Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 58776-58777 [2018-25352]
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58776
Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
copies total. One copy will include the
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with a heading or cover note that states
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will review this copy, including the
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and other applicable disclosure law. For
more information about FDA’s posting
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the information at: https://www.gpo.gov/
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FOR FURTHER INFORMATION CONTACT:
Mabel Lee, Center Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2371.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 28, 2018
(83 FR 49103), FDA published a notice
with a 60-day comment period inviting
interested parties to provide information
on specific topics related to the labeling
of plant-based products with names that
include the names of dairy foods such
as ‘‘milk,’’ ‘‘cultured milk,’’ ‘‘yogurt,’’
and ‘‘cheese.’’ The information will
inform our development of an approach
to the labeling of plant-based products
that consumers may substitute for dairy
foods. We asked that comments be
submitted by November 27, 2018.
We have received requests for a 120day extension of the comment period for
the notice. The requests conveyed
concern that the current 60-day
comment period does not allow
sufficient time to develop meaningful or
thoughtful responses to the questions
VerDate Sep<11>2014
16:08 Nov 20, 2018
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that appeared in the notice requesting
data and other evidence in support of
answers.
We have considered the requests and
are extending the comment period for
another 60 days, until January 28, 2019.
We believe that a 60-day extension
allows adequate time for interested
persons to submit comments without
significantly delaying any potential
further action on these important issues.
Dated: November 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–25347 Filed 11–20–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0500]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions; Requirements on Content
and Format of Labeling for Human
Prescription Drug and Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Fax written comments on the
collection of information by December
21, 2018.
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 0910–0572. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
PO 00000
Frm 00022
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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:
Requirements on Content and Format of
Labeling for Human Prescription Drug
and Biological Products
OMB Control Number 0910–0572—
Extension
FDA’s regulations governing the
content and format of labeling for
human prescription drug and biological
products were revised in the Federal
Register of January 24, 2006 (71 FR
3922) (the 2006 labeling rule) to require
that the labeling of new and recently
approved products contain highlights of
prescribing information, a table of
contents for prescribing information,
reordering of certain sections, minor
content changes, and minimum
graphical requirements. These revisions
were intended to make it easier for
health care practitioners to access, read,
and use information in prescription
drug labeling; to enhance the safe and
effective use of prescription drug
products; and to reduce the number of
adverse reactions resulting from
medication errors because of
misunderstood or incorrectly applied
drug information.
Currently, § 201.56 (21 CFR 201.56)
requires that prescription drug labeling
contain certain information in the
format specified in either § 201.57 (21
CFR 201.57) or § 201.80 (21 CFR
201.80), depending on when the drug
was approved for marketing. Section
201.56(a) sets forth general labeling
requirements applicable to all
prescription drugs. Section 201.56(b)
specifies the categories of new and more
recently approved prescription drugs
subject to the revised content and
format requirements in §§ 201.56(d) and
201.57. Section 201.56(c) sets forth the
schedule for implementing these revised
content and format requirements.
Section 201.56(e) specifies the sections
and subsections, required and optional,
for the labeling of older prescription
drugs not subject to the revised format
and content requirements.
Section 201.57(a) requires that
prescription drug labeling for new and
more recently approved prescription
drug products include a ‘‘Highlights of
Prescribing Information’’ section. The
‘‘Highlights’’ section provides a concise
extract of the most important
information required under § 201.57(c)
(the Full Prescribing Information (FPI)),
as well as certain additional information
important to prescribers. Section
201.57(b) requires a table of contents to
E:\FR\FM\21NON1.SGM
21NON1
Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
prescribing information entitled ‘‘Full
Prescribing Information: Contents,’’
consisting of a list of each heading and
subheading along with its identifying
number to facilitate health care
practitioners’ use of labeling
information. Section 201.57(c) specifies
the contents of the FPI. Section
201.57(d) mandates the minimum
specifications for the format of
prescription drug labeling and
establishes minimum requirements for
key graphic elements such as bold type,
bullet points, type size, and spacing.
Older drugs not subject to the revised
labeling content and format
requirements in § 201.57 are subject to
labeling requirements at § 201.80.
Section 201.80(f)(2) requires that, within
1 year, any FDA-approved patient
labeling be referenced in the
‘‘Precautions’’ section of the labeling of
older products and either accompany or
be reprinted immediately following the
labeling.
Annual Burden for Prescription Drug
Labeling Design, Testing, and
Submitting to FDA for New Drug
Applications (NDAs) and Biologics
License Applications (BLAs) (§§ 201.56
and 201.57)
New drug product applicants must:
(1) Design and create prescription drug
labeling containing ‘‘Highlights,’’
‘‘Contents,’’ and FPI; (2) test the
designed labeling (e.g., to ensure that
the designed labeling fits into cartonenclosed products); and (3) submit it to
FDA for approval. Based on the
projected data used in the January 24,
2006, final rule, FDA estimates that it
will take applicants approximately
2,327 hours to design, test, and submit
prescription drug labeling to FDA as
part of a NDA or a BLA under the
58777
revised regulations. Currently,
approximately 406 applicants submit
approximately 541 new applications
(NDAs and BLAs) to FDA annually,
totaling 1,258,907 hours.
In the Federal Register of July 20,
2018 (83 FR 34596), we published a 60day notice requesting public comment
on the proposed collection of
information. We received two
comments. One comment encouraged
the use of ‘‘provider-neutral language’’
in specific regulations. The second
comment discussed the distribution of
package inserts for prescription drugs
via paper labeling. Because these
comments do not apply to the
regulations associated with the
information collection, we have not
addressed them here.
Our estimate of the burden for the
information collection is as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part and activity
Number of
respondents
Number of
responses per
respondent 2
Total annual
responses
Average
burden per
response
Total hours
Labeling Requirements in §§ 201.56 and 201.57 ................
406
1.332
541
2,327
1,258,907
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
2 Estimates
Our estimated burden for the
information collection reflects an
overall increase of 602,503 hours and a
corresponding increase of 345 records.
We attribute this adjustment to an
increase in the number of submissions
we received over the last few years.
Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–25352 Filed 11–20–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Advisory
Committee on Blood and Tissue Safety
and Availability
Office of HIV/AIDS and
Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
khammond on DSK30JT082PROD with NOTICES
AGENCY:
Notice.
The Department of Health and
Human Services is hereby giving notice
that the charter for the Advisory
Committee on Blood and Tissue Safety
and Availability (ACBTSA) has been
renewed.
SUMMARY:
VerDate Sep<11>2014
16:08 Nov 20, 2018
ACBTSA
is a non-discretionary Federal advisory
committee. ACBTSA is authorized
under 42 U.S.C. 217a, Section 222 of the
Public Health Service (PHS) Act, as
amended. The Committee is governed
by the provisions of the Federal
Advisory Committee Act (FACA), Public
Law 92–463, as amended (5 U.S.C.
App), which sets forth standards for the
formation and use of advisory
committees.
The ACBTSA advises, assists,
consults with, and makes policy
recommendations to the Secretary,
through the Assistant Secretary for
Health, regarding these broad
responsibilities related to the safety of
blood, blood products, tissues, and
organs. For solid organs and blood stem
cells, the Committee’s work is limited to
policy issues related to donor derived
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
ACTION:
Mr.
James Berger, Designated Federal Officer
for the ACBTSA, Senior Advisor for
Blood and Tissue Policy, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, Mary E. Switzer Building, 330
C Street SW, Suite L100, Washington,
DC 20024. Phone: (202) 795–7697; Fax:
(202) 691–2102; Email: ACBTSA@
hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Jkt 247001
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Frm 00023
Fmt 4703
Sfmt 4703
infectious disease complications of
transplantation.
To carry out its mission, the ACBTSA
provides advice to the Secretary through
the Assistant Secretary for Health on a
range of policy issues to include: (1)
Identification of public health issues
through surveillance of blood and tissue
safety issues with national biovigilance
data tools; (2) identification of public
health issues that affect availability of
blood, blood products, and tissues; (3)
broad public health, ethical, and legal
issues related to the safety of blood,
blood products, and tissues; (4) the
impact of various economic factors (e.g.,
product cost and supply) on safety and
availability of blood, blood products,
and tissues; (5) risk communications
related to blood transfusion and tissue
transplantation; and (6) identification of
infectious disease transmission issues
for blood, organs, blood stem cells and
tissues.
On September 25, 2018, the Secretary
approved for the ACBTSA charter to be
renewed. The new charter was effected
and filed with the appropriate
Congressional committees and the
Library of Congress on October 9, 2018.
Renewal of the Committee’s charter
gives authorization for the Committee to
continue to operate until October 9,
2020.
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58776-58777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25352]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0500]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Licensing
Provisions; Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products
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: Fax written comments on the collection of information by
December 21, 2018.
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 0910-0572.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products
OMB Control Number 0910-0572--Extension
FDA's regulations governing the content and format of labeling for
human prescription drug and biological products were revised in the
Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling
rule) to require that the labeling of new and recently approved
products contain highlights of prescribing information, a table of
contents for prescribing information, reordering of certain sections,
minor content changes, and minimum graphical requirements. These
revisions were intended to make it easier for health care practitioners
to access, read, and use information in prescription drug labeling; to
enhance the safe and effective use of prescription drug products; and
to reduce the number of adverse reactions resulting from medication
errors because of misunderstood or incorrectly applied drug
information.
Currently, Sec. 201.56 (21 CFR 201.56) requires that prescription
drug labeling contain certain information in the format specified in
either Sec. 201.57 (21 CFR 201.57) or Sec. 201.80 (21 CFR 201.80),
depending on when the drug was approved for marketing. Section
201.56(a) sets forth general labeling requirements applicable to all
prescription drugs. Section 201.56(b) specifies the categories of new
and more recently approved prescription drugs subject to the revised
content and format requirements in Sec. Sec. 201.56(d) and 201.57.
Section 201.56(c) sets forth the schedule for implementing these
revised content and format requirements. Section 201.56(e) specifies
the sections and subsections, required and optional, for the labeling
of older prescription drugs not subject to the revised format and
content requirements.
Section 201.57(a) requires that prescription drug labeling for new
and more recently approved prescription drug products include a
``Highlights of Prescribing Information'' section. The ``Highlights''
section provides a concise extract of the most important information
required under Sec. 201.57(c) (the Full Prescribing Information
(FPI)), as well as certain additional information important to
prescribers. Section 201.57(b) requires a table of contents to
[[Page 58777]]
prescribing information entitled ``Full Prescribing Information:
Contents,'' consisting of a list of each heading and subheading along
with its identifying number to facilitate health care practitioners'
use of labeling information. Section 201.57(c) specifies the contents
of the FPI. Section 201.57(d) mandates the minimum specifications for
the format of prescription drug labeling and establishes minimum
requirements for key graphic elements such as bold type, bullet points,
type size, and spacing.
Older drugs not subject to the revised labeling content and format
requirements in Sec. 201.57 are subject to labeling requirements at
Sec. 201.80. Section 201.80(f)(2) requires that, within 1 year, any
FDA-approved patient labeling be referenced in the ``Precautions''
section of the labeling of older products and either accompany or be
reprinted immediately following the labeling.
Annual Burden for Prescription Drug Labeling Design, Testing, and
Submitting to FDA for New Drug Applications (NDAs) and Biologics
License Applications (BLAs) (Sec. Sec. 201.56 and 201.57)
New drug product applicants must: (1) Design and create
prescription drug labeling containing ``Highlights,'' ``Contents,'' and
FPI; (2) test the designed labeling (e.g., to ensure that the designed
labeling fits into carton-enclosed products); and (3) submit it to FDA
for approval. Based on the projected data used in the January 24, 2006,
final rule, FDA estimates that it will take applicants approximately
2,327 hours to design, test, and submit prescription drug labeling to
FDA as part of a NDA or a BLA under the revised regulations. Currently,
approximately 406 applicants submit approximately 541 new applications
(NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.
In the Federal Register of July 20, 2018 (83 FR 34596), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments. One comment
encouraged the use of ``provider-neutral language'' in specific
regulations. The second comment discussed the distribution of package
inserts for prescription drugs via paper labeling. Because these
comments do not apply to the regulations associated with the
information collection, we have not addressed them here.
Our estimate of the burden for the information collection is as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part and activity Number of responses per Total annual Average burden Total hours
respondents respondent \2\ responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec. Sec. 201.56 and 201.57............ 406 1.332 541 2,327 1,258,907
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Estimates may not sum due to rounding.
Our estimated burden for the information collection reflects an
overall increase of 602,503 hours and a corresponding increase of 345
records. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25352 Filed 11-20-18; 8:45 am]
BILLING CODE 4164-01-P
