[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Pages 230-231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10]



Food and Drug Administration
[Docket No. 97N-0513]

Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on provisions concerning orphan 

DATES: Submit written comments on the collection of information by 
March 6, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 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 reinstatement 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 listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

[[Page 231]]

Orphan Drugs--(21 CFR Part 316)--(OMB Control Number 0910-0167--

    Sections 525 through 528 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360aa through 360dd) give the FDA statutory 
authority to: (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 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. 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 application 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.
    FDA estimates the burden of this collection of information as 

                                  Table 1.--Estimated Annual Reporting Burden1                                  
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
316.10, 316.12, and 316.14              0               0               0               0               0       
316.20, 316.21, and 316.26             90               1.78          160.20          125          20,025       
316.22                                  5               1               5               2              10       
316.27                                  5               1               5               4              20       
316.30                                450               1             450               2             900       
316.36                                   .2             3                .6            15               9       
Total                                                                                              20,964       
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            

    The information requested from respondents represents, for the most 
part, an accounting of information already in possession of the 
applicant. It is estimated, based on the frequency of requests over the 
past 5 years, that 90 persons or organizations per year will request 
orphan drug designation and that no requests for recommendations on 
design of preclinical or clinical studies will be received. Based upon 
FDA experience over the last decade, FDA estimates that the effort 
required to prepare applications to receive consideration for sections 
525 and 526 of the act (21 CFR 316.10, 316.12, 316.20, and 316.21) is 
generally similar and is estimated to require an average of 95 hours of 
professional staff time and 30 hours of support staff time per 
application. Estimates of annual activity and burden for foreign 
sponsor nomination of a resident, agent, change in ownership or 
designation, and inadequate supplies of drug in exclusivity, are based 
on total experience by FDA with such requests since 1983.

    Dated: December 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-10 Filed 1-2-98; 8:45 am]