[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]


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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: 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\
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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
----------------------------------------------------------------------------------------------------------------
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.


[[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


