[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72353-72355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29327]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0813]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Applications for Food 
and Drug Administration Approval To Market a New Drug; Revision of 
Postmarketing Reporting Requirements--Discontinuance

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 January 
4, 2013.

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 0910-0699. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [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.

Applications for Food and Drug Administration Approval To Market a New 
Drug; Revision of Postmarketing Reporting Requirements--
Discontinuance--(OMB Control Number 0910-0699)--Reinstatement

    FDA published an interim final rule on December 19, 2011 (76 FR 
78530), amending its postmarketing reporting regulations implementing 
certain provisions of the Federal Food, Drug and Cosmetic Act (FD&C 
Act). The provisions of the FD&C Act require manufacturers who are the 
sole manufacturers of certain drug products to notify FDA at least 6 
months before discontinuance of manufacture of the products. The 
interim final rule modified the term ``discontinuance'' and clarified 
the term ``sole manufacturer'' with respect to notification of 
discontinuance requirements. The broader reporting resulting from these 
changes will enable FDA to improve its collection and distribution of 
drug shortage information to physician and patient organizations and to 
work with manufacturers and other stakeholders to respond to potential 
drug shortages.
    Sections 314.81(b)(3)(iii) and 314.91 (21 CFR 314.81(b)(3)(iii) and 
314.91) of FDA's regulations implement section 506C of the FD&C Act (21 
U.S.C. 355c). Section 314.81(b)(3)(iii) requires entities who are the 
sole manufacturers of certain drug products to notify us at least 6 
months before discontinuance of manufacture of the product. For the 
regulations to apply, a product must meet the following three criteria:
    1. The product must be life supporting, life sustaining, or 
intended for use in the prevention of a debilitating disease or 
condition;
    2. The product must have been approved by FDA under section 505(b) 
or 505(j) (21 U.S.C. 355(b) or 355(j)) of the FD&C Act; and
    3. The product must not have been originally derived from human 
tissue and replaced by a recombinant product.
    Under Sec.  314.81(b)(3)(iii)(c), FDA will publicly disclose 
information about drug products subject to section 506C that are to be 
discontinued. Section 314.91 allows us to reduce the 6-month 
notification period if we find that good cause exists for the 
reduction. A manufacturer may request that we reduce the notification 
period by certifying that good cause for the reduction exists.
    FDA added Sec. Sec.  314.81(b)(3)(iii) and 314.91 to its 
regulations in the Federal Register of October 18, 2007 (72 FR 58993). 
Sections 314.81(b)(3)(iii) and 314.91 require two new reporting 
requirements to FDA that are subject to OMB approval under the PRA: 
Notification of Discontinuance and Certification of Good Cause. The 
December 19, 2011, interim final rule added two new definitions to 
Sec.  314.81(b)(3)(iii): ``Discontinuance'' and ``sole manufacturer.'' 
The interim final rule clarified the scope of manufacturers required to 
report and expanded the range of circumstances required to be reported 
to the Agency under Sec.  314.81(b)(3)(iii), but did not change the 
substantive content of the reports required to be submitted to the 
Agency. This PRA analysis covers the information collection resulting 
from the October 18, 2007, final rule and also includes estimates of 
how the number of Notifications of Discontinuance and Certifications of 
Good Cause may increase as a result of the interim final rule.

A. Notification of Discontinuance

    Under Sec.  314.81(b)(3)(iii), at least 6 months before a sole 
manufacturer intends to discontinue manufacture of a drug product 
subject to section 506C of the FD&C Act, the manufacturer must send us 
notification of the discontinuance. The notification of discontinuance 
generally contains the name of the manufacturer, the name of the 
product to be discontinued, the reason for the discontinuance, and the 
date of discontinuance. FDA will work with relevant manufacturers 
during the 6-month notification period to help minimize the effect of 
the discontinuance on patients and health care providers, and to 
distribute appropriate information about the discontinuance to 
physician and patient organizations. The interim final rule added 
definitions of ``discontinuance'' and ``sole manufacturer'' to Sec.  
314.81(b)(3)(iii). The inclusion of these definitions expands 
notification requirements under Sec.  314.81(b)(3)(iii) to additional 
discontinuance circumstances and clarifies the scope of manufacturers 
who must report discontinuances. The interim final rule also required 
that notifications of discontinuance be submitted either electronically 
or by telephone according to instructions on FDA's Drug Shortage Web 
site at http://www.fda.gov/Drugs/DrugSafety/DrugShortages. This change 
ensures that the appropriate offices are timely notified of all 
relevant discontinuances. It also reflects existing practice for 
submitting notices of discontinuance, and reduces the burden on 
industry to submit multiple copies of the notification.

B. Certification of Good Cause

    FDA may reduce the 6-month notification period if we find good 
cause for the reduction. As described in Sec.  314.91, a manufacturer 
can request a reduction in the notification period by submitting 
written certification that good cause exists to the following 
designated offices: (1) The Center for Drug Evaluation and Research 
(CDER) Drug Shortage Coordinator at the address of the Director of 
CDER; (2) the CDER Drug Registration and Listing Team, Division of 
Compliance Risk Management and Surveillance in CDER; and (3) the 
director of either the CDER

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division or the Center for Biologics Evaluation and Research office 
that is responsible for reviewing the application. The following 
circumstances may establish good cause:
     A public health problem may result from continuation of 
manufacturing for the 6-month period (Sec.  314.91(d)(1));
     A biomaterials shortage prevents the continuation of 
manufacturing for the 6-month period (Sec.  314.91(d)(2));
     A liability problem may exist for the manufacturer if the 
manufacturing is continued for the 6-month period (Sec.  314.91(d)(3));
     Continuation of the manufacturing for the 6-month period 
may cause substantial economic hardship for the manufacturer (Sec.  
314.91(d)(4));
     The manufacturer has filed for bankruptcy under chapter 7 
or 11 of title 11, United States Code (Sec.  314.91(d)(5));
     The manufacturer can stop making the product but still 
distribute it to satisfy existing market need for 6 months (Sec.  
314.91(d)(6)); or
     Other good cause exists for a reduction in the 
notification period (Sec.  314.91(d7) (7)).
    With each certification described previously, the manufacturer must 
describe in detail the basis for its conclusion that such circumstances 
exist. We require that the written certification that good cause exists 
be submitted to the offices identified previously to ensure that our 
efforts to address the discontinuance take place in a timely manner. 
The interim final rule made no changes to the requirements or process 
for certification of good cause.
    Description of Respondents: An applicant that is the sole 
manufacturer and who is discontinuing manufacture of a drug product 
that meets the following criteria: (1) Is life supporting, life 
sustaining, or intended for use in the prevention of a debilitating 
disease or condition; (2) was approved by FDA under section 505(b) or 
(j) of the FD&C Act; and (3) was not originally derived from human 
tissue and replaced by a recombinant product.
    Burden Estimate: The table below provides an estimate of the annual 
reporting burden for notification of a product discontinuance and 
certification of good cause under Sec. Sec.  314.81(b)(3)(iii) and 
314.91, as amended by the interim final rule.
    Notification of Discontinuance: Based on data collected from the 
CDER Drug Shortage Coordinator since December 17, 2007, when Sec. Sec.  
314.81(b)(3)(iii) and 314.91 went into effect, one manufacturer during 
each year reported to FDA a discontinuance of one drug product meeting 
the criteria of section 506C and its implementing regulations (i.e., 
the drug product was approved under section 505(b) or (j) of the FD&C 
Act, the drug product was ``life-supporting, life-sustaining or 
intended for use in the prevention of a debilitating disease or 
condition,'' the drug product was produced by a sole manufacturer, and 
the drug product was permanently discontinued). CDER's Drug Shortages 
Coordinator tracked 220 drug shortages between January and October of 
2011. The Agency estimates that 30 percent (66) of these shortages 
would relate to discontinuances subject to mandatory reporting under 
section 506C of the FD&C Act as a result of the interim final rule. 
Adjusting to include an additional 2 months of reporting (November and 
December), we estimate that FDA will receive a total of 80 
notifications of a discontinuance per year under section 506C of the 
FD&C Act, as amended by the interim final rule. Based on experience, a 
manufacturer submits only one notification of a discontinuance per 
year, thus the total number of manufacturers who would be required to 
notify us of a discontinuance would be 80. Therefore, the number of 
respondents is estimated to be 80. The hours per response is the 
estimated number of hours that a respondent would spend preparing the 
information to be submitted with a notification of product 
discontinuance, including the time it takes to gather and copy the 
statement. Based on experience in working with manufacturers to submit 
notifications under Sec.  314.81(b)(3)(iii), we estimate that 
approximately 2 hours on average are needed per response. We do not 
expect the changes in the interim final rule to affect the number of 
hours per response. Therefore, we estimate that respondents will spend 
160 hours per year notifying us of a product discontinuance under these 
regulations.
    Certification of Good Cause: Based on data collected from the CDER 
drug shortage coordinator since 2007, one manufacturer each year 
reported a discontinuance of one drug product under section 506C of the 
FD&C Act and its implementing regulations. Each manufacturer has the 
opportunity under Sec.  314.91 to request a reduction in the 6-month 
notification period by certifying to us that good cause exists for the 
reduction. The Agency has received no certifications of good cause 
since 2007. Although we expect we will receive an increase in the 
number of reports of discontinuances as a result of the changes in the 
interim final rule, because of the limited circumstances under which 
good cause can be requested or would be appropriately granted, we do 
not expect a correspondingly large increase in the number of 
manufacturers requesting a certification of good cause. We estimate 
that only five manufacturers will request a certification of good cause 
each year. Therefore, the number of respondents is estimated to be 
five. The total annual responses are the total number of certifications 
of good cause that are expected to be submitted to us in a year. We 
estimate that the total annual responses will remain small, averaging 
one response per respondent. The hours per response is the estimated 
number of hours that a respondent spends preparing the detailed 
information certifying that good cause exists for a reduction in the 
notification period, including the time it takes to gather and copy the 
documents. We estimate that approximately 16 hours on average are 
needed per response. Therefore, we estimate that 80 hours will be spent 
per year by respondents certifying that good cause exists for a 
reduction in the 6-month notification period under Sec.  314.91.
    In the Federal Register of August 1, 2012 (77 FR 45619), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Notification of Discontinuance                80               1              80               2             160
 (314.81(b)(3)(iii).............
Certification of Good Cause                    5               1               5              16              80
 (314.91).......................
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    Total.......................  ..............  ..............  ..............  ..............             240
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: November 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29327 Filed 12-4-12; 8:45 am]
BILLING CODE 4160-01-P