Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program, 71109-71110 [2014-28184]

Download as PDF 71109 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices United States that seek an exemption from the labeling requirement of section 403(w)(1) of the FD&C Act. We estimate the burden of this collection of information as follows: TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents FD&C Act Section Average burden per response Total annual responses Total hours 403(w)(6); petition for exemption ......................................... 403(w)(7); notification .......................................................... 5 5 1 1 5 5 100 68 500 340 Total .............................................................................. ........................ ........................ ........................ ........................ 840 asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the number of petitions and notifications received in recent years, we estimate that we will receive an average of five petitions and five notifications annually, over the next 3 years. Assuming an association of one respondent to each petition or notification, we estimate that five respondents will each submit one petition, and five respondents will each submit one notification, as reported in table 2, rows 1 and 2. We base our estimate of the average burdens per response reported in table 2 on our experience with other petition processes. We estimate that a petition would take, on average, 100 hours to develop and submit (Ref. 2). Therefore, we estimate that the burden associated with petitions will be 500 hours annually (5 petitions × 100 hours per petition). The burden of a notification involves collecting documentation that a food ingredient does not pose an allergen risk. Either we can make a determination that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409 of the FD&C Act, or the respondent would submit scientific evidence demonstrating that the ingredient, when manufactured as described, does not contain allergenic protein. We estimate that it would take a respondent 20 hours to prepare and submit a notification based on our determination under a process under section 409 of the FD&C Act that the ingredient does not cause an allergic response. We estimate that it would take a respondent approximately 100 hours to prepare a notification submitting scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein. We have no data on how many notifications would be based on our determination VerDate Sep<11>2014 14:08 Nov 28, 2014 Jkt 235001 that the ingredient does not cause an allergic response or based on scientific evidence that demonstrates that the food ingredient does not contain allergenic protein. Therefore, we estimate that three of the five notifications would be based on scientific evidence, and two of the five notifications would be based on our determination. The average time per notification is then estimated to be 68 hours (2 × 20 hours +3 × 100 hours)/5). Therefore, we estimate that the burden associated with notifications will be 340 hours annually (5 notifications × 68 hours per notification), as reported in table 2. DEPARTMENT OF HEALTH AND HUMAN SERVICES III. References SUMMARY: The following references have been placed on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. RTI International. ‘‘Model to Estimate Costs of Using Labeling as a Risk Reduction Strategy for Consumer Products Regulated by the Food and Drug Administration, Final Report.’’ Prepared for Andrew Stivers, FDA/ CFSAN. Prepared by Muth, M., M. Ball, M. Coglaiti, and S. Karns. RTI Project Number 0211460.005. March, 2011. 2. Gendel, Steven M. ‘‘Food Allergen Petitions and Notifications,’’ Memorandum to File. August 8, 2011. Dated: November 24, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28185 Filed 11–28–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2014–N–0639] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 December 31, 2014. 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0569. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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. E:\FR\FM\01DEN1.SGM 01DEN1 71110 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program (Formerly Requests for Inspection Under the Inspection by Accredited Persons Program)—(OMB Control Number 0910–0569)—Extension Section 201 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) amended section 704 of the Federal Food, Drug, and Cosmetic Act by adding subsection (g) (21 U.S.C. 374(g)). This amendment authorized FDA to establish a voluntary third-party inspection program applicable to manufacturers of class II or class III medical devices who meet certain eligibility criteria. In 2007, the program was modified by the Food and Drug Administration Amendments Act of 2007 by revising eligibility criteria and by no longer requiring prior approval by FDA. To reflect the revisions, FDA modified the title of the collection of information and on March 2, 2009, issued a guidance entitled ‘‘Manufacturer’s Notification of the Intent to Use an Accredited Person Under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007.’’ This guidance supersedes the Agency’s previous guidance regarding requests for third-party inspection and may be found on the Internet at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm085187.htm. This guidance is intended to assist device establishments in determining whether they are eligible to participate in the Accredited Person (AP) Program and, if so, how to submit notification of their intent to use the program. The AP Program applies to manufacturers who currently market their medical devices in the United States and who also market or plan to market their devices in foreign countries. Such manufacturers may need current inspections of their establishments to operate in global commerce. There are approximately 8,000 foreign and 10,000 domestic manufacturers of medical devices. Approximately 5,000 of these firms only manufacture class I devices and are, therefore, not eligible for the AP Program. In addition, 40 percent of the domestic firms do not export devices and therefore are not eligible to participate in the AP Program. Further, 10 to 15 percent of the firms are not eligible due to the results of their previous inspection. FDA estimates there are 4,000 domestic manufacturers and 4,000 foreign manufacturers that are eligible for inclusion under the AP Program. Based on communications with industry, FDA estimates that on an annual basis approximately 20 of these manufacturers may use an AP in any given year. In the Federal Register of May 28, 2014 (79 FR 30619), 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 Activity/21 U.S.C. section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Notification regarding use of an accredited person—374(g) 20 1 20 15 300 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 24, 2014. Leslie Kux, Associate Commissioner for Policy. DATES: [FR Doc. 2014–28184 Filed 11–28–14; 8:45 am] ADDRESSES: Fax written comments on the collection of information by December 31, 2014. 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0332. Also include the FDA docket number found in brackets in the heading of this document. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0619] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices AGENCY: asabaliauskas on DSK5VPTVN1PROD with NOTICES HHS. ACTION: Notice. 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. SUMMARY: VerDate Sep<11>2014 14:08 Nov 28, 2014 Jkt 235001 FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Medical Devices; Humanitarian Use Devices—21 CFR 814 (OMB Control Number 0910–0332)—Extension This collection of information implements the Humanitarian Use Devices (HUD) provision of section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814). Under section 520(m) of the FD&C Act, FDA is authorized to exempt an HUD from the effectiveness requirements of sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is used to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States; (2) would not be available to a person with such a disease or condition unless an exemption is granted because there is no comparable device other than another HUD approved under this exemption that is available to treat or diagnose the disease or condition; and (3) will not expose patients to an unreasonable or significant risk of illness or injury with the probable benefit to health from using the device outweighing the risk of injury or illness from its use. This takes E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Notices]
[Pages 71109-71110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28184]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0639]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Notification of the
Intent To Use an Accredited Person Under the Accredited Persons
Inspection Program

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
December 31, 2014.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0569.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

[[Page 71110]]

Notification of the Intent To Use an Accredited Person Under the
Accredited Persons Inspection Program (Formerly Requests for Inspection
Under the Inspection by Accredited Persons Program)--(OMB Control
Number 0910-0569)--Extension

Section 201 of the Medical Device User Fee and Modernization Act of
2002 (Public Law 107-250) amended section 704 of the Federal Food,
Drug, and Cosmetic Act by adding subsection (g) (21 U.S.C. 374(g)).
This amendment authorized FDA to establish a voluntary third-party
inspection program applicable to manufacturers of class II or class III
medical devices who meet certain eligibility criteria. In 2007, the
program was modified by the Food and Drug Administration Amendments Act
of 2007 by revising eligibility criteria and by no longer requiring
prior approval by FDA. To reflect the revisions, FDA modified the title
of the collection of information and on March 2, 2009, issued a
guidance entitled ``Manufacturer's Notification of the Intent to Use an
Accredited Person Under the Accredited Persons Inspection Program
Authorized by Section 228 of the Food and Drug Administration
Amendments Act of 2007.'' This guidance supersedes the Agency's
previous guidance regarding requests for third-party inspection and may
be found on the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085187.htm. This
guidance is intended to assist device establishments in determining
whether they are eligible to participate in the Accredited Person (AP)
Program and, if so, how to submit notification of their intent to use
the program. The AP Program applies to manufacturers who currently
market their medical devices in the United States and who also market
or plan to market their devices in foreign countries. Such
manufacturers may need current inspections of their establishments to
operate in global commerce.
There are approximately 8,000 foreign and 10,000 domestic
manufacturers of medical devices. Approximately 5,000 of these firms
only manufacture class I devices and are, therefore, not eligible for
the AP Program. In addition, 40 percent of the domestic firms do not
export devices and therefore are not eligible to participate in the AP
Program. Further, 10 to 15 percent of the firms are not eligible due to
the results of their previous inspection. FDA estimates there are 4,000
domestic manufacturers and 4,000 foreign manufacturers that are
eligible for inclusion under the AP Program. Based on communications
with industry, FDA estimates that on an annual basis approximately 20
of these manufacturers may use an AP in any given year.
In the Federal Register of May 28, 2014 (79 FR 30619), 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/21 U.S.C. section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification regarding use of an accredited person--374(g)......... 20 1 20 15 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: November 24, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28184 Filed 11-28-14; 8:45 am]
BILLING CODE 4164-01-P

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