[Federal Register Volume 86, Number 176 (Wednesday, September 15, 2021)]
[Notices]
[Page 51451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19880]


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DEPARTMENT OF THE TREASURY

Internal Revenue Service


Proposed Collection; Comment Request for Information Collection 
Tool Relating to the Orphan Drug Credit

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Notice and request for comments.

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SUMMARY: The Internal Revenue Service, as part of its continuing effort 
to reduce paperwork and respondent burden, invites the general public 
and other Federal agencies to take this opportunity to comment on 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. The IRS is soliciting comments concerning the 
orphan drug credit.

DATES: Written comments should be received on or before November 15, 
2021 to be assured of consideration.

ADDRESSES: Direct all written comments to Kinna Brewington, Internal 
Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 
20224.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or 
copies of the form should be directed to Kerry Dennis, at (202) 317-
5751 or Internal Revenue Service, Room 6526, 1111 Constitution Avenue 
NW, Washington, DC 20224, or through the internet, at 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Title: Orphan Drug Credit.
    OMB Number: 1545-1505.
    Form Number: 8820.
    Abstract: Filers use this form to elect to claim the orphan drug 
credit, which is 50% of the qualified clinical testing expenses paid or 
incurred with respect to low or unprofitable drugs for rare diseases 
and conditions, as designated under section 526 of the Federal Food, 
Drug, and Cosmetic Act.
    Current Actions: There is no change in the form or paperwork burden 
previously approved by OMB.
    Type of Review: Extension of a currently approved collection.
    Affected Public: Business or other for-profit organizations.
    Estimated Number of Respondents: 67.
    Estimated Time per Response: 4 hours, 42 min.
    Estimated Total Annual Burden Hours: 316.
    The following paragraph applies to all the collections of 
information covered by this notice.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless the collection of 
information displays a valid OMB control number. Books or records 
relating to a collection of information must be retained if their 
contents may become material in the administration of any internal 
revenue law. Generally, tax returns and tax return information are 
confidential, as required by 26 U.S.C. 6103.
    Request for Comments: Comments submitted in response to this notice 
will be summarized and/or included in the request for OMB approval. All 
comments will become a matter of public record. Comments are invited 
on: (a) Whether the collection of information is necessary for the 
proper performance of the functions of the agency, including whether 
the information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the collection of information; (c) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; (d) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques or other forms of information technology; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information.

    Approved: September 2, 2021.
ChaKinna B. Clemons,
Supervisory Tax Analyst.
[FR Doc. 2021-19880 Filed 9-14-21; 8:45 am]
BILLING CODE 4830-01-P