81_FR_61858 81 FR 61685 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization

81 FR 61685 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 173 (September 7, 2016)

Page Range61685-61685
FR Document2016-21352

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 81 Issue 173 (Wednesday, September 7, 2016) 
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Page 61685]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0514]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requests for Clinical 
Laboratory Improvement Amendments Categorization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 October 
7, 2016.

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 0910-0607. 
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, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

Requests for Clinical Laboratory Improvement Amendments of 1988 
Categorization--42 CFR 493.17--OMB Control Number 0910-0607--Extension

    A guidance document entitled ``Guidance for Administrative 
Procedures for CLIA Categorization'' was released on May 7, 2008. The 
document describes procedures FDA uses 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 because the 
labeling (including operating instructions) is included in the 
premarket notification (510(k)) or premarket approval application 
(PMA). In some cases, however, a manufacturer may request Clinical 
Laboratory Improvement Amendments of 1998 (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 
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.
    In the Federal Register of April 27, 2016 (81 FR 24820), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
                        Activity                            respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for CLIA Categorization.........................              60              15             900               1             900         $46,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 $52 per hour (52 x 900), totaling $46,800. This includes 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. The burden hours are based on FDA familiarity with the types of 
documentation typically included in a sponsor's categorization 
requests, and costs for basic office supplies (e.g., paper).

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21352 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61685 Elaine L. Baker, MPH, DLP, comments be faxed to the Office of because the labeling (including Director, Management Analysis and Services Information and Regulatory Affairs, operating instructions) is included in Office, Centers for Disease Control and OMB, Attn: FDA Desk Officer, FAX: the premarket notification (510(k)) or Prevention (CDC). 202–395–7285, or emailed to oira_ premarket approval application (PMA). [FR Doc. 2016–21400 Filed 9–6–16; 8:45 am] submission@omb.eop.gov. All In some cases, however, a manufacturer BILLING CODE 4163–18–P comments should be identified with the may request Clinical Laboratory OMB control number 0910–0607. Also Improvement Amendments of 1998 include the FDA docket number found (CLIA) categorization even if FDA is not DEPARTMENT OF HEALTH AND in brackets in the heading of this simultaneously reviewing a 510(k) or HUMAN SERVICES document. PMA. One example is when a FOR FURTHER INFORMATION CONTACT: FDA manufacturer requests that FDA assign Food and Drug Administration CLIA categorization to a previously PRA Staff, Office of Operations, Food [Docket No. FDA–2013–N–0514] and Drug Administration, Three White cleared device that has changed names Flint North 10A–12M, 11601 since the original CLIA categorization. Agency Information Collection Another example is when a device is Landsdown St., North Bethesda, MD Activities; Submission for Office of exempt from premarket review. In such 20852, PRAStaff@fda.hhs.gov. Management and Budget Review; cases, the guidance recommends that Comment Request; Requests for SUPPLEMENTARY INFORMATION: In manufacturers provide FDA with a copy Clinical Laboratory Improvement compliance with 44 U.S.C. 3507, FDA of the package insert for the device and Amendments Categorization has submitted the following proposed a cover letter indicating why the collection of information to OMB for manufacturer is requesting a AGENCY: Food and Drug Administration, review and clearance. HHS. categorization (e.g. name change, Requests for Clinical Laboratory exempt from 510(k) review). The ACTION: Notice. guidance recommends that in the Improvement Amendments of 1988 SUMMARY: The Food and Drug Categorization—42 CFR 493.17—OMB correspondence to FDA the Administration (FDA) is announcing Control Number 0910–0607—Extension manufacturer should identify the that a proposed collection of product code and classification as well A guidance document entitled information has been submitted to the as reference to the original 510(k) when ‘‘Guidance for Administrative Office of Management and Budget this is available. Procedures for CLIA Categorization’’ (OMB) for review and clearance under was released on May 7, 2008. The In the Federal Register of April 27, the Paperwork Reduction Act of 1995. document describes procedures FDA 2016 (81 FR 24820), FDA published a DATES: Fax written comments on the uses to assign the complexity category 60-day notice requesting public collection of information by October 7, to a device. Typically, FDA assigns comment on the proposed collection of 2016. complexity categorizations to devices at information. No comments were ADDRESSES: To ensure that comments on the time of clearance or approval of the received. the information collection are received, device. In this way, no additional FDA estimates the burden of this OMB recommends that written burden is incurred by the manufacturer collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1 Total operating Number of Average Number of Total annual and Activity responses per burden per Total hours respondents responses maintenance respondent response costs Request for CLIA Categorization ............. 60 15 900 1 900 $46,800 1 There are no capital costs associated with this collection of information. The number of respondents is Dated: August 31, 2016. DEPARTMENT OF HEALTH AND approximately 60. On average, each Leslie Kux, HUMAN SERVICES respondent will request categorizations Associate Commissioner for Policy. (independent of a 510(k) or PMA) 15 Food and Drug Administration [FR Doc. 2016–21352 Filed 9–6–16; 8:45 am] times per year. The cost, not including BILLING CODE 4164–01–P personnel, is estimated at $52 per hour [Docket No. FDA–2013–N–0731] (52 × 900), totaling $46,800. This includes the cost of copying and mailing Agency Information Collection copies of package inserts and a cover Activities; Proposed Collection; letter, which includes a statement of the Comment Request; Human Cells, Tissues, and Cellular and Tissue- reason for the request and reference to Based Products: Establishment the original 510(k) numbers, including mstockstill on DSK3G9T082PROD with NOTICES Registration and Listing; Eligibility regulation numbers and product codes. Determination for Donors; and Current The burden hours are based on FDA Good Tissue Practice familiarity with the types of documentation typically included in a AGENCY: Food and Drug Administration, sponsor’s categorization requests, and HHS. costs for basic office supplies (e.g., ACTION: Notice. paper). VerDate Sep<11>2014 18:44 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1


Document Created: 2016-09-07 11:50:24
Document Modified: 2016-09-07 11:50:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by October 7, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 61685 
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