Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification, 48696-48697 [2010-19746]

Download as PDF 48696 Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices firms 4 hours per review each quarter, the total burden of this activity, for firms that choose to review their plans annually, is 2,320 (145 x 4 x 4) hours per year. This annual burden is shown in row 6 of table 1 of this document. Dated: August 5, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: ORR Requirements for Refugee Cash Assistance; and Refugee Medical Assistance (45 CFR Part 400). OMB No.: 0970–0036. Description: As required by section 412(e) of the Immigration and Nationality Act, the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is requesting the information from Form ORR–6 to determine the effectiveness of [FR Doc. 2010–19747 Filed 8–10–10; 8:45 am] BILLING CODE 4160–01–S the State cash and medical assistance, child welfare, social services, and targeted assistance programs. State-byState Refugee Cash Assistance (RCA) and Refugee Medical Assistance (RMA) utilization rates derived from Form ORR–6 are calculated for use in formulating program initiatives, priorities, standards, budget requests, and assistance policies. ORR regulations require that State Refugee Resettlement and Wilson-Fish agencies, and local and Tribal governments complete Form ORR–6 in order to participate in the above-mentioned programs. Respondents: State Refugee Resettlement and Wilson-Fish Agencies, local, and Tribal governments. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ORR–6 ............................................................................................................. sroberts on DSKD5P82C1PROD with NOTICES Instrument 50 3 3.88 582 Estimated Total Annual Burden Hours: 582. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project. Fax: 202–395–7285. Email: OIRA_SUBMISSION@OMB.EOP.GOV. Attn: Desk Officer for the Administration for Children and Families. Dated: August 5, 2010. Robert Sargis, Reports Clearance Officer. [FR Doc. 2010–19748 Filed 8–10–10; 8:45 am] BILLING CODE 4184–01–P VerDate Mar<15>2010 18:34 Aug 10, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0198] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification 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 September 10, 2010. 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0120. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@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. Premarket Notification—(OMB Control Number 0910–0120)—Extension Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) and the implementing regulation under part 807 (21 CFR part 807, subpart E) requires a person who intends to market a medical device to submit a premarket notification submission to FDA at least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. Based on the information provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device, as defined in § 807.92(a)(3). If the device is determined to be not substantially equivalent to a legally marketed device, it must have an approved premarket approval application (PMA), Product Development Protocol, Humanitarian Device Exemption (HDE), Petition for Evaluation of Automatic Class III Designation (de novo) or be reclassified E:\FR\FM\11AUN1.SGM 11AUN1 Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices into class I or class II before being marketed. FDA makes the final decision of whether a device is substantially equivalent or not equivalent. Section 807.81 states when a premarket notification is required. A premarket notification is required to be submitted by a person who is: • Introducing a device to the market for the first time; • Introducing a device into commercial distribution for the first time by a person who is required to register; and • Introducing or reintroducing a device which is significantly changed or modified in design, components, method of manufacturer, or the intended use that could affect the safety and effectiveness of the device. Section 807.87 specifies information required in a premarket notification submission. Section 204 of the Food and Drug Administration Modernization Act (FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions including premarket notifications or other requirements. FDA has published and updated the list of recognized standards regularly since enactment of FDAMA 48697 available within 30 days of a request, all information included in the submitted premarket notification on safety and effectiveness. This information will be provided to any person within 30 days of a request if the device described in the 510(k) submission is determined to be substantially equivalent. The information provided will be a duplicate of the 510(k) submission including any safety and effectiveness information, but excluding all patient identifiers and trade secret and commercial confidential information. According to § 807.90, submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, Form FDA 3541, and fax it to the Center for Devices and Radiological Health office identified on the form. The most likely respondents to this information collection will be specification developers and medical device manufacturers. In the Federal Register of May 5, 2010 (75 FR 24708), 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: and has allowed 510(k) submitters to certify conformance to recognized standards to meet the requirements of § 807.87. FDA Form FDA 3654, the 510(k) Standards Data Form, standardizes the format for submitting information on consensus standards that a 510(k) submitter chooses to use as a portion of their premarket notification submission (The Form FDA 3654 is not for declarations of conformance to a recognized standard). FDA believes that use of this form will simplify the 510(k) preparation and review process for 510(k). Form FDA 3514, a summary coversheet form, assists respondents in categorizing administrative 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs such as PMAs, investigational device exemptions, and HDEs. Under § 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) as required by § 807.92 (510(k) summary) or a statement certifying that the submitter will make available upon request the information in the 510(k) with certain exceptions as per § 807.93 (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the 510(k) submission, § 807.93 requires that the official correspondent of the firm make TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Form Number No. of Respondents 807 subpart E Annual Frequency per Response Total Annual Responses 3,800 1 Hours per Response 3,800 Total Hours 79 300,200 807.87 FDA Form 3514 1,956 1 1,956 807.90 (a)(3) FDA Form 3541 218 1 218 807.87(d) and (f) FDA Form 3654 1,500 1 1,500 10 15,000 2,000 10 2,000 10 20,000 807.92 and 807.93 0.5 0.25 Total sroberts on DSKD5P82C1PROD with NOTICES 1 There 978 55 336,233 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 5, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–19746 Filed 8–10–10; 8:45 am] BILLING CODE 4160–01–S VerDate Mar<15>2010 16:52 Aug 10, 2010 Jkt 220001 PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48696-48697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19746]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0198]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Premarket 
Notification

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 
September 10, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0120. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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.

Premarket Notification--(OMB Control Number 0910-0120)--Extension

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(k)) and the implementing regulation under part 807 
(21 CFR part 807, subpart E) requires a person who intends to market a 
medical device to submit a premarket notification submission to FDA at 
least 90 days before proposing to begin the introduction, or delivery 
for introduction into interstate commerce, for commercial distribution 
of a device intended for human use. Based on the information provided 
in the notification, FDA must determine whether the new device is 
substantially equivalent to a legally marketed device, as defined in 
Sec.  807.92(a)(3). If the device is determined to be not substantially 
equivalent to a legally marketed device, it must have an approved 
premarket approval application (PMA), Product Development Protocol, 
Humanitarian Device Exemption (HDE), Petition for Evaluation of 
Automatic Class III Designation (de novo) or be reclassified

[[Page 48697]]

into class I or class II before being marketed. FDA makes the final 
decision of whether a device is substantially equivalent or not 
equivalent.
    Section 807.81 states when a premarket notification is required. A 
premarket notification is required to be submitted by a person who is:
     Introducing a device to the market for the first time;
     Introducing a device into commercial distribution for the 
first time by a person who is required to register; and
     Introducing or reintroducing a device which is 
significantly changed or modified in design, components, method of 
manufacturer, or the intended use that could affect the safety and 
effectiveness of the device.
    Section 807.87 specifies information required in a premarket 
notification submission.
    Section 204 of the Food and Drug Administration Modernization Act 
(FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions including premarket 
notifications or other requirements. FDA has published and updated the 
list of recognized standards regularly since enactment of FDAMA and has 
allowed 510(k) submitters to certify conformance to recognized 
standards to meet the requirements of Sec.  807.87. FDA Form FDA 3654, 
the 510(k) Standards Data Form, standardizes the format for submitting 
information on consensus standards that a 510(k) submitter chooses to 
use as a portion of their premarket notification submission (The Form 
FDA 3654 is not for declarations of conformance to a recognized 
standard). FDA believes that use of this form will simplify the 510(k) 
preparation and review process for 510(k).
    Form FDA 3514, a summary coversheet form, assists respondents in 
categorizing administrative 510(k) information for submission to FDA. 
This form also assists respondents in categorizing information for 
other FDA medical device programs such as PMAs, investigational device 
exemptions, and HDEs. Under Sec.  807.87(h), each 510(k) submitter must 
include in the 510(k) either a summary of the information in the 510(k) 
as required by Sec.  807.92 (510(k) summary) or a statement certifying 
that the submitter will make available upon request the information in 
the 510(k) with certain exceptions as per Sec.  807.93 (510(k) 
statement). If the 510(k) submitter includes a 510(k) statement in the 
510(k) submission, Sec.  807.93 requires that the official 
correspondent of the firm make available within 30 days of a request, 
all information included in the submitted premarket notification on 
safety and effectiveness. This information will be provided to any 
person within 30 days of a request if the device described in the 
510(k) submission is determined to be substantially equivalent. The 
information provided will be a duplicate of the 510(k) submission 
including any safety and effectiveness information, but excluding all 
patient identifiers and trade secret and commercial confidential 
information. According to Sec.  807.90, submitters may request 
information on their 510(k) review status 90 days after the initial 
log-in date of the 510(k). Thereafter, the submitter may request status 
reports every 30 days following the initial status request. To obtain a 
510(k) status report, the submitter should complete the status request 
form, Form FDA 3541, and fax it to the Center for Devices and 
Radiological Health office identified on the form. The most likely 
respondents to this information collection will be specification 
developers and medical device manufacturers.
    In the Federal Register of May 5, 2010 (75 FR 24708), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of         Annual Frequency      Total Annual          Hours per
         21 CFR  Section             Form  Number         Respondents        per Response          Responses           Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807 subpart E                     ..................               3,800                   1               3,800               79                300,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87                                 FDA Form 3514               1,956                   1               1,956                0.5                  978
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.90 (a)(3)                          FDA Form 3541                 218                   1                 218                0.25                  55
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87(d) and (f)                      FDA Form 3654               1,500                   1               1,500               10                 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.92 and 807.93                 ..................               2,000                  10               2,000               10                 20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                            336,233
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19746 Filed 8-10-10; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.