comprehensive description of the product and its proposed use, and the
applicant's recommendation as to which Agency component should have
primary jurisdiction, with an accompanying statement of reasons. The
information submitted would be used by FDA as the basis for making the
assignment or designation decision. Most information required by the
regulation is already required for premarket applications affecting
drugs, devices, biological products and combination products. The
respondents will be businesses or other for-profit organizations.
In the Federal Register of July 17, 2019 (84 FR 34188), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3.................................................................. 61 1 61 24 1,464
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall decrease of 552 hours and a corresponding decrease of 23
responses/records. This adjustment is based on the number of
submissions we received since the last OMB approval.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24513 Filed 11-8-19; 8:45 am]
BILLING CODE 4164-01-P
