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, 72353-72355 [2012-29327]
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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
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.
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
oira_submission@omb.eop.gov. 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.
SUMMARY:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
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.
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with
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
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Jkt 229001
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 § 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 §§ 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
§ 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 § 314.81(b)(3)(iii), but did not
change the substantive content of the
reports required to be submitted to the
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Fmt 4703
Sfmt 4703
72353
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 § 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
§ 314.81(b)(3)(iii). The inclusion of these
definitions expands notification
requirements under § 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 https://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
§ 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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05DEN1
72354
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
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 (§ 314.91(d)(1));
• A biomaterials shortage prevents
the continuation of manufacturing for
the 6-month period (§ 314.91(d)(2));
• A liability problem may exist for
the manufacturer if the manufacturing is
continued for the 6-month period
(§ 314.91(d)(3));
• Continuation of the manufacturing
for the 6-month period may cause
substantial economic hardship for the
manufacturer (§ 314.91(d)(4));
• The manufacturer has filed for
bankruptcy under chapter 7 or 11 of title
11, United States Code (§ 314.91(d)(5));
• The manufacturer can stop making
the product but still distribute it to
satisfy existing market need for 6
months (§ 314.91(d)(6)); or
• Other good cause exists for a
reduction in the notification period
(§ 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
§§ 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 §§ 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 ‘‘lifesupporting, 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 § 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
§ 314.91 to request a reduction in the 6month 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 § 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 BURDEN1
Number of
respondents
mstockstill on DSK4VPTVN1PROD with
21 CFR Section
Notification of Discontinuance (314.81(b)(3)(iii) ..................
Certification of Good Cause (314.91) ..................................
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Number of
responses per
respondent
80
5
Fmt 4703
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Total annual
responses
1
1
E:\FR\FM\05DEN1.SGM
80
5
05DEN1
Average
burden per
response
2
16
Total hours
160
80
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
72355
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Number of
respondents
21 CFR Section
Total ..............................................................................
1There
[FR Doc. 2012–29327 Filed 12–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2012–N–0273]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Review; Experimental Study
of Graphic Cigarette Warning Labels
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a reinstatement 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
(the PRA).
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0668. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
240
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.
ACTION:
Number of
responses per
respondent
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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.
VerDate Mar<15>2010
17:19 Dec 04, 2012
Jkt 229001
The Tobacco Control Act (Pub. L.
111–31) amends the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to
grant FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health and to reduce
tobacco use by minors.
The purpose of this submission is to
request OMB approval to conduct Webbased surveys to evaluate the relative
effectiveness of various graphic health
warnings on cigarette packs, which will
inform the Agency’s efforts to
implement the mandatory graphic
warnings required by the Tobacco
Control Act.
Experimental Study of Graphic
Cigarette Warning Labels (OMB Control
Number 0910–0668—Reinstatement)
The current approval for this
information collection expired October
31, 2012. FDA seeks to reinstate the
collection and to reflect that there is no
change in the reporting burden. At this
time, the Agency is not collecting the
information, but awaits OMB review
and approval, and therefore believes
that we are not in violation of the PRA.
Tobacco products are responsible for
more than 400,000 deaths each year.
The Centers for Disease Control and
Prevention report that approximately 46
million U.S. adults smoke cigarettes in
the United States, even though this
behavior will result in death or
disability for half of all regular users.
Paralleling this enormous health burden
is the economic burden of tobacco use,
which is estimated to total $193 billion
annually in medical expenditures and
lost productivity. Curbing the
significant adverse consequences of
tobacco use is one of the most important
public health goals of our time.
On June 22, 2009, the President
signed the Tobacco Control Act (Pub. L.
111–31) into law. The Tobacco Control
Act granted FDA authority to regulate
the manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 201 of the Tobacco Control Act,
which amends section 4 of the Federal
Cigarette Labeling and Advertising Act
(15 U.S.C. 1333), requires FDA to issue
‘‘regulations that require color graphics
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
depicting the negative health
consequences of smoking to accompany
the label statements specified in
subsection (a)(1).’’ The study proposed
here is an effort by FDA to collect data
concerning graphic warnings on
cigarette packages and their impact on
consumer perceptions, attitudes, and
behavior with respect to smoking.
On June 22, 2011, FDA issued a final
rule in the Federal Register of June 22,
2011 (76 FR 36628), entitled ‘‘Required
Warnings for Cigarette Packages and
Advertisements,’’ which specified nine
graphic images to accompany the new
textual warnings for cigarettes.
Although the rule was scheduled to
become effective 15 months after it
issued, a panel of the U.S. Court of
Appeals of the District of Columbia
held, on August 24, 2012, that the rule
in its current form violates the First
Amendment. FDA expects that the
information that FDA proposes to
collect will be relevant to FDA’s
regulation of cigarette warnings no
matter the final outcome of the current
litigation.
This study, the Experimental Study of
Graphic Cigarette Warning Labels, is a
voluntary annual experimental survey
of consumers. The purpose of the study
is to assess the effectiveness of various
graphic warnings on cigarette packs for
achieving three communication goals:
(1) Conveying information about various
health risks of smoking; (2) encouraging
cessation of smoking among current
smokers; and (3) discouraging initiation
of smoking among youth and former
smokers. The study will collect data
from various groups of consumers,
including current smokers aged 13 years
and older, former smokers aged 13 years
and older, and non-smokers aged
between 13 and 25 years who may be
susceptible to initiation of smoking. The
study goals are to: (1) Measure
consumer attitudes, beliefs, and
intended behaviors related to cigarette
smoking in response to graphic warning
labels; (2) determine whether consumer
responses to graphic warning labels
differ across various groups based on
smoking status, age, or other
demographic variables; and (3) evaluate
the relative effectiveness of various
graphic images associated with each of
the nine warning statements specified in
E:\FR\FM\05DEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72353-72355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29327]
[[Page 72353]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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, Ila.Mizrachi@fda.hhs.gov.
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 https://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
[[Page 72354]]
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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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[[Page 72355]]
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
