Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development, 38211-38212 [2015-16358]
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Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1167]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Controlled
Correspondence Related to Generic
Drug Development
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 August 3,
2015.
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
title. Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
Guidance for Industry on Controlled
Correspondence Related to Generic
Drug Development OMB Control
Number 0910–NEW
In the Federal Register of August 27,
2014 (79 FR 51180), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Controlled
Correspondence Related to Generic Drug
Development.’’ The draft guidance
provided information regarding the
process by which human generic drug
manufacturers and related industry can
submit correspondence to FDA
requesting information on generic drug
development. This guidance also
VerDate Sep<11>2014
21:16 Jul 01, 2015
Jkt 235001
described FDA’s process for providing
communications related to such
correspondence.
On July 9, 2012, the Generic Drug
User Fee Amendments of 2012 (GDUFA)
were signed into law by the President to
speed the delivery of safe and effective
generic drugs to the public and to
reduce costs to industry. Under GDUFA,
FDA agreed to certain obligations as laid
out in the GDUFA Commitment Letter
that accompanies the legislation (Ref. 1).
The GDUFA Commitment Letter
described controlled correspondence as
follows: ‘‘FDA’s Office of Generic Drugs
provides assistance to pharmaceutical
firms and related industry regarding a
variety of questions posed as ‘controlled
documents.’ See https://www.fda.gov/
AboutFDA/CentersOffices/
officeofmedicalproductsandtobacco/
CDER/ucm120610.htm (Ref. 2).
Controlled correspondence does not
include citizen petitions, petitions for
reconsideration, or requests for stay.’’
The draft guidance is intended to
further refine this description to best
support the aims identified in the
GDUFA Commitment Letter of ensuring
the safety of generic drug products;
enhancing access by expediting the
availability of these products; and
enhancing transparency by, among other
things, improving FDA’s
communications and feedback with
industry in order to expedite product
access. In addition, this guidance
provides detail and recommendations
concerning what inquiries FDA
considers as controlled correspondence
for the purposes of meeting the
Agency’s GDUFA commitment, what
information requestors can include in a
controlled correspondence to facilitate
FDA’s consideration of and response to
a controlled correspondence, and what
information FDA will provide in its
communications to entities that have
submitted a controlled correspondence.
Under GDUFA, FDA has agreed to
specific program enhancements and
performance goals specified in the
GDUFA Commitment Letter. One of the
performance goals applies to controlled
correspondence related to generic drug
development. The Commitment Letter
includes details on FDA’s commitment
to respond to questions submitted as
controlled correspondence within
certain time frames. To facilitate FDA’s
prompt consideration of the controlled
correspondence and response, and to
assist in meeting the prescribed time
frames, FDA recommends including the
following information in the inquiry: (1)
Name, title, address, phone number, and
entity of the person submitting the
inquiry; (2) an email address; (3) an
FDA-assigned control number and
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
38211
submission date of any previous related
correspondence, if applicable; (4) the
relevant reference listed drug, as
applicable, including the application
number, proprietary (brand) name,
manufacturer, active ingredient, dosage
form, and strength(s); (5) a concise
statement of the inquiry; (6) a
recommendation of the appropriate FDA
review discipline; and (7) relevant prior
research and supporting materials.
In the Federal Register of August 27,
2014 (79 FR 51180), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received several
comments pertaining to the scope of
controlled correspondence. We
summarize the comments and provide
our response below:
(Comment) Several comments
expressed concern related to three types
of requests that FDA proposed to
exclude from the definition of
controlled correspondence. The three
exclusions are: (1) Requests for
recommendations on the appropriate
design of bioequivalence (BE) studies
for a specific drug product (BE guidance
requests); (2) requests for review of BE
clinical protocols (clinical protocol
requests); and (3) requests for meetings
to discuss generic drug development
prior to ANDA submission (pre-ANDA
meeting requests).
(Response) FDA has not changed its
policy regarding its consideration of
requests for bioequivalence guidance,
clinical protocol reviews, and preANDA meetings. FDA will consider
them promptly upon their electronic
submission and will respond as
expeditiously as practicable. Although
the guidance states that these requests
are not considered controlled
correspondence submissions, requests
for BE guidance and pre-ANDA
meetings are included in the 1,020 total
annual responses estimated in table 1
because these requests will utilize the
same information collection pathway as
a request that is considered controlled
correspondence. For reasons described
in the draft guidance, however,
controlled correspondence GDUFA
metrics will not apply to FDA’s
responses to the three excluded
requests.
The following information is based on
inquiries considered controlled
correspondence and submitted to FDA
for FYs 2011, 2012, and 2013. FDA
estimates approximately 217 generic
drug manufacturers and related industry
(e.g., contract research organizations
conducting bioanalytical or
bioequivalence clinical trials) or their
representatives would each submit an
average of 4.7 inquiries annually for a
E:\FR\FM\02JYN1.SGM
02JYN1
38212
Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
total of 1,020 inquiries (1,020 ÷ 217 =
4.7). Information submitted with each
inquiry varies widely in content,
depending on the complexity of the
request. Inquiries that are defined as
controlled correspondence (i.e.,
inquiries that request information on a
specific element of generic drug product
development) may range from a simple
inquiry on generic drug labeling to a
more complex inquiry for a formulation
assessment for a specific proposed
generic drug product. As a result, these
inquiries can vary between 1 to 10
burden hours, respectively.
Because the content of inquiries
considered controlled correspondence is
widely varied, we are providing an
average burden hour for each inquiry.
We estimate that it will take an average
of 5 hours per inquiry for industry to
gather necessary information, prepare
the request, and submit the request to
FDA. As a result, we estimate that it will
take an average of 5,100 total hours
annually for industry to prepare and
submit inquiries considered controlled
correspondence.
Description of Respondents:
Respondents are human generic drug
manufacturers and related industry.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Submission of controlled correspondence
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Manufacturers, Related Industry, and Representatives ......
217
4.7
1,020
5
5,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
1. ‘‘Generic Drug User Fee Act Program
Performance Goals and Procedures’’
(GDUFA Commitment Letter) for
fiscal years 2013 through 2017,
available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
GenericDrugUserFees/
UCM282505.pdf).
2. Id. at p. 15. The Web page quoted in
the controlled correspondence
definition has been updated as the
link provided in the GDUFA
Commitment Letter is no longer
accessible.
Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16358 Filed 7–1–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2008]
Unapproved and Misbranded Otic
Prescription Drug Products;
Enforcement Action Dates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing its intention to take
enforcement action against unapproved
and misbranded otic drug products
labeled for prescription use and
containing benzocaine; benzocaine and
antipyrine; benzocaine, antipyrine, and
zinc acetate; benzocaine, chloroxylenol,
and hydrocortisone; chloroxylenol and
pramoxine; or chloroxylenol,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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21:16 Jul 01, 2015
Jkt 235001
pramoxine, and hydrocortisone; and
against persons who manufacture or
cause the manufacture or distribution of
such products in interstate commerce.
These unapproved and misbranded
prescription drug products are marketed
without evidence of safety and
effectiveness; may present safety
concerns; and pose a direct challenge to
the new drug approval system and, in
some cases, the over-the-counter (OTC)
drug monograph system.
DATES: This notice is effective July 2,
2015. For information about
enforcement dates, see SUPPLEMENTARY
INFORMATION, section IV.
ADDRESSES: For all communications in
response to this notice, identify with
Docket No. FDA–2015–N–2008 and
direct to the appropriate office listed in
this ADDRESSES section as follows:
Applications under section 505(b) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 355(b)):
Division of Anesthesia, Analgesia, and
Addiction Products (for drug products
with analgesic and anti-inflammatory
indications), or Division of AntiInfective Drug Products (for drug
products with anti-infective
indications), Office of New Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Silver Spring, MD
20993–0002.
Applications under section 505(j) of
the FD&C Act: Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Silver Spring, MD
20993–0002.
All other communications about this
action should be directed to: Kathleen
Joyce, Division of Prescription Drugs,
Office of Unapproved Drugs and
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Labeling Compliance, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5236,
Silver Spring, MD 20993–0002; 301–
796–3329 or email: Kathleen.Joyce@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Kathleen Joyce, Division of Prescription
Drugs, Office of Unapproved Drugs and
Labeling Compliance, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5236,
Silver Spring, MD 20993–0002; 301–
796–3329 or email: Kathleen.Joyce@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing its intention to
take enforcement action against certain
unapproved and misbranded otic drug
products labeled for prescription use.
These marketed unapproved and
misbranded otic drug products are
labeled for, among other things, the
temporary relief of pain associated with
ear infections or inflammation,
including acute otitis media (middle ear
infection), otitis media with effusion
(fluid in the ear, but without infection),
and acute otitis externa (infection in the
outer ear or ‘‘swimmer’s ear’’). Other
indications for these unapproved drug
products include anti-infective and antiinflammatory claims, as well as claims
for the removal of cerumen (earwax).
This notice covers the following
marketed unapproved prescription otic
drug products: (1) Single-ingredient otic
drug products containing benzocaine;
(2) fixed-dose combination otic drug
products containing benzocaine and
antipyrine; (3) fixed-dose combination
otic drug products containing
benzocaine, antipyrine, and zinc
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38211-38212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16358]
[[Page 38211]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1167]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Controlled Correspondence Related to Generic Drug Development
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
3, 2015.
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 title. Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Guidance for Industry on Controlled Correspondence Related to Generic
Drug Development OMB Control Number 0910-NEW
In the Federal Register of August 27, 2014 (79 FR 51180), FDA
announced the availability of a draft guidance for industry entitled
``Controlled Correspondence Related to Generic Drug Development.'' The
draft guidance provided information regarding the process by which
human generic drug manufacturers and related industry can submit
correspondence to FDA requesting information on generic drug
development. This guidance also described FDA's process for providing
communications related to such correspondence.
On July 9, 2012, the Generic Drug User Fee Amendments of 2012
(GDUFA) were signed into law by the President to speed the delivery of
safe and effective generic drugs to the public and to reduce costs to
industry. Under GDUFA, FDA agreed to certain obligations as laid out in
the GDUFA Commitment Letter that accompanies the legislation (Ref. 1).
The GDUFA Commitment Letter described controlled correspondence as
follows: ``FDA's Office of Generic Drugs provides assistance to
pharmaceutical firms and related industry regarding a variety of
questions posed as `controlled documents.' See https://www.fda.gov/AboutFDA/CentersOffices/officeofmedicalproductsandtobacco/CDER/ucm120610.htm (Ref. 2). Controlled correspondence does not include
citizen petitions, petitions for reconsideration, or requests for
stay.'' The draft guidance is intended to further refine this
description to best support the aims identified in the GDUFA Commitment
Letter of ensuring the safety of generic drug products; enhancing
access by expediting the availability of these products; and enhancing
transparency by, among other things, improving FDA's communications and
feedback with industry in order to expedite product access. In
addition, this guidance provides detail and recommendations concerning
what inquiries FDA considers as controlled correspondence for the
purposes of meeting the Agency's GDUFA commitment, what information
requestors can include in a controlled correspondence to facilitate
FDA's consideration of and response to a controlled correspondence, and
what information FDA will provide in its communications to entities
that have submitted a controlled correspondence.
Under GDUFA, FDA has agreed to specific program enhancements and
performance goals specified in the GDUFA Commitment Letter. One of the
performance goals applies to controlled correspondence related to
generic drug development. The Commitment Letter includes details on
FDA's commitment to respond to questions submitted as controlled
correspondence within certain time frames. To facilitate FDA's prompt
consideration of the controlled correspondence and response, and to
assist in meeting the prescribed time frames, FDA recommends including
the following information in the inquiry: (1) Name, title, address,
phone number, and entity of the person submitting the inquiry; (2) an
email address; (3) an FDA-assigned control number and submission date
of any previous related correspondence, if applicable; (4) the relevant
reference listed drug, as applicable, including the application number,
proprietary (brand) name, manufacturer, active ingredient, dosage form,
and strength(s); (5) a concise statement of the inquiry; (6) a
recommendation of the appropriate FDA review discipline; and (7)
relevant prior research and supporting materials.
In the Federal Register of August 27, 2014 (79 FR 51180), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received several comments pertaining to
the scope of controlled correspondence. We summarize the comments and
provide our response below:
(Comment) Several comments expressed concern related to three types
of requests that FDA proposed to exclude from the definition of
controlled correspondence. The three exclusions are: (1) Requests for
recommendations on the appropriate design of bioequivalence (BE)
studies for a specific drug product (BE guidance requests); (2)
requests for review of BE clinical protocols (clinical protocol
requests); and (3) requests for meetings to discuss generic drug
development prior to ANDA submission (pre-ANDA meeting requests).
(Response) FDA has not changed its policy regarding its
consideration of requests for bioequivalence guidance, clinical
protocol reviews, and pre-ANDA meetings. FDA will consider them
promptly upon their electronic submission and will respond as
expeditiously as practicable. Although the guidance states that these
requests are not considered controlled correspondence submissions,
requests for BE guidance and pre-ANDA meetings are included in the
1,020 total annual responses estimated in table 1 because these
requests will utilize the same information collection pathway as a
request that is considered controlled correspondence. For reasons
described in the draft guidance, however, controlled correspondence
GDUFA metrics will not apply to FDA's responses to the three excluded
requests.
The following information is based on inquiries considered
controlled correspondence and submitted to FDA for FYs 2011, 2012, and
2013. FDA estimates approximately 217 generic drug manufacturers and
related industry (e.g., contract research organizations conducting
bioanalytical or bioequivalence clinical trials) or their
representatives would each submit an average of 4.7 inquiries annually
for a
[[Page 38212]]
total of 1,020 inquiries (1,020 / 217 = 4.7). Information submitted
with each inquiry varies widely in content, depending on the complexity
of the request. Inquiries that are defined as controlled correspondence
(i.e., inquiries that request information on a specific element of
generic drug product development) may range from a simple inquiry on
generic drug labeling to a more complex inquiry for a formulation
assessment for a specific proposed generic drug product. As a result,
these inquiries can vary between 1 to 10 burden hours, respectively.
Because the content of inquiries considered controlled
correspondence is widely varied, we are providing an average burden
hour for each inquiry. We estimate that it will take an average of 5
hours per inquiry for industry to gather necessary information, prepare
the request, and submit the request to FDA. As a result, we estimate
that it will take an average of 5,100 total hours annually for industry
to prepare and submit inquiries considered controlled correspondence.
Description of Respondents: Respondents are human generic drug
manufacturers and related industry.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Submission of controlled correspondence Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers, Related Industry, and Representatives............... 217 4.7 1,020 5 5,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
1. ``Generic Drug User Fee Act Program Performance Goals and
Procedures'' (GDUFA Commitment Letter) for fiscal years 2013 through
2017, available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf).
2. Id. at p. 15. The Web page quoted in the controlled correspondence
definition has been updated as the link provided in the GDUFA
Commitment Letter is no longer accessible.
Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16358 Filed 7-1-15; 8:45 am]
BILLING CODE 4164-01-P
