[Federal Register Volume 83, Number 144 (Thursday, July 26, 2018)]
[Notices]
[Pages 35488-35490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15948]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1011]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Permanent 
Discontinuation or Interruption in Manufacturing of Certain Drug and 
Biological Products

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 August 
27, 2018.

[[Page 35489]]


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 0910-0759. 
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.

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 requires 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).
    In the Federal Register of April 13, 2018, (83 FR 16108), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                                         Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 35490]]

    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: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15948 Filed 7-25-18; 8:45 am]
 BILLING CODE 4164-01-P