[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6036-6038]
[FR Doc No: 2018-02765]

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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.

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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:<PHONE_NUMBER>, 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,<PHONE_NUMBER>,
[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

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\
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                                                   Number of
  Type of submission (21 CFR       Number of      disclosures     Total annual    Average burden    Total hours
           section)               respondents   per respondent     disclosures    per disclosure
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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)).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                   Number of
  Type of submission (21 CFR       Number of     responses per    Total annual    Average burden    Total hours
           section)               respondents     respondent        responses      per response
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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
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\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.

    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