Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals, 54621-54622 [2023-17264]

Download as PDF Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices request or appeal; and FDA’s process for reviewing such requests or appeals. We use the information submitted by respondents to determine whether requests for waiver or reduction of user fees, reconsideration requests, or appeals may be granted. In the Federal Register of April 27, 2023 (88 FR 25658), we published a 60day notice soliciting public comment on the proposed information collection. 54621 One general comment was received encouraging FDA in its mission to promote and protect animal health. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FD&C Act section; activity FDA form No. User fee cover sheets, by type: 740(a)(1); Animal Drug User Fee cover sheet. 741(a)(1); Animal Generic Drug User Fee cover sheet. Waiver and other requests, by type: 740(d)(1)(A); Significant barrier to innovation. 740(d)(1)(B); Fees exceed cost. 740(d)(1)(C); Free choice feeds. 740(d)(1)(D); Minor use or minor species. 740(d)(1)(E); Small business. 741(d)(1); Minor use or minor species. Request for reconsideration of a decision. 21 CFR 10.75; Appeal of a decision. Total ...................... 1 There Total annual responses Average burden per response Total hours 3546 15 1 15 1 ......................................... 15 3728 22 2 44 0.08 (5 minutes) ................. 3.5 N/A 65 1 65 2 ......................................... 130 N/A 8 3.75 30 0.5 (30 minutes) ................. 15 N/A 4 1 4 2 ......................................... 8 N/A 73 1 73 2 ......................................... 146 N/A 1 1 1 2 ......................................... 2 N/A 2 1 2 2 ......................................... 4 N/A 1 1 1 2 ......................................... 2 N/A 1 1 1 2 ......................................... 2 ........................ ........................ ........................ ........................ ............................................. 327.5 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. We attribute this adjustment to an increase in the number of submissions we have received since our last evaluation. The total number of annual responses is based on the average number of submissions received by FDA in fiscal years 2019 to 2021. The estimated time we attribute to the hours per response is based on our experience with the various submissions and reflects the average burden we attribute to all respondents. Dated: August 8, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–17260 Filed 8–10–23; 8:45 am] BILLING CODE 4164–01–P lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondent Number of respondents VerDate Sep<11>2014 16:59 Aug 10, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–1006] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals AGENCY: Food and Drug Administration, HHS. ACTION: FOR FURTHER INFORMATION CONTACT: Notice. The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the collection of information by September 11, 2023. ADDRESSES: To ensure that comments on the information collection are received, SUMMARY: PO 00000 Frm 00057 Fmt 4703 OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0359. Also include the FDA docket number found in brackets in the heading of this document. Sfmt 4703 Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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: E:\FR\FM\11AUN1.SGM 11AUN1 54622 Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices Medical Devices; Reports of Corrections and Removals—21 CFR Part 806 OMB Control Number 0910–0359— Revision This information collection supports implementation of provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(g)) requiring device manufacturers and importers to report promptly to FDA certain actions concerning device corrections and removals and to maintain associated records. Applicable regulations are found in 21 CFR part 806 and set forth definitions, prescribe format and required content elements for reporting, and identify actions that are exempt from the reporting requirements. The information collected is used by FDA to identify marketed devices that have serious problems and to ensure that defective devices are removed from the market. The information also helps ensure that FDA has current and complete information regarding these corrections and removals to determine whether recall action is adequate. Reports of corrections and removals may be submitted to FDA via mail, email, or using FDA’s Electronic Submission Gateway (ESG). To assist respondents with submitting reports of corrections or removals, we developed a fillable PDF electronic submission template entitled, ‘‘Device Correction/ Removal Report for Industry,’’ that transmits required data to FDA’s Recall Enterprise System. Instructions for the fillable template are provided in pop-up text boxes that appear over each data field. We expect that use of the fillable template will expedite processing of the reports of corrections or removals submitted to FDA. In the Federal Register of April 11, 2023 (88 FR 21677), we published a 60day notice soliciting comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of responses per respondent Number of respondents 21 CFR part; collection activity Electronic process setup .................... 806; Submission of corrections and removals ......................................... 4.102(c)(1)(iii); Submitting correction or removal reports (including any sharing of information with other constituent part applicants as required under 4.103) ........................ Total ............................................ Average burden per response Total annual responses Total operating and maintenance costs Total hours 517 1 517 3.08 1,592 $25,850 1,033 1 1,033 10 10,330 .............................. 20 ........................ 1 ........................ 20 ........................ 10 ........................ 200 12,122 .............................. 25,850 For respondents who submit corrections and removals using the ESG, the operating and maintenance costs associated with this information collection are approximately $50 per year to purchase a digital verification certificate (certificate must be valid for 1 to 3 years). This burden may be reduced if the respondent has already purchased a verification certificate for other electronic submissions to FDA. This burden may also be reduced if respondents utilize the new PDF template and submit it to the Agency using email, mitigating the need for a digital verification certificate. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2 Number of recordkeepers 21 CFR part; collection activity 806; Records of corrections and removals .............. 4.105(b); recordkeeping by device-led combination products. Total .................................................................. 1 There Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 93 279 1 1 93 279 10 .............................. 0.5 (30 minutes) ........ 930 140 ........................ ........................ ........................ .................................... 1,070 are no capital costs or operating and maintenance costs associated with this collection of information. have been rounded. lotter on DSK11XQN23PROD with NOTICES1 2 Figures Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate, however we have revised the collection to include the new electronic reporting instrument ‘‘Device Correction/Removal Report for Industry.’’ We estimate that 50 percent of submitters will use the ESG to submit the required information. Our estimate of the reporting and recordkeeping burden is based on Agency records and our experience with this program, as well as similar VerDate Sep<11>2014 16:59 Aug 10, 2023 Jkt 259001 programs that utilize FDA’s ESG. For the purposes of estimating the burden, we assume that all respondents who submit corrections and removals using the electronic process will establish a new WebTrader account and purchase a digital verification certificate. Dated: August 8, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–17264 Filed 8–10–23; 8:45 am] Food and Drug Administration [Docket No. FDA–2018–D–1922] Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability AGENCY: BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration, HHS. Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54621-54622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1006]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Reports of Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the 
collection of information by September 11, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0359. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

[[Page 54622]]

Medical Devices; Reports of Corrections and Removals--21 CFR Part 806

OMB Control Number 0910-0359--Revision

    This information collection supports implementation of provisions 
of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(g)) requiring device manufacturers and importers to report 
promptly to FDA certain actions concerning device corrections and 
removals and to maintain associated records. Applicable regulations are 
found in 21 CFR part 806 and set forth definitions, prescribe format 
and required content elements for reporting, and identify actions that 
are exempt from the reporting requirements. The information collected 
is used by FDA to identify marketed devices that have serious problems 
and to ensure that defective devices are removed from the market. The 
information also helps ensure that FDA has current and complete 
information regarding these corrections and removals to determine 
whether recall action is adequate.
    Reports of corrections and removals may be submitted to FDA via 
mail, email, or using FDA's Electronic Submission Gateway (ESG). To 
assist respondents with submitting reports of corrections or removals, 
we developed a fillable PDF electronic submission template entitled, 
``Device Correction/Removal Report for Industry,'' that transmits 
required data to FDA's Recall Enterprise System. Instructions for the 
fillable template are provided in pop-up text boxes that appear over 
each data field. We expect that use of the fillable template will 
expedite processing of the reports of corrections or removals submitted 
to FDA.
    In the Federal Register of April 11, 2023 (88 FR 21677), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Number of                                                     Total operating
           21 CFR part; collection activity               Number of     responses per   Total annual   Average burden    Total hours    and maintenance
                                                         respondents     respondent       responses     per response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic process setup.............................             517               1             517            3.08           1,592            $25,850
806; Submission of corrections and removals..........           1,033               1           1,033              10          10,330  .................
4.102(c)(1)(iii); Submitting correction or removal                 20               1              20              10             200  .................
 reports (including any sharing of information with
 other constituent part applicants as required under
 4.103)..............................................
    Total............................................  ..............  ..............  ..............  ..............          12,122             25,850
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For respondents who submit corrections and removals using the ESG, 
the operating and maintenance costs associated with this information 
collection are approximately $50 per year to purchase a digital 
verification certificate (certificate must be valid for 1 to 3 years). 
This burden may be reduced if the respondent has already purchased a 
verification certificate for other electronic submissions to FDA. This 
burden may also be reduced if respondents utilize the new PDF template 
and submit it to the Agency using email, mitigating the need for a 
digital verification certificate.

                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
      21 CFR part; collection activity           Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
806; Records of corrections and removals....              93               1              93  10........................................             930
4.105(b); recordkeeping by device-led                    279               1             279  0.5 (30 minutes)..........................             140
 combination products.
    Total...................................  ..............  ..............  ..............  ..........................................           1,070
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Figures have been rounded.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate, however we have revised the collection to include the new 
electronic reporting instrument ``Device Correction/Removal Report for 
Industry.'' We estimate that 50 percent of submitters will use the ESG 
to submit the required information. Our estimate of the reporting and 
recordkeeping burden is based on Agency records and our experience with 
this program, as well as similar programs that utilize FDA's ESG. For 
the purposes of estimating the burden, we assume that all respondents 
who submit corrections and removals using the electronic process will 
establish a new WebTrader account and purchase a digital verification 
certificate.

    Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17264 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
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