82 FR 28860 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 121 (June 26, 2017)

Page Range		28860-28861
FR Document		2017-13245

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.

Federal Register, Volume 82 Issue 121 (Monday, June 26, 2017)

[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28860-28861]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1066]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Annual Reporting for 
Custom Device Exemption

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 July 
26, 2017.

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 0910-0767. 
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, 10A63, 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.

Annual Reporting for Custom Device Exemption OMB Control Number 0910-
0767--Extension

    The custom device exemption is set forth at section 520(b)(2)(B) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
360j(b)(2)(B)). A custom device is in a narrow category of device that, 
by virtue of the rarity of the patient's medical condition or 
physician's special need the device is designed to treat, it would be 
impractical for the device to comply with premarket review regulations 
and performance standards.
    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
implemented changes to the custom device exemption contained in section 
520(b) of the FD&C Act. The new provision amended the existing custom 
device exemption and introduced new concepts and procedures for custom 
devices, such as:
     Devices created or modified in order to comply with the 
order of an individual physician or dentist;

[[Page 28861]]

     The potential for multiple units of a device type (limited 
to no more than five units per year) qualifying for the custom device 
exemption; and
     Annual reporting requirements by the manufacturer to FDA 
about devices manufactured and distributed under section 520(b) of the 
FD&C Act.
    Under FDASIA, ``devices'' that qualify for the custom device 
exemption contained in section 520(b) of the FD&C Act were clarified to 
include no more than ``five units per year of a particular device 
type'' that otherwise meet all the requirements necessary to qualify 
for the custom device exemption.
    In the Federal Register of September 24, 2014 (79 FR 57112), FDA 
announced the availability of the guidance entitled ``Custom Device 
Exemption.'' FDA has developed this document to provide guidance to 
industry and FDA staff about implementation of the custom device 
exemption contained in the FD&C Act. The intent of the guidance is to 
define terms used in the custom device exemption, explain how to 
interpret the ``five units per year of a particular device type'' 
language contained in the FD&C Act, describe information that FDA 
proposes manufacturers should submit in the custom device annual 
report, and provide recommendations on how to submit an annual report 
for devices distributed under the custom device exemption.
    In the Federal Register of March 21, 2017 (82 FR 14518), 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Annual reporting for custom                   33               1              33              40           1,320
 devices........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13245 Filed 6-23-17; 8:45 am]
 BILLING CODE 4164-01-P

28860 Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

530.22(b), Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden for this information priority review vouchers to sponsors of (OMB) for review and clearance under
collection has not changed since the last approved rare pediatric disease product the Paperwork Reduction Act of 1995.
OMB approval. applications that meet certain criteria. DATES: Fax written comments on the
Dated: June 20, 2017. FDA has determined that Brineura collection of information by July 26,
Anna K. Abram,
(cerliponase alfa) manufactured by 2017.
Biomarin Pharmaceuticals Inc., meets ADDRESSES: To ensure that comments on
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
the criteria for a priority review the information collection are received,
voucher. Brineura (cerliponase alfa) is OMB recommends that written
[FR Doc. 2017–13296 Filed 6–23–17; 8:45 am]
indicated to slow the progression of loss comments be faxed to the Office of
BILLING CODE 4164–01–P
of ambulation in symptomatic pediatric Information and Regulatory Affairs,
patients 3 years of age and older with OMB, Attn: FDA Desk Officer, FAX:
DEPARTMENT OF HEALTH AND late infantile neuronal ceroid 202–395–7285, or emailed to oira_
HUMAN SERVICES lipofuscinosis type 2 (CLN2), also submission@omb.eop.gov. All
known as tripeptidyl peptidase 1 (TPP1) comments should be identified with the
Food and Drug Administration deficiency. OMB control number 0910–0767. Also
For further information about the Rare include the FDA docket number found
[Docket No. FDA–2017–N–0809] Pediatric Disease Priority Review in brackets in the heading of this
Voucher Program and for a link to the document.
Issuance of Priority Review Voucher;
full text of section 529 of the FD&C Act,
Rare Pediatric Disease Product FOR FURTHER INFORMATION CONTACT:
go to https://www.fda.gov/ForIndustry/
AGENCY: Food and Drug Administration, DevelopingProductsf Amber Sanford, Office of Operations,
HHS. orRareDiseasesConditions/ Food and Drug Administration, Three
RarePediatricDisease White Flint North, 10A63, 11601
ACTION: Notice.
PriorityVoucherProgram/default.htm. Landsdown St., North Bethesda, MD
SUMMARY: The Food and Drug For further information about Brineura 20852, 301–796–8867, PRAStaff@
Administration (FDA) is announcing the (cerliponase alfa) go to the ‘‘Drugs@ fda.hhs.gov.
issuance of a priority review voucher to FDA’’ Web site at https:// SUPPLEMENTARY INFORMATION: In
the sponsor of a rare pediatric disease www.accessdata.fda.gov/scripts/cder/ compliance with 44 U.S.C. 3507, FDA
product application. The Federal Food, daf/. has submitted the following proposed
Drug, and Cosmetic Act (the FD&C Act), Dated: June 20, 2017. collection of information to OMB for
as amended by the Food and Drug review and clearance.
Anna K. Abram,
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award Deputy Commissioner for Policy, Planning, Annual Reporting for Custom Device
Legislation, and Analysis. Exemption OMB Control Number 0910–
priority review vouchers to sponsors of
approved rare pediatric disease product [FR Doc. 2017–13236 Filed 6–23–17; 8:45 am] 0767—Extension
applications that meet certain criteria. BILLING CODE 4164–01–P The custom device exemption is set
FDA is required to publish notice of the forth at section 520(b)(2)(B) of the
award of the priority review voucher. Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND (the FD&C Act) (21 U.S.C. 360j(b)(2)(B)).
FDA has determined that Brineura
HUMAN SERVICES A custom device is in a narrow category
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets Food and Drug Administration of device that, by virtue of the rarity of
the criteria for a priority review the patient’s medical condition or
voucher. physician’s special need the device is
[Docket No. FDA–2017–N–1066]
designed to treat, it would be
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection impractical for the device to comply
Althea Cuff, Center for Drug Evaluation
Activities; Submission for Office of with premarket review regulations and
and Research, Food and Drug
Management and Budget Review; performance standards.
Administration, 10903 New Hampshire
Comment Request; Annual Reporting The Food and Drug Administration
Ave., Bldg. 22, Rm. 6484, Silver Spring,
for Custom Device Exemption Safety and Innovation Act (FDASIA)
MD 20993–0002, 301–796–4061, FAX:
implemented changes to the custom
301–796–9858, email: althea.cuff@
AGENCY: Food and Drug Administration, device exemption contained in section
fda.hhs.gov.
sradovich on DSK3GMQ082PROD with NOTICES

HHS. 520(b) of the FD&C Act. The new
SUPPLEMENTARY INFORMATION: FDA is ACTION: Notice. provision amended the existing custom
announcing the issuance of a priority device exemption and introduced new
review voucher to the sponsor of an SUMMARY: The Food and Drug concepts and procedures for custom
approved rare pediatric disease product Administration (FDA) is announcing devices, such as:
application. Under section 529 of the that a proposed collection of • Devices created or modified in
FD&C Act (21 U.S.C. 360ff), which was information has been submitted to the order to comply with the order of an
added by FDASIA, FDA will award Office of Management and Budget individual physician or dentist;

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Document Created: 2018-11-14 10:10:19
Document Modified: 2018-11-14 10:10:19

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 July 26, 2017.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		82 FR 28860

82 FR 28860 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 121 (June 26, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration