[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Pages 28043-28045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11744]



Food and Drug Administration

[Docket No. FDA-2011-N-0015]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 June 
13, 2011.

[[Page 28044]]

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 e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0167. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, [email protected]

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:

Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal 
Product Designation (Form FDA 3671)--21 CFR Part 316--(OMB Control 
Number 0910-0167)--Extension

    Sections 525 through 528 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360aa through 360 dd) 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 FD& C Act and sets forth procedures FDA will use in 
administering the FD& C Act with regard to orphan drugs. Section 316.10 
specifies the content and format of a request for written 
recommendations concerning the nonclinical 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. Based on past experience, the FDA estimates that 
there will be two respondents to Sec. Sec.  316.10, 316.12, and 316.14 
requiring 200 hours of human resources annually.
    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 316.21 specifies content of a request for orphan drug 
designation required for verification of orphan-drug status. Section 
316.26 allows an applicant to amend the applications under certain 
circumstances. The Common European Medicines Agency (EMA)/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 and the European Union mandated by the Transatlantic 
Economic Council. The FDA does not believe the new form will result in 
any increased burden on the respondents and therefore we estimate no 
additional burden. Based on past experience, FDA estimates there will 
be 214 respondents requiring 64,200 hours of human resources annually. 
Section 316.22 specifies requirement of a permanent resident agent for 
foreign sponsors. Based on past experience, FDA estimates 55 
respondents requiring 110 hours of human resources annually. Section 
316.27 specifies content of a change in ownership of orphan-drug 
designation. Based on past experience, FDA estimates 43 respondents 
requiring 215 hours of human resources annually. 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. Based on number of orphan-drug 
designations, the number of respondents is estimated as 1,652 requiring 
4,956 hours of human resources annually. Finally, Sec.  316.36 
describes information required of sponsor when there is insufficient 
quantity of approved orphan drug. Based on past experience, FDA 
estimates 1 respondent requiring 45 hours of human resources annually.
    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.
    In the Federal Register of January 21, 2011 (76 FR 3910), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
    FDA estimates the burden of this collection of information as 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                                     Number of                        Average
   21 CFR section and FDA form       Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
316.10, 316.12, and 316.14......               2               1               2             100             200
316.20, 316.21, and 316.26 Form              214               2             428             150          64,200
 FDA 3671.......................
316.22..........................              55               1              55               2             110
316.27..........................              43               1              43               5             215
316.30..........................           1,652               1           1,652               3           4,956
316.36..........................               1               3               3              15              45
    Total.......................  ..............  ..............  ..............  ..............          69,726
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

[[Page 28045]]

    Dated: May 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11744 Filed 5-12-11; 8:45 am]