[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Pages 63615-63616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0430]


Agency Emergency Processing Under Office of Management and Budget 
Review; Orphan Drug Products; Common European Medicines Evaluation 
Agency/Food and Drug Administration Application Form for Orphan 
Medicinal Product Designation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information is an amendment to OMB control number 0910-0167 and 
concerns the joint adoption by FDA and the European Medicines 
Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for 
Orphan Medicinal Product Designation (form FDA 3671).

DATES: Fax written comments on the collection of information by 
November 19, 2007.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number ``0910-0167'' and the 
title, ``Orphan Drug Products; Common EMEA/FDA Application Form for 
Orphan Medicinal Product Designation.'' Also include the FDA docket 
number found in brackets in the heading of this document. To obtain a 
copy of the draft form FDA 3671, please call Mary Grice at 301-827-3666 
or submit written requests via fax to 301-827-0017.

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: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13) to enable the agency to 
jointly announce with EMEA the adoption of the Common EMEA/FDA 
Application Form for Orphan Medicinal Product Designation at the 
European Union (EU)-wide Administrative Simplification Workshop on 
November 28, 2007. The information is essential to the agency's mission 
of protecting and promoting the public health. The use of the normal 
clearance procedures would likely result in the prevention or 
disruption of this collection of information.
    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 Drug Products; Common EMEA/FDA Application Form for Orphan 
Medicinal Product Designation--(OMB Congrol Number 0910-0167)--
Amendment

    This common application form 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 and EU mandated by the 
Transatlantic Economic Council (TEC). The TEC mandate involves: Removal 
of barriers to transatlantic commerce; rationalizing, reforming, and, 
where appropriate, reducing regulations to empower the private sector; 
achieving more effective, systematic, and transparent regulatory 
cooperation to reduce costs associated with regulation to consumers and 
producers; removing unnecessary differences between jurisdictional 
regulations in order to foster economic integration; reinforcing the 
existing transatlantic dialogue structures in regulatory cooperation, 
both by intensifying our sector-by-sector United States-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 United States and in the European Community, a sponsor 
must submit a designation request to FDA (in accordance with section 
526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb)) 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 a 
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,\1\ FDA and EMEA have agreed in principle to adopt a template 
for the common application form as proposed in form FDA 3671.
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    \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 http://www.fda.gov/oia/arrangements0904.html.
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    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 common application form when seeking designation only from FDA. 
This

[[Page 63616]]

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 as, at 
the extreme, all respondent are U.S.-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. The collection of information for sponsors 
requesting orphan drug designation from FDA is currently covered by the 
Orphan Drug Regulations (21 CFR Part 316) and approved under OMB No. 
0910-0167 (expires August 31, 2010). 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.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                          Annual No. of      Annual Frequency       Total Annual        Hours per
                     FDA Form No.                          Respondents         per Response          Responses           Response         Total Hours
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FDA 3671                                                               40                     1                 40                 32              1,280
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: November 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21988 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S