Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization, 57443-57444 [2019-23274]

Download as PDF Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices healthcare professional perceptions, beliefs, attitudes, behaviors, and use of drug and biological products and related materials including, but not limited to, social and behavioral research, decisionmaking processes, and communication and behavioral change strategies. Annually, FDA projects about 45 social and behavioral studies using the variety of test methods listed in this document. FDA is requesting this burden so as not to restrict the Agency’s ability to gather information on public sentiment for its proposals in its regulatory and communications programs. In the Federal Register of June 19, 2019 (84 FR 28557), FDA published a 57443 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 respondents Activity Interviews/Surveys ............................. 1 There 5,040 Average burden per response 73,584 Fax written comments on the collection of information by November 25, 2019. 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 0910–0607. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, 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. DATES: Dated: October 16, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23268 Filed 10–24–19; 8:45 am] BILLING CODE 4164–01–P 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; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization Food and Drug Administration, HHS. ACTION: 14.6 Total annual responses 0.25 (15 minutes) .... Total hours 18,396 are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall increase of 9,198 hours and a corresponding increase of 36,792 responses due to an increase in grant funding for universities and others to perform research for FDA. AGENCY: Number of responses per respondent Notice. The Food and Drug Administration (FDA or we) 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: Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization—42 CFR 493.17 OMB Control Number 0910–0607— Extension FDA’s guidance entitled ‘‘Administrative Procedures for CLIA Categorization’’1 describes procedures FDA uses to assign the complexity category to a device, which affects what type of Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate the laboratory obtains. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or premarket approval application (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 June 26, 2019 (84 FR 30127), 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: 1 Available at https://www.fda.gov/media/71065/ download. VerDate Sep<11>2014 18:04 Oct 24, 2019 Jkt 250001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1 57444 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Total operating and maintenance costs Request for CLIA categorization .............. 80 5 400 1 400 $2,000 1 There are no capital costs associated with this collection of information. Based on recent receipt data for requests for CLIA categorization separate from a product application, the number of respondents is approximately 80. On average, each respondent requests such categorizations five times per year. The cost, not including personnel, is estimated at $5 per submission (5 × 400), totaling $2,000. This includes the cost of copying and mailing copies of package inserts and a cover letter. 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). Upon review of this information collection, we have adjusted the estimated cost per submission (previously $52). Because the submissions are typically only a few pages per package insert and copying or printing and postage for a few pages is not expected to be more than $5, we believe this is a more appropriate cost burden estimate. Our estimated burden for the information collection reflects an overall decrease of 500 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. Also, upon review of this information collection, we believe the previous estimate may have included requests for categorization associated with a premarket submission, the burden estimate of which is included under the OMB approval for the applicable premarket submission. We have therefore revised the number of respondents/responses to include only those that are separate from a product application, consistent with the scope of this information collection. Dated: October 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23274 Filed 10–24–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:04 Oct 24, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0190] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) 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: Fax written comments on the collection of information by November 25, 2019. DATES: 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 0910–0671. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. 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 00063 Fmt 4703 Sfmt 4703 Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act OMB Control Number 0910–0671— Extension The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act and providing FDA with the authority to regulate tobacco products (Pub. L. 111–31; 123 Stat. 1776). Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act) (15 U.S.C. 4402), as amended by section 204 of the Tobacco Control Act, requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. Section 3(b)(3)(A) of the Smokeless Tobacco Act requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco ‘‘in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer’’ to, and approved by, FDA. This information collection-the submission to FDA of warning plans for smokeless tobacco products is statutorily mandated. The warning plans will be reviewed by FDA, as required by the Smokeless Tobacco Act, to determine whether the companies’ plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand of smokeless tobacco products comply with section 3 of the Smokeless Tobacco Act, as amended. Additionally, FDA considers a submission to be a supplement if the submitter is seeking approval of a change to an FDA-approved warning plan. Based on FDA’s experience over the past several years, FDA believes the estimate of 60 hours to complete an initial rotational plan continues to be accurate. If a supplement to an approved plan is submitted, FDA E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57443-57444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23274]


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

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; Administrative 
Procedures for Clinical Laboratory Improvement Amendments 
Categorization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 
November 25, 2019.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

Administrative Procedures for Clinical Laboratory Improvement 
Amendments of 1988 Categorization--42 CFR 493.17

OMB Control Number 0910-0607--Extension

    FDA's guidance entitled ``Administrative Procedures for CLIA 
Categorization''\1\ describes procedures FDA uses to assign the 
complexity category to a device, which affects what type of Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) certificate the 
laboratory obtains. Typically, FDA assigns complexity categorizations 
to devices at the time of clearance or approval of the device. In some 
cases, however, a manufacturer may request CLIA categorization even if 
FDA is not simultaneously reviewing a 510(k) or premarket approval 
application (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.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/media/71065/download.
---------------------------------------------------------------------------

    In the Federal Register of June 26, 2019 (84 FR 30127), 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:

[[Page 57444]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                                                        Total operating
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for CLIA categorization...................              80                5              400                1              400           $2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    Based on recent receipt data for requests for CLIA categorization 
separate from a product application, the number of respondents is 
approximately 80. On average, each respondent requests such 
categorizations five times per year.
    The cost, not including personnel, is estimated at $5 per 
submission (5 x 400), totaling $2,000. This includes the cost of 
copying and mailing copies of package inserts and a cover letter. 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). Upon 
review of this information collection, we have adjusted the estimated 
cost per submission (previously $52). Because the submissions are 
typically only a few pages per package insert and copying or printing 
and postage for a few pages is not expected to be more than $5, we 
believe this is a more appropriate cost burden estimate.
    Our estimated burden for the information collection reflects an 
overall decrease of 500 hours. We attribute this adjustment to a 
decrease in the number of submissions we received over the last few 
years. Also, upon review of this information collection, we believe the 
previous estimate may have included requests for categorization 
associated with a premarket submission, the burden estimate of which is 
included under the OMB approval for the applicable premarket 
submission. We have therefore revised the number of respondents/
responses to include only those that are separate from a product 
application, consistent with the scope of this information collection.

    Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23274 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.