Custom Device Exemption; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 2446-2448 [2014-00528]

Download as PDF 2446 Federal Register / Vol. 79, No. 9 / Tuesday, January 14, 2014 / Notices to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–00414 Filed 1–13–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.568] Reallotment of FY 2013 Funds for the Low Income Home Energy Assistance Program (LIHEAP) Office of Community Services, ACF, HHS. ACTION: Notice of determination concerning funds available for reallotment. AGENCY: Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2013 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal Organizations that receive FY 2014 direct LIHEAP grants. No subgrantees or other entities may apply for these funds. Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), Title XXVI of the Omnibus Budget Reconciliation Act of 1981 (42 U.S.C. 8621 et seq.), as amended, requires that if the Secretary of the U.S. Department of Health and Human Services (HHS) determines that, as of September 1 of any fiscal year, an amount in excess of certain levels allotted to a grantee for any fiscal year will not be used by the grantee during the fiscal year, the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be realloted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. (No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2014.) It has been determined that $2,192,230 may be available for reallotment during FY 2014. This determination is based on revised Carryover and Reallotment Reports from the State of Nebraska, Salt River PimaMaricopa Indian Community, and the Delaware Tribe of Indians, which were submitted to the Office of Community Services as required by 45 CFR 96.82. The statute allows grantees who have funds unobligated at the end of the emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:32 Jan 13, 2014 Jkt 232001 federal fiscal year for which they are awarded to request that they be allowed to carry over up to 10 percent of their allotments to the next federal fiscal year. Funds in excess of this amount must be returned to HHS and are subject to reallotment under section 2607(b)(1) of the Act. The amount described in this notice was reported as unobligated FY 2013 funds in excess of the amount that the State of Nebraska, Salt River PimaMaricopa Indian Community, and the Delaware Tribe of Indians could carry over to FY 2014. Each of the grantees mentioned above were notified and confirmed that the FY 2013 funds indicated in the chart below may be reallotted. In accordance with section 2607(b)(3), the Chief Executive Officers of the grantees referenced in the chart below have 30 days from the date of this publication to submit comments to: Jeannie L. Chaffin, Director, Office of Community Services, 370 L’Enfant Promenade, SW., Washington, DC 20447. After considering any comments submitted, the Chief Executive Officers will be notified of the final reallotment amount, and this decision also will be published in the Federal Register. If funds are reallotted, they will be allocated in accordance with section 2604 of the Act and must be treated by LIHEAP grantees receiving them as an amount appropriated for FY 2014. As FY 2014 funds, they will be subject to all requirements of the Act, including section 2607(b)(2), which requires that a grantee obligate at least 90 percent of its total block grant allocation for a fiscal year by the end of the fiscal year for which the funds are appropriated, that is, by September 30, 2014. Statutory Authority: 45 CFR 96.81 and 42 U.S.C. 8621 et seq. ´ Lynda Perez, Acting Director, Office of Community Services. [FR Doc. 2014–00520 Filed 1–13–14; 8:45 am] BILLING CODE 4184–80–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1601] Custom Device Exemption; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Custom Device Exemption.’’ FDA has developed a draft guidance to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). The intent of this guidance is to provide draft definitions of 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 what information 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. This draft guidance is not final nor is it in effect at this time. ESTIMATED REALLOTMENT AMOUNTS DATES: Although you can comment on OF FY 2013 LIHEAP FUNDS any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency FY 2013 Grantee name reallotment considers your comment of this draft amount guidance before it begins work on the final version of the guidance, submit State of Nebraska ............... $2,180,356.00 Delaware Tribe of Indians .. 9,793.00 either electronic or written comments on the draft guidance by March 17, Salt River Pima-Maricopa Indian Community ........... 2,081.00 2014. ADDRESSES: Submit written requests for Total ................................ 2,192,230.00 single copies of the draft guidance document entitled ‘‘Custom Device DATES: The comment period expires Exemption’’ to the Division of Small February 13, 2014. Manufacturers, International, and FOR FURTHER INFORMATION CONTACT: Consumer Assistance, Center for Lauren Christopher, Energy Program Devices and Radiological Health, Food Operations Branch Chief, Division of and Drug Administration, 10903 New Energy Assistance, Office of Community Hampshire Ave., Bldg. 66, Rm. 4613, Services, 370 L’Enfant Promenade, SW., Silver Spring, MD 20993–0002. Send Washington, DC, 20447; telephone (202) one self-addressed adhesive label to 401–4870; email: assist that office in processing your lauren.christopher@acf.hhs.gov. request, or fax your request to 301–847– PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\14JAN1.SGM 14JAN1 Federal Register / Vol. 79, No. 9 / Tuesday, January 14, 2014 / Notices plans to interpret the concept of ‘‘five units per year of a particular device type’’ in section 520(b)(2)(B) of the FD&C Act, describes what information manufacturers should submit in a custom device annual report (annual report) to FDA, and provides guidance on how to submit an annual report for devices distributed under the custom device exemption. On November 19, 2012, FDA published a Notice of Request for Comments in the Federal Register (77 FR 69488), requesting stakeholders to submit information on and examples of appropriate use of the custom device exemption for assistance in drafting this guidance based on specific questions asked in the Notice. FDA has reviewed all the comments from the Notice and has taken them into consideration for this draft guidance. I. Background emcdonald on DSK67QTVN1PROD with NOTICES 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Erin Keith, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1404, Silver Spring, MD 20993–0002, 301–796–6384, CustomDevices@fda.hhs.gov. SUPPLEMENTARY INFORMATION: II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the custom device exemption. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. The custom device exemption is set forth at section 520(b)(2)(B) of 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. Effective on July 9, 2012, 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; • 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. The guidance also provides draft definitions of terms used in the custom device exemption, explains how FDA VerDate Mar<15>2010 16:32 Jan 13, 2014 Jkt 232001 III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Custom Device Exemption,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1820 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 2447 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 before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (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. Draft Guidance for Custom Device Exemption This guidance is intended to assist industry by providing draft definitions of terms used in the custom device exemption, explains how FDA proposes to interpret the ‘‘five units per year of a particular device type’’ language contained in section 520(b)(2)(B) of the FD&C Act, describes what information FDA proposes should be submitted in a custom device annual report, and provides recommendations on how to submit an annual report in preparing for annual reports for devices distributed under the custom device exemption. In addition, manufacturers of custom devices are required to sign and submit a Custom Devices Annual Report Truthful and Accurate certificate with their annual report. Description of Respondents: The respondents of this collection of information are manufacturers of medical devices deemed to be custom devices subject to FDA’s laws and regulations. The Agency estimates the burden of this collection of information as follows: E:\FR\FM\14JAN1.SGM 14JAN1 2448 Federal Register / Vol. 79, No. 9 / Tuesday, January 14, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Guidance title: Custom device exemption Number of respondents Number of responses per respondent Total annual responses Average burden per response (in hours) Total hours Section VI. Annual Reporting .............................................. 33 1 33 40 1,320 emcdonald on DSK67QTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates it will receive 33 reports for custom devices annually. The Agency reached this estimate by the number of pre-FDASIA manufacturers who qualified for custom devices and that percentage of current manufactures that qualify under post-FDASIA requirements. Only 10 percent of manufacturers would meet this qualification, which was calculated by adding the number of estimated old custom device manufactures with the estimated new manufacturers submitting annual reports of custom devices each year. FDA estimates it will take custom device manufacturers approximately 40 hours to complete the annual report described in section VI of the draft guidance. FDA reached this time estimate based on its expectation of the amount of information that should be included in the report. Before the proposed information collection provisions contained in this draft guidance become effective, FDA will publish a notice in the Federal Register announcing OMB’s decision to approve, modify, or disapprove the information collection provisions. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it display a currently valid OMB control number. This draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA (44 U.S.C. 3501–3520). The collections of information in 21 CFR 814, subparts B and E have been approved under OMB control number 0910–0231; the collections of information in 21 part 812 have been approved under OMB control number 0910–0078; and the collections of information in 21 part 807, subpart E have been approved under OMB control number 0910–0120. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of VerDate Mar<15>2010 16:32 Jan 13, 2014 Jkt 232001 comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: January 9, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–00528 Filed 1–13–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1622] Draft Guidance for Industry: Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format.’’ The draft guidance is intended to alert stakeholders to changes we are planning for the administrative procedures currently used by commercial processors that manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as ‘‘low-acid canned foods’’ or ‘‘LACF’’). These changes include new food process filing forms and a new ‘‘smart form’’ system for electronic submission of these forms. The draft guidance, when finalized, will supersede the July 2012 guidance entitled ‘‘Guidance for SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format’’ when the new food process filing forms and the new ‘‘smart form’’ electronic system become operational. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by March 17, 2014. ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS–302), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Susan Brecher, Center for Food Safety and Applied Nutrition (HFS–302), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1781. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format.’’ The draft guidance is intended to alert stakeholders to changes we are planning for the administrative procedures currently used by commercial processors that manufacture, process, or pack AF and/or LACF. These changes E:\FR\FM\14JAN1.SGM 14JAN1

Agencies

[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2446-2448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00528]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1601]

Custom Device Exemption; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Custom Device
Exemption.'' FDA has developed a draft guidance to provide guidance to
industry and FDA staff about implementation of the custom device
exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act).
The intent of this guidance is to provide draft definitions of 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 what information 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. This draft guidance is
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 17, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Custom Device Exemption'' to the Division
of Small Manufacturers, International, and Consumer Assistance, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-

[[Page 2447]]

8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Erin Keith, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1404, Silver Spring, MD 20993-0002, 301-796-6384,
CustomDevices@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The custom device exemption is set forth at section 520(b)(2)(B) of
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.
Effective on July 9, 2012, 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;
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.
The guidance also provides draft definitions of terms used in the
custom device exemption, explains how FDA plans to interpret the
concept of ``five units per year of a particular device type'' in
section 520(b)(2)(B) of the FD&C Act, describes what information
manufacturers should submit in a custom device annual report (annual
report) to FDA, and provides guidance on how to submit an annual report
for devices distributed under the custom device exemption.
On November 19, 2012, FDA published a Notice of Request for
Comments in the Federal Register (77 FR 69488), requesting stakeholders
to submit information on and examples of appropriate use of the custom
device exemption for assistance in drafting this guidance based on
specific questions asked in the Notice. FDA has reviewed all the
comments from the Notice and has taken them into consideration for this
draft guidance.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the custom
device exemption. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all Center for
Devices and Radiological Health guidance documents is available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov. To receive ``Custom Device Exemption,'' you
may either send an email request to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send a fax request to 301-847-8149
to receive a hard copy. Please use the document number 1820 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (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 before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.

Draft Guidance for Custom Device Exemption

This guidance is intended to assist industry by providing draft
definitions of terms used in the custom device exemption, explains how
FDA proposes to interpret the ``five units per year of a particular
device type'' language contained in section 520(b)(2)(B) of the FD&C
Act, describes what information FDA proposes should be submitted in a
custom device annual report, and provides recommendations on how to
submit an annual report in preparing for annual reports for devices
distributed under the custom device exemption. In addition,
manufacturers of custom devices are required to sign and submit a
Custom Devices Annual Report Truthful and Accurate certificate with
their annual report.
Description of Respondents: The respondents of this collection of
information are manufacturers of medical devices deemed to be custom
devices subject to FDA's laws and regulations. The Agency estimates the
burden of this collection of information as follows:

[[Page 2448]]

Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Guidance title: Custom device exemption Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section VI. Annual Reporting....................................... 33 1 33 40 1,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates it will receive 33 reports for custom devices
annually. The Agency reached this estimate by the number of pre-FDASIA
manufacturers who qualified for custom devices and that percentage of
current manufactures that qualify under post-FDASIA requirements. Only
10 percent of manufacturers would meet this qualification, which was
calculated by adding the number of estimated old custom device
manufactures with the estimated new manufacturers submitting annual
reports of custom devices each year. FDA estimates it will take custom
device manufacturers approximately 40 hours to complete the annual
report described in section VI of the draft guidance. FDA reached this
time estimate based on its expectation of the amount of information
that should be included in the report.
Before the proposed information collection provisions contained in
this draft guidance become effective, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it display a currently valid OMB
control number.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by OMB under the PRA (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 814, subparts B and E
have been approved under OMB control number 0910-0231; the collections
of information in 21 part 812 have been approved under OMB control
number 0910-0078; and the collections of information in 21 part 807,
subpart E have been approved under OMB control number 0910-0120.

V. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

Dated: January 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00528 Filed 1-13-14; 8:45 am]
BILLING CODE 4160-01-P

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