[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Notices]
[Pages 16108-16110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1111]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Permanent Discontinuation or Interruption in 
Manufacturing of Certain Drug and Biological Products

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 ``Permanent Discontinuation or Interruption 
in Manufacturing of Certain Drug and Biological Products.''

DATES: Submit either electronic or written comments on the collection 
of information by June 12, 2018.

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 June 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 12, 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.

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-2018-N-1111 for ``Permanent Discontinuation or Interruption in 
Manufacturing of Certain Drug and Biological Products.'' 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 
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, 
[email protected].

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

[[Page 16109]]

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.

Permanent Discontinuation or Interruption in Manufacturing of Certain 
Drug and Biological Products--21 CFR 310.306, 314.81(b)(3)(iii), and 
600.82

OMB Control Number 0910-0759--Extension

    Sections 310.306, 314.81(b)(3)(iii), and 600.82 (21 CFR 310.306, 
314.81(b)(3)(iii), and 600.82) were modified to implement sections 506C 
and 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c 
and 356e) as amended by the Food and Drug Administration Safety and 
Innovation Act. Under these sections, applicants with an approved new 
drug application (NDA) or abbreviated new drug application (ANDA) for a 
covered drug product, manufacturers of a covered drug product marketed 
without an approved application, and applicants with an approved 
biologics license application (BLA) for a covered biological product 
(including certain applications of blood or blood components) must 
notify FDA in writing of a permanent discontinuance of the manufacture 
of the drug or biological product, or an interruption in manufacturing 
of the drug or biological product, that is likely to lead to a 
meaningful disruption in the applicant's supply (or a significant 
disruption for blood or blood components) of that product. The 
notification is required if the drug or biological product is life 
supporting, life sustaining, or intended for use in the prevention or 
treatment of a debilitating disease or condition, including use in 
emergency medical care or during surgery, and if the drug or biological 
product is not a radiopharmaceutical drug product.
    The regulations also require that the notification include the 
following information: (1) The name of the drug or biological product 
subject to the notification, including the National Drug Code Directory 
(NDC) (or, for a biological product that does not have an NDC, an 
alternative standard for identification and labeling that has been 
recognized as acceptable by the Center Director); (2) the name of each 
applicant of the drug or biological product; (3) whether the 
notification relates to a permanent discontinuance of the drug or 
biological product or an interruption in manufacturing of the product; 
(4) a description of the reason for the permanent discontinuance or 
interruption in manufacturing; and (5) the estimated duration of the 
interruption in manufacturing. The notification must be submitted to 
FDA electronically at least 6 months prior to the date of the permanent 
discontinuance or interruption in manufacturing. If 6 months' advance 
notice is not possible because the permanent discontinuance or 
interruption in manufacturing was unanticipated 6 months in advance, 
the applicant must notify FDA as soon as practicable, but in no case 
later than 5 business days after the permanent discontinuance or 
interruption in manufacturing occurs.
    If an applicant fails to submit the required notification, FDA will 
issue a letter informing the applicant or manufacturer of its 
noncompliance. The applicant must submit to FDA, not later than 30 
calendar days after FDA issues the letter, a written response setting 
forth the basis for noncompliance and providing the required 
notification.
    Description of Respondents: Applicants of prescription drugs and 
biological products subject to an approved NDA, ANDA, or BLA, and 
manufacturers of prescription drug products marketed without an 
approved ANDA or NDA, if the product is life supporting, life 
sustaining, or intended for use in the prevention or treatment of a 
debilitating disease or condition, including use in emergency medical 
care or during surgery, or is not a radiopharmaceutical product. If the 
BLA applicant is a manufacturer of blood or blood components, it is 
only subject to these regulations if it manufactures a significant 
percentage of the nation's blood supply.
    Burden Estimates: Based on the number of drug and biological 
product shortage related notifications we have seen in the past 12 
months, we estimate that annually a total of approximately 75 
respondents (``No. of Respondents'' in table 1) will notify us of a 
permanent discontinuance of the manufacture of a drug or biological 
product or an interruption in manufacturing of a drug or biological 
product that is likely to lead to a meaningful disruption in the 
respondent's supply of that product. We estimate that these respondents 
will submit annually a total of approximately 352.5 notifications as 
required under Sec. Sec.  310.306, 314.81(b)(3)(iii), and 600.82. We 
estimate 4.7 notifications per respondent, because a respondent may 
experience multiple discontinuances or interruptions in manufacturing 
in a year that require notification (``No. of Responses per 
Respondent'' in table 1). We also estimate that preparing and 
submitting these notifications to FDA will take approximately 2 hours 
per respondent (``Average Burden per Response'' in table 1).
    FDA estimates the burden of this collection of information as 
follows:

[[Page 16110]]



                                                         Table 1--Estimated Reporting Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Notifications required under Sec.  Sec.   310.306 (unapproved                    75              4.7            352.5                2              705
 drugs), 314.81(b)(3)(iii) (products approved under an NDA or
 ANDA), and 600.82 (products approved under a BLA).................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden for this information collection has changed 
since the previous OMB approval. The current burden is based on the 
number of actual new notifications received including notifications 
that were counted previously under the OMB approval for the interim 
final rule entitled ``Permanent Discontinuance or Interruption in 
Manufacturing of Certain Drug or Biological Products'' (80 FR 38915, 
July 8, 2015) (OMB control number 0910-0699).

    Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07684 Filed 4-12-18; 8:45 am]
 BILLING CODE 4164-01-P


