82 FR 58424 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 237 (December 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 237 (December 12, 2017)
| Page Range | 58424-58425 | |
| FR Document | 2017-26669 |
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)] [Notices] [Pages 58424-58425] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26669] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation 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 January 11, 2018. 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 emailed 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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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 Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation (Formerly Orphan Drugs; Common European Medicines Agency/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-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 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, FDA estimates that there will be one respondent to Sec. Sec. 316.10, 316.12, and 316.14 requiring 50 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. Based on past experience, FDA estimates 496 respondents to Sec. Sec. 316.20, 316.21, and 316.26, requiring 83,700 hours of human resources annually. The Common EMEA/FDA Application for Orphan Medicinal Product Designation form for orphan designation of drugs intended for rare diseases or conditions (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 Orphan Drug Designation Request Form (Form FDA 4035) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from only FDA. The form is a simplified method for sponsors to provide only information required by 21 CFR 316.20 for FDA to make a decision. Based on past experience, FDA estimates there will be 496 respondents using the form requiring 19,840 hours of human resources annually. Section 316.22 specifies requirement of a permanent resident agent for foreign sponsors. Based on past experience, FDA estimates 70 respondents requiring 140 hours of human resources annually. [[Page 58425]] Section 316.24(a) specifies a requirement that sponsors respond to deficiency letters from FDA on designation requests within 1 year of issuance of the deficiency letter, unless within that time frame, the sponsor requests an extension of time to respond. Based on past experience, FDA estimates 20 respondents requiring 40 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 63 respondents requiring 315 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 744 requiring 2,232 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 two respondents requiring 90 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 June 19, 2017 (82 FR 27836), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR section/Form FDA Number of frequency per Total annual Hours per Total hours respondents response responses response ---------------------------------------------------------------------------------------------------------------- Content and format when seeking 1 1 1 50 50 written recommendations; results of studies; and amendments (Sec. Sec. 316.10, 316.12, and 316.14).... Content and format of a request 496 1.25 620 135 83,700 for designation; request for verification of status; amendment to designation....... Form FDA 3671 or 4035 FDA Orphan 1.25 620 32 19,840 Drug Designation Request Form (Sec. Sec. 316.20, 316.21, and 316.26).................... Notifications of changes in 70 1 70 2 140 agents (Sec. 316.22)......... Deficiency letters and granting 20 1 20 2 40 orphan-drug designation (Sec. 316.24(a))..................... Submissions to change ownership 63 1 63 5 315 of orphan-drug designation (Sec. 316.27)................ Annual reports (Sec. 316.30).. 744 1 744 3 2,232 Assurance of the availability of 2 3 6 15 90 sufficient quantities of the orphan drug; holder's consent for the approval of other marketing applications for the same drug (Sec. 316.36)...... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 106,407 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA has experienced increases in: (1) The number of submissions to change ownership of orphan-drug designation (Sec. 316.27), (2) the number of annual reports (Sec. 316.30), and (3) assurances of the availability of sufficient quantities of the orphan drug and the holder's consent for the approval of other marketing applications for the same drug (Sec. 316.36). Dated: December 6, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26669 Filed 12-11-17; 8:45 am] BILLING CODE 4164-01-P
![58424 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
approve, modify, or disapprove the Information and Regulatory Affairs, providing such recommendations, FDA
collections of information, including OMB, Attn: FDA Desk Officer, Fax: 202– may require results of studies to be
OMB control number(s) for newly 395–7285, or emailed to oira_ submitted for review. Section 316.14
approved collections. submission@omb.eop.gov. All contains provisions permitting FDA to
This guidance also refers to comments should be identified with the refuse to provide written
previously approved collections of OMB control number 0910–0167. Also recommendations under certain
information found in FDA regulations. include the FDA docket number found circumstances. Within 90 days of any
The collections of information in brackets in the heading of this refusal, a sponsor may submit
associated with 21 CFR 202.1 have been document. additional information specified by
approved under OMB control number FDA. Based on past experience, FDA
FOR FURTHER INFORMATION CONTACT:
0910–0686. estimates that there will be one
Amber Sanford, Office of Operations,
respondent to §§ 316.10, 316.12, and
III. Electronic Access Food and Drug Administration, Three
316.14 requiring 50 hours of human
Persons with access to the internet White Flint North, 10A–12M, 11601
resources annually.
may obtain the guidance at https:// Landsdown St., North Bethesda, MD Section 316.20 specifies the content
www.fda.gov/Drugs/Guidance 20852, 301–796–8867, PRAStaff@ and format of an orphan drug
ComplianceRegulatoryInformation/ fda.hhs.gov. application which includes
Guidances/default.htm, https://www. SUPPLEMENTARY INFORMATION: In requirements that an applicant
fda.gov/BiologicsBloodVaccines/ compliance with 44 U.S.C. 3507, FDA document that the disease is rare (affects
GuidanceComplianceRegulatory has submitted the following proposed fewer than 200,000 persons in the
Information/default.htm, https:// collection of information to OMB for United States annually) or that the
www.fda.gov/AnimalVeterinary/ review and clearance. sponsor of the drug has no reasonable
GuidanceComplianceEnforcement/ expectation of recovering costs of
Orphan Products Development; Food research and development of the drug.
GuidanceforIndustry/default.htm, or
and Drug Administration Orphan Drug Section 316.21 specifies content of a
https://www.regulations.gov.
Designation Request Form and The request for orphan drug designation
Dated: December 7, 2017. Common European Medicines Agency/ required for verification of orphan-drug
Leslie Kux, Food and Drug Administration Form status. Section 316.26 allows an
Associate Commissioner for Policy. for Orphan Medicinal Product applicant to amend the applications
[FR Doc. 2017–26725 Filed 12–11–17; 8:45 am] Designation (Formerly Orphan Drugs; under certain circumstances. Based on
BILLING CODE 4164–01–P Common European Medicines Agency/ past experience, FDA estimates 496
FDA Application Form for Orphan respondents to §§ 316.20, 316.21, and
Medicinal Product Designation (Form 316.26, requiring 83,700 hours of
DEPARTMENT OF HEALTH AND FDA 3671))—21 CFR Part 316 human resources annually.
HUMAN SERVICES OMB Control Number 0910–0167— The Common EMEA/FDA
Extension Application for Orphan Medicinal
Food and Drug Administration Product Designation form for orphan
[Docket No. FDA–2011–N–0015]
Sections 525 through 528 of the designation of drugs intended for rare
Federal Food, Drug, and Cosmetic Act diseases or conditions (Form FDA 3671)
Agency Information Collection (the FD&C Act) (21 U.S.C. 360aa–360dd) is intended to benefit sponsors who
Activities; Submission for Office of give FDA statutory authority to do the desire to seek orphan designation of
Management and Budget Review; following: (1) Provide recommendations drugs intended for rare diseases or
Comment Request; Orphan Products on investigations required for approval conditions from both the European
Development; Food and Drug of marketing applications for orphan Commission and FDA by reducing the
Administration Orphan Drug drugs, (2) designate eligible drugs as burden of preparing separate
Designation Request Form and The orphan drugs, (3) set forth conditions applications to meet the regulatory
Common European Medicines Agency/ under which a sponsor of an approved requirements in each jurisdiction. It
Food and Drug Administration Form orphan drug obtains exclusive approval, highlights the regulatory cooperation
for Orphan Medicinal Product and (4) encourage sponsors to make between the United States and the
Designation orphan drugs available for treatment on European Union mandated by the
an ‘‘open protocol’’ basis before the drug Transatlantic Economic Council. The
AGENCY: Food and Drug Administration, has been approved for general FDA Orphan Drug Designation Request
HHS. marketing. The implementing Form (Form FDA 4035) is intended to
ACTION: Notice. regulations for these statutory benefit sponsors who desire to seek
requirements have been codified under orphan designation of drugs intended
SUMMARY: The Food and Drug part 316 (21 CFR part 316) and specify for rare diseases or conditions from only
Administration (FDA) is announcing procedures that sponsors of orphan FDA. The form is a simplified method
that a proposed collection of drugs use in availing themselves of the for sponsors to provide only information
information has been submitted to the incentives provided for orphan drugs in required by 21 CFR 316.20 for FDA to
Office of Management and Budget the FD&C Act and sets forth procedures make a decision. Based on past
(OMB) for review and clearance under FDA will use in administering the FD&C experience, FDA estimates there will be
the Paperwork Reduction Act of 1995. Act with regard to orphan drugs. 496 respondents using the form
ethrower on DSK3G9T082PROD with NOTICES
DATES: Fax written comments on the Section 316.10 specifies the content requiring 19,840 hours of human
collection of information by January 11, and format of a request for written resources annually.
2018. recommendations concerning the Section 316.22 specifies requirement
ADDRESSES: To ensure that comments on nonclinical laboratory studies and of a permanent resident agent for foreign
the information collection are received, clinical investigations necessary for sponsors. Based on past experience,
OMB recommends that written approval of marketing applications. FDA estimates 70 respondents requiring
comments be faxed to the Office of Section 316.12 provides that, before 140 hours of human resources annually.
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![Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58425
Section 316.24(a) specifies a reports on studies, a description of the disease or condition and satisfies the
requirement that sponsors respond to investigational plan, and a discussion of requirements for obtaining orphan drug
deficiency letters from FDA on changes that may affect orphan status. status. Secondly, the information will
designation requests within 1 year of Based on number of orphan-drug describe the medical and regulatory
issuance of the deficiency letter, unless designations, the number of respondents history of the drug. The respondents to
within that time frame, the sponsor is estimated as 744 requiring 2,232 this collection of information are
requests an extension of time to hours of human resources annually. biotechnology firms, drug companies,
respond. Based on past experience, FDA Finally, § 316.36 describes information and academic clinical researchers.
estimates 20 respondents requiring 40 required of sponsor when there is
In the Federal Register of June 19,
hours of human resources annually. insufficient quantity of approved
Section 316.27 specifies content of a 2017 (82 FR 27836), FDA published a
orphan drug. Based on past experience,
change in ownership of orphan-drug FDA estimates two respondents 60-day notice requesting public
designation. Based on past experience, requiring 90 hours of human resources comment on the proposed collection of
FDA estimates 63 respondents requiring annually. information. No comments were
315 hours of human resources annually. The information requested will received.
Section 316.30 requires submission of provide the basis for an FDA FDA estimates the burden of this
annual reports, including progress determination that the drug is for a rare collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Total annual Hours per Total
21 CFR section/Form FDA frequency
respondents responses response hours
per response
Content and format when seeking written recommenda-
tions; results of studies; and amendments (§§ 316.10,
316.12, and 316.14) ......................................................... 1 1 1 50 50
Content and format of a request for designation; request
for verification of status; amendment to designation ....... 496 1.25 620 135 83,700
Form FDA 3671 or 4035 FDA Orphan Drug Designation
Request Form (§§ 316.20, 316.21, and 316.26) .............. 1.25 620 32 19,840
Notifications of changes in agents (§ 316.22) ..................... 70 1 70 2 140
Deficiency letters and granting orphan-drug designation
(§ 316.24(a)) ..................................................................... 20 1 20 2 40
Submissions to change ownership of orphan-drug des-
ignation (§ 316.27) ............................................................ 63 1 63 5 315
Annual reports (§ 316.30) .................................................... 744 1 744 3 2,232
Assurance of the availability of sufficient quantities of the
orphan drug; holder’s consent for the approval of other
marketing applications for the same drug (§ 316.36) ...... 2 3 6 15 90
Total .............................................................................. ........................ ........................ ........................ ........................ 106,407
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has experienced increases in: (1) DEPARTMENT OF HEALTH AND including each proposed extension of an
The number of submissions to change HUMAN SERVICES existing collection of information, and
ownership of orphan-drug designation to allow 60 days for public comment in
(§ 316.27), (2) the number of annual Food and Drug Administration response to the notice. This notice
reports (§ 316.30), and (3) assurances of solicits comments on information
[Docket No. FDA–2017–N–6397]
the availability of sufficient quantities of collection provisions for calorie labeling
the orphan drug and the holder’s Agency Information Collection of articles of food in vending machines.
consent for the approval of other Activities; Proposed Collection; DATES: Submit either electronic or
marketing applications for the same Comment Request; Food Labeling; written comments on the collection of
drug (§ 316.36). Calorie Labeling of Articles of Food in information by February 12, 2018.
Dated: December 6, 2017. Vending Machines
ADDRESSES: You may submit comments
Leslie Kux, AGENCY: Food and Drug Administration, as follows. Please note that late,
Associate Commissioner for Policy. HHS. untimely filed comments will not be
[FR Doc. 2017–26669 Filed 12–11–17; 8:45 am] ACTION: Notice. considered. Electronic comments must
be submitted on or before February 12,
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug 2018. The https://www.regulations.gov
Administration (FDA or Agency) is electronic filing system will accept
announcing an opportunity for public comments until midnight Eastern Time
ethrower on DSK3G9T082PROD with NOTICES
comment on the proposed collection of at the end of February 12, 2018.
certain information by the Agency. Comments received by mail/hand
Under the Paperwork Reduction Act of delivery/courier (for written/paper
1995 (PRA), Federal Agencies are submissions) will be considered timely
required to publish notice in the if they are postmarked or the delivery
Federal Register concerning each service acceptance receipt is on or
proposed collection of information, before that date.
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Document Created: 2018-10-25 10:48:48
Document Modified: 2018-10-25 10:48:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by January 11, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 58424 |
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