Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 30686-30688 [2015-12957]
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Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–13009 Filed 5–28–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a
forthcoming meeting of public advisory
committees of the Food and Drug
Administration (FDA). The meeting will
be open to the public.
Name of Committees: Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on July 7, 2015, from 8 a.m. to
5 p.m. and July 8, 2015, from 8 a.m. to
4:30 p.m.
ADDRESSES: Location: FDA White Oak
Campus, 10903 New Hampshire Ave.,
Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring,
MD 20993–0002. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Contact Person: Stephanie L. Begansky,
Lhorne on DSK2VPTVN1PROD with NOTICES
SUMMARY:
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Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, AADPAC@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committees will discuss
the results of post-marketing studies
evaluating the misuse and/or abuse of
reformulated OXYCONTIN (oxycodone
hydrochloride) extended-release tablets,
supplemental new drug application
(sNDA) 022272, manufactured by
Purdue Pharma L.P. The committees
will discuss whether these studies have
demonstrated that the reformulated
OXYCONTIN product has had a
meaningful impact on abuse of
OXYCONTIN.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 22, 2015. Oral
presentations from the public will be
scheduled between approximately 8:30
a.m. and 10:30 a.m. on July 8, 2015.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
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proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before June 12, 2015. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 15, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Stephanie L.
Begansky at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–13004 Filed 5–28–15; 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; 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
SUMMARY:
E:\FR\FM\29MYN1.SGM
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Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
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 June 29,
2015.
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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
format and content of labeling for
human prescription drug and biological
products were revised in the Federal
Register of January 24, 2006 (71 FR
3922), 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 due to
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 ‘‘Highlights of
Prescribing Information.’’ ‘‘Highlights’’
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 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.
In the Federal Register of January 21,
2015 (80 FR 2943), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received two
comments, however, these comments
did not address the information
collection.
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
takes applicants approximately 3,349
hours to design, test, and submit
prescription drug labeling to FDA as
part of an NDA or a BLA under the
revised regulations. Currently,
approximately 131 applicants submit
approximately 196 new applications
(NDAs and BLAs) to FDA annually,
totaling 656,404 hours.
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
Labeling Requirements in §§ 201.56 and 201.57 ................
131
1.5
196
3,349
656,404
Lhorne on DSK2VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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30688
Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
Dated: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12957 Filed 5–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0902]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Product Labeling; Medication Guide
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506 (c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collections of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information listed below.
With respect to the following
collection of information, FDA invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumption used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
FOR FURTHER INFORMATION CONTACT:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
regulations requiring the distribution of
patient labeling, called Medication
Guides, for certain products that pose a
serious and significant public health
concern requiring distribution of FDAapproved patient medication.
DATES: Submit either electronic or
written comments on the collection of
information by July 28, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
SUMMARY:
Prescription Drug Product Labeling;
Medication Guide Requirements
OMB Control Number 0910–0393—
Extension
FDA regulations require the
distribution of patient labeling, called
Medication Guides, for certain
prescription human drug and biological
products used primarily on an
outpatient basis that pose a serious and
significant public health concern
requiring distribution of FDA-approved
patient medication information. These
Medication Guides inform patients
about the most important information
they should know about these products
in order to use them safely and
effectively. Included is information such
as the drug’s approved uses,
contraindications, adverse drug
reactions, and cautions for specific
populations, with a focus on why the
particular product requires a Medication
Guide. These regulations are intended to
improve the public health by providing
information necessary for patients to use
certain medication safely and
effectively.
The regulations contain the following
reporting requirements that are subject
to the PRA:
• 21 CFR 208.20—Applicants must
submit draft Medication Guides for FDA
approval according to the prescribed
content and format.
• 21 CFR 314.70(b)(3)(ii) and 21 CFR
601.12(f)—Application holders must
submit changes to Medication Guides to
FDA for prior approval as supplements
to their applications.
• 21 CFR 208.24(c)—Each distributor
or packer that receives Medication
Guides, or the means to produce
Medication Guides, from a manufacturer
under paragraph (b) of this section shall
provide those Medication Guides to
each authorized dispenser to whom it
ships a container of drug product.
• 21 CFR 208.24(e)—Each authorized
dispenser of a prescription drug product
for which a Medication Guide is
required, when dispensing the product
to a patient or to a patient’s agent, must
provide a Medication Guide directly to
each patient unless an exemption
applies under 21 CFR 208.26.
• 21 CFR 208.26(a)—Requests may be
submitted for exemption or deferral
from particular Medication Guide
content or format requirements.
Lhorne on DSK2VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Content and Format of a Medication Guide—208.20 .........
Supplements and Other Changes to an Approved Application—314.70 (b)(3)(ii), 601.12(f) .......................................
Exemptions and Deferrals—208.26(a) ................................
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Frm 00038
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
57
1
57
320
18,240
108
1
1
1
108
1
72
4
7,776
4
Fmt 4703
Sfmt 4703
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29MYN1
]]>Agencies
[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30686-30688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12957]
-----------------------------------------------------------------------
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; 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
[[Page 30687]]
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 June
29, 2015.
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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 format and content of labeling for
human prescription drug and biological products were revised in the
Federal Register of January 24, 2006 (71 FR 3922), 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 due to
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
``Highlights of Prescribing Information.'' ``Highlights'' 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 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.
In the Federal Register of January 21, 2015 (80 FR 2943), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments, however, these
comments did not address the information collection.
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 takes applicants approximately 3,349
hours to design, test, and submit prescription drug labeling to FDA as
part of an NDA or a BLA under the revised regulations. Currently,
approximately 131 applicants submit approximately 196 new applications
(NDAs and BLAs) to FDA annually, totaling 656,404 hours.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec. Sec. 201.56 and 201.57............ 131 1.5 196 3,349 656,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 30688]]
Dated: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12957 Filed 5-28-15; 8:45 am]
BILLING CODE 4164-01-P
