Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671), 2504-2507 [E8-571]
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Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices
• Provide the business’ gross receipts
or sales for the most recent year, in both
the local currency and in U.S. dollars,
and the exchange rate used in
converting local currency to U.S.
dollars;
• Provide the dates during which the
reported receipts or sales were
collected; and
• Bear the official seal of the national
taxing authority.
business by submitting a certification
from its national taxing authority, the
foreign equivalent of our Internal
Revenue Service. This certification,
referred to as a ‘‘National Taxing
Authority Certification,’’ must:
• Be in English;
• Be from the national taxing
authority of the country in which the
business is headquartered;
The new FDA Form 3602A, ‘‘FY 2008
MDUFMA Foreign Small Business
Qualification Certification,’’ will collect
the information required by the statute
and allows a foreign business to qualify
for the same small business benefits as
a domestic U.S. business.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
FDA Form 3602A
Sections I and II (completed by the
business seeking small business status)
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
229
1
229
1
229
33
7
231
1
231
Section III (completed by the foreign
national taxing authority)
Total
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1 There
460
are no capital costs or operating and maintenance costs associated with this collection of information.
This burden estimate is based on an
examination of 510(k) premarket
notifications received during FY 2006
and FDA’s estimation of the time to
collect the required information to
complete FDA Form 3602A. The
evidence supporting each FDA Form
3602A must be reviewed by a foreign
national taxing authority to complete
Section III, the National Taxing
Authority Certification, of each FDA
Form 3602A. Because this is a new
activity, and neither FDA nor any
foreign national taxing authority has any
data that would provide an objective
measure of the effort required to
complete Section III, FDA is estimating
that the burden will be the same as FDA
experiences in reviewing FDA Form
3602, ‘‘FY 2008 MDUFMA Small
Business Qualification Certification For
a Business Headquartered in the United
States,’’ approved under OMB control
number 0910–0508.
FDA believes most entities that
submit FDA Form 3602A will not have
any affiliates, and very few will have
more than three or four affiliates. Based
on our experience with FDA Form 3602,
FDA believes each business will require
1 hour to complete Sections I and II.
Because this is a new requirement, FDA
does not have any data on the time that
will be required to complete Section III,
the National Taxing Authority
Certification.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
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date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
Dated: January 9, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–569 Filed 1–14–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N–0007]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Orphan Drugs;
Common European Medicines Agency/
Food and Drug Administration
Application Form for Orphan Medicinal
Product Designation (Form FDA 3671)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
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information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the procedures by which sponsors of
orphan drugs may request eligibility for
the incentives by implementing a
program as outlined in the Orphan Drug
Act and the joint adoption by FDA and
the European Medicines Agency
(EMEA) of the Common EMEA/FDA
Application Form for Orphan Medicinal
Product Designation (form FDA 3671).
DATES: Submit written or electronic
comments on the collection of
information by March 17, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or https://
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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices
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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 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 collection of
information, FDA invites comments on
these topics: (1) the clarity and ease of
use of this proposed common
application form; (2) whether the
proposed collection of information is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(3) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(4) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (5) ways to minimize the
burden of the collection of information
on respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology.
Orphan Drugs; Common EMEA/FDA
Application Form for Orphan
Medicinal Product Designation (Form
FDA 3671) (OMB Control Number
0910–0167)—Extension
Sections 525 and 526 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360aa and 360dd) give FDA
statutory authority to do the following:
(1) Provide recommendations on
investigations required for approval of
marketing applications for orphan
drugs, (2) designate eligible drugs as
orphan drugs, (3) set forth conditions
under which a sponsor of an approved
orphan drug obtains exclusive approval,
and (4) encourage sponsors to make
orphan drugs available for treatment on
an ‘‘open protocol’’ basis before the drug
has been approved for general
marketing. The implementing
regulations for these statutory
requirements have been codified under
part 316 (21 CFR part 316) and specify
procedures that sponsors of orphan
drugs use in availing themselves of the
incentives provided for orphan drugs in
the act and sets forth procedures FDA
will use in administering the act with
regard to orphan drugs. Section 316.10
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specifies the content and format of a
request for written recommendations
concerning the non-clinical laboratory
studies and clinical investigations
necessary for approval of marketing
applications. Section 316.12 provides
that, before providing such
recommendations, FDA may require
results of studies to be submitted for
review. Section 316.14 contains
provisions permitting FDA to refuse to
provide written recommendations under
certain circumstances. Within 90 days
of any refusal, a sponsor may submit
additional information specified by
FDA. Section 316.20 specifies the
content and format of an orphan drug
application which includes
requirements that an applicant
document that the disease is rare (affects
fewer than 200,000 persons in the
United States annually) or that the
sponsor of the drug has no reasonable
expectation of recovering costs of
research and development of the drug.
Section 316.26 allows an applicant to
amend the applications under certain
circumstances. Section 316.30 requires
submission of annual reports, including
progress reports on studies, a
description of the investigational plan,
and a discussion of changes that may
affect orphan status. The information
requested will provide the basis for an
FDA determination that the drug is for
a rare disease or condition and satisfies
the requirements for obtaining orphan
drug status. Secondly, the information
will describe the medical and regulatory
history of the drug. The respondents to
this collection of information are
biotechnology firms, drug companies,
and academic clinical researchers.
The information requested from
respondents represents, for the most
part, an accounting of information
already in the possession of the
applicant. It is estimated, based on
frequency of requests over the past 5
years, that 171 persons or organizations
per year will request orphan-drug
designation and none will request
formal recommendations on design of
preclinical or clinical studies.
The Common EMEA/FDA
Application Form for Orphan Medicinal
Product Designation (form FDA 3671) is
intended to benefit sponsors who desire
to seek orphan designation of drugs
intended for rare diseases or conditions
from both the European Commission
and FDA by reducing the burden of
preparing separate applications to meet
the regulatory requirements in each
jurisdiction. It highlights the regulatory
cooperation between the United States
(US) and the European Union (EU)
mandated by the Transatlantic
Economic Council (TEC). The TEC
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2505
mandate involves the following: (1)
Removal of barriers to transatlantic
commerce; (2) rationalizing, reforming,
and, where appropriate, reducing
regulations to empower the private
sector; (3) achieving more effective,
systematic, and transparent regulatory
cooperation to reduce costs associated
with regulation to consumers and
producers; (4) removing unnecessary
differences between jurisdictional
regulations to foster economic
integration; and (5) reinforcing the
existing transatlantic dialogue structures
in regulatory cooperation, both by
intensifying our sector-by-sector US-EU
regulatory cooperation and our dialogue
between OMB and the European
Commission services on methodological
issues.
At present, when seeking orphan
designation of the same drug for the
diagnosis, treatment, or prevention of
the same rare disease or condition in the
US and in the European Community, a
sponsor must submit a designation
request to FDA (in accordance with
section 526 of the act) and a separate
designation application to EMEA (in
accordance with Regulation (EC) No.
141/2000 of December 16, 1999, and
Commission Regulation (EC) No. 847/
2000). In most cases, the two documents
are formatted differently to meet
regulatory demands, but the required
core information elements are similar,
with the exception of some unique
regulatory requirements exclusive to
each jurisdiction. Therefore, FDA and
EMEA believe that a common
application form will help reduce the
sponsor’s regulatory burden and costs to
produce and submit differentlyformatted request/application. In
addition, a common application form
may also streamline the administrative
and substantive regulatory review
processes, and aid in information
exchange between the agencies. In
accordance with the Confidentiality
Arrangements concluded on September
12, 2003, between the European
Commission, EMEA, and FDA/
Department of Health and Human
Services (DHHS),1 FDA and EMEA have
agreed in principle to adopt a template
for the common application form as
proposed in form FDA 3671.
Any sponsor seeking orphan
designation of the same drug for the
same disease or condition from both
FDA and EMEA may use this common
application form for regulatory filing
purposes. A sponsor may also use this
1 See ‘‘Confidentiality Arrangements Concluded
Between the EU (EC and EMEA) and the US FDA/
DHHS Implementation Plan for Medicinal Products
for Human Use’’ at https://www.fda.gov/oia/
arrangements0904.html.
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Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices
common application form when seeking
designation only from FDA. This
common application form is intended to
complement, not to supersede, the
relevant regulatory frameworks
currently in effect. The sponsor must
comply with all applicable regulatory
requirements in each jurisdiction in
which it seeks designation when using
this common application form.
To use the common application form,
the sponsor must provide the required
information in each applicable section
as instructed in the explanatory notes.
Certain information elements are
identified in the form as required
exclusively by either FDA or EMEA
regulations, and as such they must be
included only in the application to that
jurisdiction. Where additional
explanations and/or supportive
documents are necessary, the sponsor
should sequentially append them at the
end of the common application form in
the order they appear in the form. The
sponsor must also complete the
declaration and signature page. For
FDA, the completed common
application form and required appended
documents must be submitted to the
Office of Orphan Products Development
(HF–35), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. For EMEA, the
completed documents must be
submitted to European Medicines
Agency, 7 Westferry Circus, Canary
Wharf, London E14 4HB, United
Kingdom.
FDA estimates the reporting burden of
this common application form as
follows. Between January 2000 and May
2006, FDA and EMEA received 226
comparable orphan designation
requests/applications of the same drugs
for the same diseases or conditions, or
an average of 35 per year. With the ease
of a common application form, FDA
anticipates the number of such requests/
applications may increase over time.
Therefore, generally there is one
request/application per respondent and,
at the extreme, all respondent are USbased, FDA believes up to 40 such
respondents may use the common
application form each year. The
respondents will be primarily
pharmaceutical companies or other forprofit organizations. For applications
submitted exclusively to FDA, we do
not believe the new form will result in
any increased burden on the
respondents and therefore we estimate
no additional burden for those
respondents. FDA believes the
information required for the EMEA
submission, for the most part, is very
similar to that in the FDA submission,
which is already in the respondents’
possession. The respondents, however,
may have to search existing data sources
or gather additional needed data, such
as on the prevalence or the availability
of alternative methods of diagnosis,
prevention, and treatment of the rare
disease or condition of interest in the
European Community, to complete the
EMEA submission. FDA estimates that it
will take an additional 32 hours—16
hours of professional time and 16 hours
of support time—to compile information
required for the EMEA submission.
Hence, the estimated total annual
human resource hours, at most, would
be 1,280 hours for the EMEA
submission.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section and FDA Form
Annual No. of
Respondents
Annual Frequency per
Response
Total Annual
Responses
Hours per Response
Total Hours
316.10,
316.12,
316.14
5
1
5
130
650
316.20,
316.21,
316.26
171
2.0
342
130
44,460
316.20,
316.21,
316.26
40
1
40
32
1,280
316.22
30
1
30
2
60
316.30
500
1
500
2
1,000
316.36
.2
3
.6
15
9
Form FDA 3671
Total
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1There
47,559
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
Dated: January 7, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–571 Filed 1–14–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2007N–0240]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Patent Term Restoration, Due
Diligence Petitions, Filing, Format, and
Content of Petitions
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Patent Term Restoration, Due Diligence
Petitions, Filing, Format, and Content of
Petitions’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
SUMMARY:
In the
Federal Register of October 11, 2007 (72
FR 57950), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0233. The
approval expires on January 31, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: January 9, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–573 Filed 1–14–08; 8:45 am]
Food and Drug Administration
AGENCY:
Lane, Rockville, MD 20857, 301–827–
4816.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committees; Tentative
Schedule of Meetings for 2008
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
tentative schedule of forthcoming
meetings of its public advisory
committees for 2008. During 1991, at the
request of the Commissioner of Food
and Drugs (the Commissioner), the
Institute of Medicine (the IOM)
conducted a study of the use of FDA’s
advisory committees. In its final report,
Committee Name
one of the IOM’s recommendations was
for the agency to publish an annual
tentative schedule of its meetings in the
Federal Register. This publication
implements the IOM’s recommendation.
FOR FURTHER INFORMATION CONTACT:
Theresa L. Green, Advisory Committee
Oversight and Management Staff (HF–
4), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–1220.
The IOM,
at the request of the Commissioner,
undertook a study of the use of FDA’s
advisory committees. In its final report
in 1992, one of the IOM’s
recommendations was for FDA to adopt
a policy of publishing an advance yearly
schedule of its upcoming public
advisory committee meetings in the
Federal Register; FDA has implemented
this recommendation. The annual
publication of tentatively scheduled
advisory committee meetings will
provide both advisory committee
members and the public with the
opportunity, in advance, to schedule
attendance at FDA’s upcoming advisory
committee meetings. Because the
schedule is tentative, amendments to
this notice will not be published in the
Federal Register. However, changes to
the schedule will be posted on the FDA
advisory committees’ Internet site
located at https://www.fda.gov/oc/
advisory/default.htm. FDA will
continue to publish a Federal Register
notice 15 days in advance of each
upcoming advisory committee meeting,
to announce the meeting (21 CFR 14.20).
The following list announces FDA’s
tentatively scheduled advisory
committee meetings for 2008. You may
also obtain up-to-date information by
calling the Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area).
SUPPLEMENTARY INFORMATION:
Tentative Date of Meeting(s)
Advisory Committee
10-Digit Information
Line Code
OFFICE OF THE COMMISSIONER
Pediatric Advisory Committee
March and November days to be announced
8732310001
Risk Communication Advisory Committee
February 28–29, May 15–16, August 21–22, November
17–18
8732112560
Science Board to FDA
May and October days to be announced
3014512603
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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
Allergenic Products Advisory Committee
April 29, October 17
3014512388
Blood Products Advisory Committee
May 1–2, August 14–15, December 11–12
3014519516
Cellular, Tissue and Gene Therapies Advisory Committee
April 10–11, November 13–14
3014512389
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]]>Agencies
[Federal Register Volume 73, Number 10 (Tuesday, January 15, 2008)]
[Notices]
[Pages 2504-2507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N-0007]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Orphan Drugs; Common European Medicines Agency/Food
and Drug Administration Application Form for Orphan Medicinal Product
Designation (Form FDA 3671)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 procedures by which
sponsors of orphan drugs may request eligibility for the incentives by
implementing a program as outlined in the Orphan Drug Act and the joint
adoption by FDA and the European Medicines Agency (EMEA) of the Common
EMEA/FDA Application Form for Orphan Medicinal Product Designation
(form FDA 3671).
DATES: Submit written or electronic comments on the collection of
information by March 17, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments or https://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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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
[[Page 2505]]
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
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 collection of information, FDA invites comments
on these topics: (1) the clarity and ease of use of this proposed
common application form; (2) whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (3) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (4) ways to enhance the quality, utility, and clarity of the
information to be collected; and (5) ways to minimize the burden of the
collection of information on respondents, including the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Orphan Drugs; Common EMEA/FDA Application Form for Orphan Medicinal
Product Designation (Form FDA 3671) (OMB Control Number 0910-0167)--
Extension
Sections 525 and 526 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360aa and 360dd) give FDA statutory authority to
do the following: (1) Provide recommendations on investigations
required for approval of marketing applications for orphan drugs, (2)
designate eligible drugs as orphan drugs, (3) set forth conditions
under which a sponsor of an approved orphan drug obtains exclusive
approval, and (4) encourage sponsors to make orphan drugs available for
treatment on an ``open protocol'' basis before the drug has been
approved for general marketing. The implementing regulations for these
statutory requirements have been codified under part 316 (21 CFR part
316) and specify procedures that sponsors of orphan drugs use in
availing themselves of the incentives provided for orphan drugs in the
act and sets forth procedures FDA will use in administering the act
with regard to orphan drugs. Section 316.10 specifies the content and
format of a request for written recommendations concerning the non-
clinical laboratory studies and clinical investigations necessary for
approval of marketing applications. Section 316.12 provides that,
before providing such recommendations, FDA may require results of
studies to be submitted for review. Section 316.14 contains provisions
permitting FDA to refuse to provide written recommendations under
certain circumstances. Within 90 days of any refusal, a sponsor may
submit additional information specified by FDA. Section 316.20
specifies the content and format of an orphan drug application which
includes requirements that an applicant document that the disease is
rare (affects fewer than 200,000 persons in the United States annually)
or that the sponsor of the drug has no reasonable expectation of
recovering costs of research and development of the drug. Section
316.26 allows an applicant to amend the applications under certain
circumstances. Section 316.30 requires submission of annual reports,
including progress reports on studies, a description of the
investigational plan, and a discussion of changes that may affect
orphan status. The information requested will provide the basis for an
FDA determination that the drug is for a rare disease or condition and
satisfies the requirements for obtaining orphan drug status. Secondly,
the information will describe the medical and regulatory history of the
drug. The respondents to this collection of information are
biotechnology firms, drug companies, and academic clinical researchers.
The information requested from respondents represents, for the most
part, an accounting of information already in the possession of the
applicant. It is estimated, based on frequency of requests over the
past 5 years, that 171 persons or organizations per year will request
orphan-drug designation and none will request formal recommendations on
design of preclinical or clinical studies.
The Common EMEA/FDA Application Form for Orphan Medicinal Product
Designation (form FDA 3671) is intended to benefit sponsors who desire
to seek orphan designation of drugs intended for rare diseases or
conditions from both the European Commission and FDA by reducing the
burden of preparing separate applications to meet the regulatory
requirements in each jurisdiction. It highlights the regulatory
cooperation between the United States (US) and the European Union (EU)
mandated by the Transatlantic Economic Council (TEC). The TEC mandate
involves the following: (1) Removal of barriers to transatlantic
commerce; (2) rationalizing, reforming, and, where appropriate,
reducing regulations to empower the private sector; (3) achieving more
effective, systematic, and transparent regulatory cooperation to reduce
costs associated with regulation to consumers and producers; (4)
removing unnecessary differences between jurisdictional regulations to
foster economic integration; and (5) reinforcing the existing
transatlantic dialogue structures in regulatory cooperation, both by
intensifying our sector-by-sector US-EU regulatory cooperation and our
dialogue between OMB and the European Commission services on
methodological issues.
At present, when seeking orphan designation of the same drug for
the diagnosis, treatment, or prevention of the same rare disease or
condition in the US and in the European Community, a sponsor must
submit a designation request to FDA (in accordance with section 526 of
the act) and a separate designation application to EMEA (in accordance
with Regulation (EC) No. 141/2000 of December 16, 1999, and Commission
Regulation (EC) No. 847/2000). In most cases, the two documents are
formatted differently to meet regulatory demands, but the required core
information elements are similar, with the exception of some unique
regulatory requirements exclusive to each jurisdiction. Therefore, FDA
and EMEA believe that a common application form will help reduce the
sponsor's regulatory burden and costs to produce and submit
differently-formatted request/application. In addition, a common
application form may also streamline the administrative and substantive
regulatory review processes, and aid in information exchange between
the agencies. In accordance with the Confidentiality Arrangements
concluded on September 12, 2003, between the European Commission, EMEA,
and FDA/Department of Health and Human Services (DHHS),\1\ FDA and EMEA
have agreed in principle to adopt a template for the common application
form as proposed in form FDA 3671.
---------------------------------------------------------------------------
\1\ See ``Confidentiality Arrangements Concluded Between the EU
(EC and EMEA) and the US FDA/DHHS Implementation Plan for Medicinal
Products for Human Use'' at https://www.fda.gov/oia/
arrangements0904.html.
---------------------------------------------------------------------------
Any sponsor seeking orphan designation of the same drug for the
same disease or condition from both FDA and EMEA may use this common
application form for regulatory filing purposes. A sponsor may also use
this
[[Page 2506]]
common application form when seeking designation only from FDA. This
common application form is intended to complement, not to supersede,
the relevant regulatory frameworks currently in effect. The sponsor
must comply with all applicable regulatory requirements in each
jurisdiction in which it seeks designation when using this common
application form.
To use the common application form, the sponsor must provide the
required information in each applicable section as instructed in the
explanatory notes. Certain information elements are identified in the
form as required exclusively by either FDA or EMEA regulations, and as
such they must be included only in the application to that
jurisdiction. Where additional explanations and/or supportive documents
are necessary, the sponsor should sequentially append them at the end
of the common application form in the order they appear in the form.
The sponsor must also complete the declaration and signature page. For
FDA, the completed common application form and required appended
documents must be submitted to the Office of Orphan Products
Development (HF-35), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. For EMEA, the completed documents must be
submitted to European Medicines Agency, 7 Westferry Circus, Canary
Wharf, London E14 4HB, United Kingdom.
FDA estimates the reporting burden of this common application form
as follows. Between January 2000 and May 2006, FDA and EMEA received
226 comparable orphan designation requests/applications of the same
drugs for the same diseases or conditions, or an average of 35 per
year. With the ease of a common application form, FDA anticipates the
number of such requests/applications may increase over time. Therefore,
generally there is one request/application per respondent and, at the
extreme, all respondent are US-based, FDA believes up to 40 such
respondents may use the common application form each year. The
respondents will be primarily pharmaceutical companies or other for-
profit organizations. For applications submitted exclusively to FDA, we
do not believe the new form will result in any increased burden on the
respondents and therefore we estimate no additional burden for those
respondents. FDA believes the information required for the EMEA
submission, for the most part, is very similar to that in the FDA
submission, which is already in the respondents' possession. The
respondents, however, may have to search existing data sources or
gather additional needed data, such as on the prevalence or the
availability of alternative methods of diagnosis, prevention, and
treatment of the rare disease or condition of interest in the European
Community, to complete the EMEA submission. FDA estimates that it will
take an additional 32 hours--16 hours of professional time and 16 hours
of support time--to compile information required for the EMEA
submission. Hence, the estimated total annual human resource hours, at
most, would be 1,280 hours for the EMEA submission.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual No. of Annual Frequency per Total Annual Hours per
21 CFR Section and FDA Form Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.10, 5 1 5 130 650
316.12,
316.14
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.20, 171 2.0 342 130 44,460
316.21,
316.26
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.20, 40 1 40 32 1,280
316.21,
316.26
................. .................... ................. ................. .................
Form FDA 3671
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.22 30 1 30 2 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.30 500 1 500 2 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.36 .2 3 .6 15 9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 47,559
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 2507]]
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
Dated: January 7, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-571 Filed 1-14-08; 8:45 am]
BILLING CODE 4160-01-S
