Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization, 7043-7044 [E7-2468]

Download as PDF Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices 7043 TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 801.150(a)(2) 1 There 90 Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2467 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0041] Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization Food and Drug Administration, HHS. ycherry on PROD1PC64 with PRELIMS ACTION: Total Annual Records 20 Hours per Record 1,800 Total Hours 0.5 900 are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s estimate of the reporting burden is based on actual data obtained from industry over the past several years where there are approximately 90 firms subject to this requirement. It is estimated that each of these firms on the average prepares 20 written agreements per year. The recordkeeping requirements of § 801.150(a)(2) consist of making copies and maintaining the actual reporting requests which are required under the reporting section of this collection. AGENCY: Annual Frequency of Recordkeeping Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension for an existing collection of information and to allow 60 days for public commein response to the notice. This notice solicits comments on administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization. VerDate Aug<31>2005 17:27 Feb 13, 2007 Jkt 211001 Submit written or electronic comments on the collection of information by April 16, 2007. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301–827– 1472. SUPPLEMENTARY INFORMATION: Under 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) DATES: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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. Administrative Procedures for CLIA Categorization (42 CFR 493.17) A draft guidance document entitled ‘‘Guidance for Administrative Procedures for CLIA Categorization’’ was released for comment on August 14, 2000. The document describes procedures FDA will use to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer since the labeling (including operating instructions) is included in the 510(k) or PMA. In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g. name change, exempt from 510(k) review). The draft guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available. A previous 60-day notice that published August 14, 2000 (65 FR 49582) announced the availability of a draft guidance and did not include a Paperwork Analysis Section. This 60day notice for public comment supersedes that notice and is correcting that error. FDA estimates the burden of this collection of information as follows: E:\FR\FM\14FEN1.SGM 14FEN1 7044 Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Responses Total Hours Total Operating & Maintenance Costs 42 CFR 493.17 60 15 900 1 hr 900 hr $45,000 Total 60 15 900 1 hr 900 hr $45,000 1 There are no capital costs associated with this collection of information. The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $50. Thisincludes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2468 Filed 2–13–07; 8:45 am] Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2469 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0203] Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ycherry on PROD1PC64 with PRELIMS ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘User Fee Cover Sheet; Form FDA 3397’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. SUPPLEMENTARY INFORMATION: In the Federal Register of August 29, 2006 (71 FR 51195), the agency announced that VerDate Aug<31>2005 17:27 Feb 13, 2007 the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0297. The approval expires on January 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Jkt 211001 [Docket No. 2006N–0432] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-mail to Submit Information to the Center for Veterinary Medicine 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 March 16, 2007. ADDRESSES: To ensure that comments on the information collection are received, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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: Guidance for Industry on How to Use E-mail to Submit Information to the Center for Veterinary Medicine—21 CFR 11.2 (OMB Control Number 0910– 0454)—Extension The Center for Veterinary Medicine (CVM) accepts certain types of submissions electronically with no requirement for a paper copy. These types of documents are listed in public docket 1992S–0251 as required by 21 CFR 11.2. CVM’s ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of the Electronic Records; Electronic Signatures final regulation. CVM’s guidance entitled ‘‘Guidance for Industry #108: How to Submit Information in Electronic Format by E-Mail’’ outlines general standards to be used for the submission of any information by e-mail. In the Federal Register of November 8, 2006 (71 FR 65533), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. The likely respondents for this collection of information are sponsors for new animal drug applications. FDA estimates the burden for this collection of information as follows: E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7043-7044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0041]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Procedures for the Clinical Laboratory 
Improvement Amendments of 1998 Categorization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension for an existing collection of 
information and to allow 60 days for public commein response to the 
notice. This notice solicits comments on administrative procedures for 
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
categorization.

DATES:  Submit written or electronic comments on the collection of 
information by April 16, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-827-1472.

SUPPLEMENTARY INFORMATION: Under 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.

Administrative Procedures for CLIA Categorization (42 CFR 493.17)

    A draft guidance document entitled ``Guidance for Administrative 
Procedures for CLIA Categorization'' was released for comment on August 
14, 2000. The document describes procedures FDA will use to assign the 
complexity category to a device. Typically, FDA assigns complexity 
categorizations to devices at the time of clearance or approval of the 
device. In this way, no additional burden is incurred by the 
manufacturer since the labeling (including operating instructions) is 
included in the 510(k) or PMA. In some cases, however, a manufacturer 
may request CLIA categorization even if FDA is not simultaneously 
reviewing a 510(k) or PMA. One example is when a manufacturer requests 
that FDA assign CLIA categorization to a previously cleared device that 
has changed names since the original CLIA categorization. Another 
example is when a device is exempt from premarket review. In such 
cases, the guidance recommends that manufacturers provide FDA with a 
copy of the package insert for the device and a cover letter indicating 
why the manufacturer is requesting a categorization (e.g. name change, 
exempt from 510(k) review). The draft guidance recommends that in the 
correspondence to FDA the manufacturer should identify the product code 
and classification as well as reference to the original 510(k) when 
this is available.
    A previous 60-day notice that published August 14, 2000 (65 FR 
49582) announced the availability of a draft guidance and did not 
include a Paperwork Analysis Section. This 60-day notice for public 
comment supersedes that notice and is correcting that error.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7044]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               No. of       Annual Frequency     Total Annual        Hours per                         Total Operating &
               CFR Section                   Respondents      per Response        Responses          Responses         Total Hours     Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
42 CFR 493.17                                          60                 15                900               1 hr             900 hr            $45,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                  60                 15                900               1 hr             900 hr            $45,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    The number of respondents is approximately 60. On average, each 
respondent will request categorizations (independent of a 510(k) or 
PMA) 15 times per year. The cost, not including personnel, is estimated 
at $50. Thisincludes the cost of copying and mailing copies of package 
inserts and a cover letter, which includes a statement of the reason 
for the request and reference to the original 510(k) numbers, including 
regulation numbers and product codes.

    Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2468 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S
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