Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling, 6036-6038 [2018-02765]
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Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
was initially submitted on August 30,
2012.
3. The date the application was
approved: August 13, 2014. FDA has
verified the applicant’s claim that NDA
204569 was approved on August 13,
2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks zero days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02763 Filed 2–9–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5624]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Content and
Format of Labeling for Human
Prescription Drugs and Biological
Products; Requirements for Pregnancy
and Lactation Labeling
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 March 14,
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 0910–0624. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
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:
Content and Format of Labeling for
Human Prescription Drugs and
Biological Products; Requirements for
Pregnancy and Lactation Labeling
OMB Control Number 0910–0624—
Extension
This information collection supports
Agency regulations regarding the
content and format requirements for
pregnancy and lactation labeling. In the
Federal Register of December 4, 2014
(79 FR 72064), FDA published a final
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Sfmt 4703
rule entitled ‘‘Content and Format of
Labeling for Human Prescription Drug
and Biological Products; Requirements
for Pregnancy and Lactation Labeling.’’
The final rule amended FDA regulations
concerning the content and format of
the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’
and ‘‘Nursing mothers’’ subsections of
the ‘‘Use in Specific Populations’’
section of the labeling for human
prescription drugs. The regulations now
require, among other things, a summary
of the risks of using a drug during
pregnancy and lactation and a
discussion of the data supporting that
summary. The labeling must also
include relevant information to help
health care providers make prescribing
decisions and counsel women about the
use of drugs during pregnancy and
lactation. The final rule eliminated the
pregnancy categories A, B, C, D, and X.
In addition, FDA eliminated the ‘‘Labor
and delivery’’ subsection because the
‘‘Pregnancy’’ subsection includes
information on labor and delivery. The
final rule also required that the labeling
include relevant information about
pregnancy testing, contraception, and
infertility for health care providers
prescribing for females and males of
reproductive potential. In addition, the
final rule provided for a 10-year
implementation schedule for
compliance with the relevant
regulations. As the implementation
schedule is realized, FDA plans to
discontinue this separate information
collection and incorporate the
provisions into existing collections as
appropriate.
The content and format requirements
apply to:
• Applications submitted on or after
June 30, 2015 (§§ 314.50 (21 CFR
314.50), 314.70(b) (21 CFR 314.70(b)),
601.2 (21 CFR 601.2), and 601.12(f)(1))
(21 CFR 601.12(f)(1));
• amendments to applications
pending on June 30, 2015 (§§ 314.60 (21
CFR 314.60), 601.2, and 601.12(f)(1));
• supplements to applications
approved from June 30, 2001, to June
30, 2015 (§§ 314.70(b) and 601.12(f)(1));
and
• annual reports for applications
approved before June 30, 2001, that
contain a pregnancy category, to report
removal of the pregnancy category letter
in their labeling (§§ 314.70(d) and
601.12(f)(3)).
Under § 201.57(c)(9)(i) and (ii) (21
CFR 201.57(c)(9)(i) and (ii)), holders of
approved applications must provide
new labeling content in a new format—
that is, to rewrite the pregnancy and
lactation portions of each drug’s
labeling. Section 201.57(c)(9)(iii)
requires that labeling must include the
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Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
new subsection 8.3, ‘‘Females and males
of reproductive potential.’’ Application
holders are required to submit prior
approval supplements to their approved
applications before distribution of the
new labeling, as required in § 314.70(b)
or § 601.12(f)(1) (21 CFR 601.12(f)(1)).
Under 21 CFR 201.80(f)(6)(i), holders
of approved applications are required to
remove the pregnancy category
designation (e.g., ‘‘Pregnancy Category
C’’) from the ‘‘Pregnancy’’ subsection of
the ‘‘Precautions’’ section of the
labeling. These application holders
must report the labeling change in their
annual reports, as required in
§ 314.70(d) or § 601.12(f)(3).
In the Federal Register of October 4,
2017 (82 FR 46248), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. Two
comments were received in response to
the notice, however both comments
discussed specific requirements found
in FDA regulations rather than the four
information collection topics solicited
in our notice under the PRA. We have
therefore not made adjustments to our
burden estimate for the information
collection, which is as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of submission
(21 CFR section)
Number of
respondents
New NDAs/ANDAs/BLAs/efficacy supplements
submitted on or after June 30, 2015, including
amendments to applications pending as of
June 30, 2015 (§§ 314.50, 314.60, 314.70(b),
601.2, 601.12(f)(1)).
1 There
Number of
disclosures
per
respondent
∼10
390
Total annual disclosures
4,000 (Submitted during
10-year period after
June 30, 2015).
Average
burden per
disclosure
40
Total hours
160,000
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of submission
(21 CFR section)
Number of
respondents
Number of
responses per
respondent
Supplements to applications approved June 30,
2001 to June 30, 2015 (§§ 314.70(b),
601.12(f)(1)).
Annual report submission of revised labeling for
applications that contain a pregnancy category, approved before June 30, 2001
(§§ 314.70(d), 601.12(f)(3)).
390
26
320
∼17
Total ...............................................................
........................
........................
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1 There
Total annual responses
10,150 (Submitted 3rd,
4th, and 5th years
after June 30, 2015).
5,500 (Submitted 3rd
year after June 30,
2015).
.......................................
Average
burden per
response
Total hours
120
1,218,000
40
220,000
........................
1,438,000
are no capital costs or operating and maintenance costs associated with this collection of information.
As indicated in tables 1 and 2, we
estimate the burden associated with the
information collection to be 1,598,000
hours. We estimate 4,000 applications
containing the subject labeling will be
submitted by approximately 390
applicants and repackagers and
relabelers to FDA over the 10-year
period beginning June 30, 2015. This
figure (4,000 applications) includes
labeling for approximately 800
applications submitted under section
505(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
505(b)) or section 351 of the Public
Health Service Act (42 U.S.C. 262),
1,200 applications submitted under
section 505(j) of the FD&C Act, and
2,000 revised drug product labeling
from repackagers and relabelers for
approximately 2,000. This estimate also
includes labeling amendments
submitted to FDA for applications
pending as of the effective date of the
final rule. We estimate it will take
applicants 40 hours to prepare and
submit the subject labeling. This
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estimate applies only to the
requirements found in the previous
paragraphs and does not indicate the
total hours required to prepare and
submit complete labeling for these
applications. The information collection
burden to prepare and submit labeling
in accordance with §§ 201.56 (21 CFR
201.56), 201.57, and 201.80 is approved
by OMB under control numbers 0910–
0572 and 0910–0001.
In addition, during the third, fourth,
and fifth years after the effective date of
the final rule, the Agency estimates that
it will receive approximately 10,150
supplements to applications that were
either approved from June 30, 2001, to
the effective date or were pending as of
the effective date. This estimate
includes supplements for approximately
1,080 new drug application (NDAs), and
biologics license applications (BLAs),
and efficacy supplements; 1,320
abbreviated new drug application
(ANDA) supplements; and 7,750 drug
product labeling supplements from
repackagers and relabelers. FDA
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estimates 390 application holders,
repackagers, and relabelers will submit
these supplements, and that it will take
120 hours to prepare and submit each
supplement.
Finally, we estimate that application
holders will submit 5,500 annual
reports to FDA during the third year
after the effective date for applications
that contain a pregnancy category,
approved before June 30, 2001. This
estimate includes approximately 1,340
NDAs and BLAs and approximately
4,160 ANDAs containing labeling
changes as a result of the final rule. FDA
estimates that approximately 320
application holders will submit these
annual reports, and that it will take
approximately 40 hours for each
submission. The burden for this
information collection has not increased
since the last collection.
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6038
Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02765 Filed 2–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–3877]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AKYNZEO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for AKYNZEO and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 13, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 13, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 13,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 13, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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19:23 Feb 09, 2018
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instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–E–3877 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; AKYNZEO.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
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its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
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]]>Agencies
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6036-6038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02765]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5624]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Content and Format of
Labeling for Human Prescription Drugs and Biological Products;
Requirements for Pregnancy and Lactation Labeling
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 March
14, 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 0910-0624.
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.
Content and Format of Labeling for Human Prescription Drugs and
Biological Products; Requirements for Pregnancy and Lactation Labeling
OMB Control Number 0910-0624--Extension
This information collection supports Agency regulations regarding
the content and format requirements for pregnancy and lactation
labeling. In the Federal Register of December 4, 2014 (79 FR 72064),
FDA published a final rule entitled ``Content and Format of Labeling
for Human Prescription Drug and Biological Products; Requirements for
Pregnancy and Lactation Labeling.'' The final rule amended FDA
regulations concerning the content and format of the ``Pregnancy,''
``Labor and delivery,'' and ``Nursing mothers'' subsections of the
``Use in Specific Populations'' section of the labeling for human
prescription drugs. The regulations now require, among other things, a
summary of the risks of using a drug during pregnancy and lactation and
a discussion of the data supporting that summary. The labeling must
also include relevant information to help health care providers make
prescribing decisions and counsel women about the use of drugs during
pregnancy and lactation. The final rule eliminated the pregnancy
categories A, B, C, D, and X. In addition, FDA eliminated the ``Labor
and delivery'' subsection because the ``Pregnancy'' subsection includes
information on labor and delivery. The final rule also required that
the labeling include relevant information about pregnancy testing,
contraception, and infertility for health care providers prescribing
for females and males of reproductive potential. In addition, the final
rule provided for a 10-year implementation schedule for compliance with
the relevant regulations. As the implementation schedule is realized,
FDA plans to discontinue this separate information collection and
incorporate the provisions into existing collections as appropriate.
The content and format requirements apply to:
Applications submitted on or after June 30, 2015
(Sec. Sec. 314.50 (21 CFR 314.50), 314.70(b) (21 CFR 314.70(b)), 601.2
(21 CFR 601.2), and 601.12(f)(1)) (21 CFR 601.12(f)(1));
amendments to applications pending on June 30, 2015
(Sec. Sec. 314.60 (21 CFR 314.60), 601.2, and 601.12(f)(1));
supplements to applications approved from June 30, 2001,
to June 30, 2015 (Sec. Sec. 314.70(b) and 601.12(f)(1)); and
annual reports for applications approved before June 30,
2001, that contain a pregnancy category, to report removal of the
pregnancy category letter in their labeling (Sec. Sec. 314.70(d) and
601.12(f)(3)).
Under Sec. 201.57(c)(9)(i) and (ii) (21 CFR 201.57(c)(9)(i) and
(ii)), holders of approved applications must provide new labeling
content in a new format--that is, to rewrite the pregnancy and
lactation portions of each drug's labeling. Section 201.57(c)(9)(iii)
requires that labeling must include the
[[Page 6037]]
new subsection 8.3, ``Females and males of reproductive potential.''
Application holders are required to submit prior approval supplements
to their approved applications before distribution of the new labeling,
as required in Sec. 314.70(b) or Sec. 601.12(f)(1) (21 CFR
601.12(f)(1)).
Under 21 CFR 201.80(f)(6)(i), holders of approved applications are
required to remove the pregnancy category designation (e.g.,
``Pregnancy Category C'') from the ``Pregnancy'' subsection of the
``Precautions'' section of the labeling. These application holders must
report the labeling change in their annual reports, as required in
Sec. 314.70(d) or Sec. 601.12(f)(3).
In the Federal Register of October 4, 2017 (82 FR 46248), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. Two comments were received
in response to the notice, however both comments discussed specific
requirements found in FDA regulations rather than the four information
collection topics solicited in our notice under the PRA. We have
therefore not made adjustments to our burden estimate for the
information collection, which is as follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of submission (21 CFR Number of disclosures Total annual Average burden Total hours
section) respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
New NDAs/ANDAs/BLAs/efficacy 390 ~10 4,000 (Submitted 40 160,000
supplements submitted on or during 10-year
after June 30, 2015, period after
including amendments to June 30, 2015).
applications pending as of
June 30, 2015 (Sec. Sec.
314.50, 314.60, 314.70(b),
601.2, 601.12(f)(1)).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of submission (21 CFR Number of responses per Total annual Average burden Total hours
section) respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Supplements to applications 390 26 10,150 120 1,218,000
approved June 30, 2001 to (Submitted 3rd,
June 30, 2015 (Sec. Sec. 4th, and 5th
314.70(b), 601.12(f)(1)). years after
June 30, 2015).
Annual report submission of 320 ~17 5,500 (Submitted 40 220,000
revised labeling for 3rd year after
applications that contain a June 30, 2015).
pregnancy category, approved
before June 30, 2001 (Sec.
Sec. 314.70(d),
601.12(f)(3)).
-------------------------------- -------------------------------
Total..................... .............. .............. ................ .............. 1,438,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
As indicated in tables 1 and 2, we estimate the burden associated
with the information collection to be 1,598,000 hours. We estimate
4,000 applications containing the subject labeling will be submitted by
approximately 390 applicants and repackagers and relabelers to FDA over
the 10-year period beginning June 30, 2015. This figure (4,000
applications) includes labeling for approximately 800 applications
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 505(b)) or section 351 of the Public Health
Service Act (42 U.S.C. 262), 1,200 applications submitted under section
505(j) of the FD&C Act, and 2,000 revised drug product labeling from
repackagers and relabelers for approximately 2,000. This estimate also
includes labeling amendments submitted to FDA for applications pending
as of the effective date of the final rule. We estimate it will take
applicants 40 hours to prepare and submit the subject labeling. This
estimate applies only to the requirements found in the previous
paragraphs and does not indicate the total hours required to prepare
and submit complete labeling for these applications. The information
collection burden to prepare and submit labeling in accordance with
Sec. Sec. 201.56 (21 CFR 201.56), 201.57, and 201.80 is approved by
OMB under control numbers 0910-0572 and 0910-0001.
In addition, during the third, fourth, and fifth years after the
effective date of the final rule, the Agency estimates that it will
receive approximately 10,150 supplements to applications that were
either approved from June 30, 2001, to the effective date or were
pending as of the effective date. This estimate includes supplements
for approximately 1,080 new drug application (NDAs), and biologics
license applications (BLAs), and efficacy supplements; 1,320
abbreviated new drug application (ANDA) supplements; and 7,750 drug
product labeling supplements from repackagers and relabelers. FDA
estimates 390 application holders, repackagers, and relabelers will
submit these supplements, and that it will take 120 hours to prepare
and submit each supplement.
Finally, we estimate that application holders will submit 5,500
annual reports to FDA during the third year after the effective date
for applications that contain a pregnancy category, approved before
June 30, 2001. This estimate includes approximately 1,340 NDAs and BLAs
and approximately 4,160 ANDAs containing labeling changes as a result
of the final rule. FDA estimates that approximately 320 application
holders will submit these annual reports, and that it will take
approximately 40 hours for each submission. The burden for this
information collection has not increased since the last collection.
[[Page 6038]]
Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02765 Filed 2-9-18; 8:45 am]
BILLING CODE 4164-01-P
