Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling, 61064-61065 [2019-24509]
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
61065
Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices
OMB control number 0910–0340. 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.
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:
Format and Content Requirements for
Over-the-Counter Drug Product
Labeling—21 CFR Part 201
OMB Control Number 0910–0340—
Extension
This information collection supports
FDA regulations at § 201.66 (21 CFR
201.66), which establish standardized
content and format requirements for the
labeling of all marketed over-thecounter (OTC) drug products. The
regulations set forth the content and
format requirements for the Drug Facts
portion of labels on OTC drug products.
These regulations require OTC drug
product labeling to include uniform
headings and subheadings, presented in
a standardized order, with minimum
standards for type size and other
graphical features.
Currently marketed OTC drug
products are already required to comply
with these labeling requirements and
will incur no further burden to comply
with Drug Facts labeling requirements
in § 201.66. Labeling modifications
already required to be in Drug Facts
format are ‘‘usual and customary’’ as
part of routine redesign practice, thus
they do not create additional burden
within the meaning of the PRA.
Therefore, burden for this information
collection is that which is necessary to
comply with the labeling requirements
in § 201.66, applicable to new OTC drug
products and OTC sunscreen drug
products introduced to the marketplace
under new drug applications,
abbreviated new drug applications, or
an OTC drug monograph. New OTC
drug products must comply with the
labeling requirements in § 201.66 as
they are introduced to the marketplace.
Based on our electronic drug
registration and listing database, we
estimate that approximately 10,463 new
OTC drug product stock keeping units
(SKUs) are introduced to the
marketplace each year. We estimate that
these SKUs are marketed by 1,416
manufacturers. We estimate that the
preparation of labeling for new OTC
drug products requires 12 hours to
prepare, complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is 94,296
hours.
All currently marketed sunscreen
products are required to comply with
the Drug Facts labeling requirements in
§ 201.66, so they will incur no further
burden under the information collection
provisions in the regulation. However, a
new OTC sunscreen drug product, like
any new OTC drug product, will be
subject to a one-time burden to comply
with Drug Facts labeling requirements
in § 201.66. We estimate, based on our
electronic drug registration and listing
database, that 5,253 new SKUs of OTC
sunscreen drug products will be
marketed each year. We estimate that
these 5,253 SKUs will be marketed by
294 manufacturers. We estimate that 12
hours will be spent on each label. This
is reflected in table 1, row 1.
When determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e). We
receive very few requests for
exemptions or deferrals. We also
estimate that a request for deferral or
exemption requires 24 hours to
complete. This is reflected in table 1,
row 2.
In the Federal Register of June 19,
2019 (84 FR 28555), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
from a trade organization representing
nurse practitioners. The comment
advocated revising FDA regulations to
provide for provider-neutral language in
Agency regulations but acknowledged
its use in current Agency guidance. We
appreciate this comment, but we decline
to adopt the suggestion at this time.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
§ 201.66(c) and (d) for new OTC drug products .................
§ 201.66(e) ...........................................................................
855
1
9.19
1
7,858
1
12
24
94,296
24
Total ..............................................................................
........................
........................
........................
........................
94,320
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 increase of 82,797 hours and a
corresponding increase of 6,898
disclosures. This increase corresponds
with data obtained from our database.
Dated: October 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24509 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–2019–N–4777]
Haemonetics Manufacturing, Inc.;
Withdrawal of Approval of Abbreviated
New Drug Application of Anticoagulant
Citrate Dextrose Solution A, USP
AGENCY:
ACTION:
VerDate Sep<11>2014
17:47 Nov 08, 2019
Food and Drug Administration,
HHS.
Jkt 250001
PO 00000
Notice.
Frm 00061
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of abbreviated
new drug application (ANDA) BA
710497/0 for Anticoagulant Citrate
Dextrose Solution A, USP (ACD–A), In
Plastic Bags, held by Haemonetics
Manufacturing, Inc. Haemonetics
Manufacturing, Inc., requested in
writing that the Agency’s approval of
the application be withdrawn because
the drug is no longer being marketed
and has waived its opportunity for a
hearing.
SUMMARY:
E:\FR\FM\12NON1.SGM
12NON1
]]>Agencies
[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61064-61065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24509]
-----------------------------------------------------------------------
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-the-Counter Drug Product Labeling
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (PRA).
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
[[Page 61065]]
OMB control number 0910-0340. 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.
Format and Content Requirements for Over-the-Counter Drug Product
Labeling--21 CFR Part 201
OMB Control Number 0910-0340--Extension
This information collection supports FDA regulations at Sec.
201.66 (21 CFR 201.66), which establish standardized content and format
requirements for the labeling of all marketed over-the-counter (OTC)
drug products. The regulations set forth the content and format
requirements for the Drug Facts portion of labels on OTC drug products.
These regulations require OTC drug product labeling to include uniform
headings and subheadings, presented in a standardized order, with
minimum standards for type size and other graphical features.
Currently marketed OTC drug products are already required to comply
with these labeling requirements and will incur no further burden to
comply with Drug Facts labeling requirements in Sec. 201.66. Labeling
modifications already required to be in Drug Facts format are ``usual
and customary'' as part of routine redesign practice, thus they do not
create additional burden within the meaning of the PRA.
Therefore, burden for this information collection is that which is
necessary to comply with the labeling requirements in Sec. 201.66,
applicable to new OTC drug products and OTC sunscreen drug products
introduced to the marketplace under new drug applications, abbreviated
new drug applications, or an OTC drug monograph. New OTC drug products
must comply with the labeling requirements in Sec. 201.66 as they are
introduced to the marketplace.
Based on our electronic drug registration and listing database, we
estimate that approximately 10,463 new OTC drug product stock keeping
units (SKUs) are introduced to the marketplace each year. We estimate
that these SKUs are marketed by 1,416 manufacturers. We estimate that
the preparation of labeling for new OTC drug products requires 12 hours
to prepare, complete, and review prior to submitting the new labeling
to us. Based on this estimate, the annual reporting burden for this
type of labeling is 94,296 hours.
All currently marketed sunscreen products are required to comply
with the Drug Facts labeling requirements in Sec. 201.66, so they will
incur no further burden under the information collection provisions in
the regulation. However, a new OTC sunscreen drug product, like any new
OTC drug product, will be subject to a one-time burden to comply with
Drug Facts labeling requirements in Sec. 201.66. We estimate, based on
our electronic drug registration and listing database, that 5,253 new
SKUs of OTC sunscreen drug products will be marketed each year. We
estimate that these 5,253 SKUs will be marketed by 294 manufacturers.
We estimate that 12 hours will be spent on each label. This is
reflected in table 1, row 1.
When determining the burden for Sec. 201.66, it is also important
to consider exemptions or deferrals of the regulation allowed products
under Sec. 201.66(e). We receive very few requests for exemptions or
deferrals. We also estimate that a request for deferral or exemption
requires 24 hours to complete. This is reflected in table 1, row 2.
In the Federal Register of June 19, 2019 (84 FR 28555), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received from a trade
organization representing nurse practitioners. The comment advocated
revising FDA regulations to provide for provider-neutral language in
Agency regulations but acknowledged its use in current Agency guidance.
We appreciate this comment, but we decline to adopt the suggestion at
this time.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden
21 CFR section respondents per disclosures per disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
Sec. 201.66(c) and (d) for new 855 9.19 7,858 12 94,296
OTC drug products..............
Sec. 201.66(e)................ 1 1 1 24 24
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 94,320
----------------------------------------------------------------------------------------------------------------
\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 increase of 82,797 hours and a corresponding increase of 6,898
disclosures. This increase corresponds with data obtained from our
database.
Dated: October 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24509 Filed 11-8-19; 8:45 am]
BILLING CODE 4164-01-P
