
[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Notices]
[Pages 46248-46250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5624]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 the content and format requirements for 
pregnancy and lactation labeling for human prescription drugs and 
biological products.

DATES: Submit either electronic or written comments on the collection 
of information by December 4, 2017.

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 December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 4, 2017. 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.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the 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-2017-N-5624 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Content and Format of Labeling 
for Human Prescription Drugs and Biological Products; Requirements for 
Pregnancy and Lactation Labeling.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those

[[Page 46249]]

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 
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 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/2015-23389.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:  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.

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 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 collection 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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 assumptions 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.

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 
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), 601.2 (21 CFR 601.2), 
and 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 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) (21 CFR 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).
    As indicated in Tables 1 and 2 of this document, we estimate that 
the burden associated with the information collection to be 1,598,000 
hours.

[[Page 46250]]

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of                           Average
  Type of submission (21 CFR      Number of     responses per     Total annual      burden per     Total  hours
           section)              respondents      respondent        responses        response
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Supplements to applications               390               26  10,140                       120       1,216,800
 approved 6/30/01 to 6/30/15                                     (Submitted 3rd,
 (Sec.  Sec.   314.70(b),                                        4th, and 5th
 601.12(f)(1)).                                                  years after 6/
                                                                 30/15).
Annual report submission of               320              ~17  5,500 (Submitted              40         220,000
 revised labeling for                                            3rd year after
 applications that contain a                                     6/30/15).
 pregnancy category, approved
 before 6/30/01 (Sec.  Sec.
 314.70(d), 601.12(f)(3)).
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ...............  ................  ..............       1,436,800
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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 Third-Party Disclosure Burden \1\
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                                                  Number of                           Average
 Type of submission  (21 CFR      Number of      disclosures      Total annual      burden per     Total  hours
           section)              respondents    per respondent     disclosures      disclosure
----------------------------------------------------------------------------------------------------------------
New Drug Applications (NDAs)/             390              ~10  4,000 (Submitted              40         160,000
 Abbreviated New Drug                                            during 10-year
 Applications (ANDAs)/                                           period after 6/
 Biologics License                                               30/15).
 Applications (BLAs)/efficacy
 supplements submitted on or
 after 6/30/15, including
 amendments to applications
 pending as of 6/30/15 (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.

    FDA estimates that approximately 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 applications. This estimate also includes labeling 
amendments submitted to FDA for applications pending as of the 
effective date of the final rule. FDA estimates that it will take 
applicants approximately 40 hours to prepare and submit the subject 
labeling. This estimate applies only to the requirements of the final 
rule 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 3rd, 4th, and 5th 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 NDAs, BLAs, and efficacy supplements; 1,320 ANDA 
supplements; and 7,750 drug product labeling supplements from 
repackagers and relabelers. FDA estimates that approximately 390 
application holders, repackagers, and relabelers will submit these 
supplements, and that it will take approximately 120 hours to prepare 
and submit each supplement.
    FDA also estimates that application holders will submit 
approximately 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.

    Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21292 Filed 10-3-17; 8:45 am]
BILLING CODE 4164-01-P


