
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45619-45621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 reporting requirements 
contained in FDA's regulations on postmarketing reporting of 
information pertaining to drug shortages.

DATES: Submit either electronic or written comments on the collection 
of information by October 1, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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 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 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/reinstatement] 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,

[[Page 45620]]

when appropriate, and other forms of information technology.

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

    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. The 
provisions of the Federal Food, Drug and Cosmetic 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 of FDA's regulations 
implement section 506C of the Federal Food, Drug and Cosmetic Act. 
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) of the Federal Food, Drug, and Cosmetic 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, 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 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 division or the CBER 
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(d)(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 Federal Food, Drug, and Cosmetic Act; and (3) was not 
originally derived from human tissue and replaced by a recombinant 
product.

[[Page 45621]]

    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 
Federal Food, Drug, and Cosmetic 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 as a result of the interim final rule. 
Adjusting to include an additional two 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, 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 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 5 
manufacturers will request a certification of good cause each year. 
Therefore, the number of respondents is estimated to be 5. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual 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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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: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18771 Filed 7-31-12; 8:45 am]
BILLING CODE 4160-01-P


