82 FR 28857 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 121 (June 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 121 (June 26, 2017)
| Page Range | 28857-28858 | |
| FR Document | 2017-13248 |
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)] [Notices] [Pages 28857-28858] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13248] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-4620] 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) 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 July 26, 2017. 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 0910-0359. 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, 10A63, 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. Medical Devices; Reports of Corrections and Removals--21 CFR Part 806 OMB Control Number 0910-0359--Extension FDA is requesting approval for the collection of information regarding reports of corrections and removals required under part 806 (21 CFR part 806), which implements section 519(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105- 115). A description of the information collection requirements are provided as follows: Under Sec. 806.10 (21 CFR 806.10), within 10 working days of initiating any action to correct or remove a device to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act caused by the device that may present a risk to health, device manufacturers or importers must submit a written report to FDA of the correction or removal. Under Sec. 806.20(a), device manufacturers or importers that initiate a correction or removal that is not required to be reported to FDA must keep a record of the correction or removal. The information collected in the reports of corrections and removals will be used by FDA to identify marketed devices that have serious problems and [[Page 28858]] to ensure that defective devices are removed from the market. This will assure that FDA has current and complete information regarding these corrections and removals to determine whether recall action is adequate. Failure to collect this information would prevent FDA from receiving timely information about devices that may have a serious effect on the health of users of the devices. Reports of corrections and removals may be submitted to FDA via mail or using FDA's Electronic Submission Gateway (ESG). We estimate that approximately 99 percent of submitters will use the ESG. 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 respondents who submit corrections and removals using the electronic process, the operating and maintenance costs associated with this information collection are approximately $30 per year to purchase a digital verification certificate (certificate must be valid for 1 to 3 years). This burden may be minimized if the respondent has already purchased a verification certificate for other electronic submissions to FDA. However, FDA is assuming that all respondents who submit corrections and removals using the electronic process will be establishing a new WebTrader account and purchasing a digital verification certificate. We therefore estimate the total operating and maintenance costs to be $30,660 annually (1,022 respondents x $30). In the Federal Register of March 20, 2017 (82 FR 14367), 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average Activity (21 CFR part) Number of responses per Total annual burden per Total hours Total operating and respondents respondent responses response \2\ maintenance costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Electronic process setup \3\....................... 1,022 1 1,022 3.08 3,148 $30,660 Submission of corrections and removals (part 806).. 1,033 1 1,033 10 10,330 ................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. \2\ Totals may not sum due to rounding. \3\ We estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in a total one-time burden of 9,454 hours for the setup of the electronic process. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Activity (21 CFR part) Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Records of corrections and removals (part 806)..................... 93 1 93 10 930 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13248 Filed 6-23-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices 28857
participants and entered into RAPTER; after random assignment. This data Program staff may include coaches, case
and (7) Video recordings of coaching collection activity will be included managers, workshop instructors, job
sessions: Collection of data on the under a separate OMB submission. developers, supervisors, and managers.
interaction between the coaches and Respondents: Program staff and All participants will be able to opt out
participants. individuals enrolled in the Evaluation of participating in the data collection
A second follow-up survey will be of Employment Coaching for TANF and activities.
administered approximately 21 months Other Low-Income Populations.
ANNUAL BURDEN ESTIMATES
Number of
Total Annual Average
responses Annual
Instrument number of number of burden hours
per burden hours
respondents respondents per response
respondent
Baseline data collection—study participants ....................... 6,000 2,000 1 0.33 660
Baseline data collection—staff ............................................. 60 20 100 0.33 660
First follow-up survey ........................................................... 2,400 800 1 1 800
Semi-structured staff interviews ........................................... 66 22 1 1.5 33
Staff survey .......................................................................... 48 16 1 0.75 12
In-depth participant interviews ............................................. 24 8 1 2.5 20
Staff reports of program service receipt .............................. 30 10 5,200 0.03 1,560
Video recordings of coaching sessions ............................... 27 9 10 0.10 9
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND 20852, 301–796–8867, PRAStaff@
Hours: 3,754. HUMAN SERVICES fda.hhs.gov.
In compliance with the requirements SUPPLEMENTARY INFORMATION: In
of section 3506(c)(2)(A) of the Food and Drug Administration
compliance with 44 U.S.C. 3507, FDA
Paperwork Reduction Act of 1995, the has submitted the following proposed
[Docket No. FDA–2016–N–4620]
Administration for Children and collection of information to OMB for
Families is soliciting public comment Agency Information Collection review and clearance.
on the specific aspects of the Activities; Submission for Office of
information collection described above. Management and Budget Review; Medical Devices; Reports of Corrections
Copies of the proposed collection of Comment Request; Medical Devices; and Removals—21 CFR Part 806
information can be obtained and Reports of Corrections and Removals OMB Control Number 0910–0359—
comments may be forwarded by writing Extension
to the Administration for Children and AGENCY: Food and Drug Administration,
Families, Office of Planning, Research, HHS. FDA is requesting approval for the
and Evaluation, 330 C Street SW., ACTION: Notice. collection of information regarding
Washington, DC 20201, Attn: OPRE reports of corrections and removals
Reports Clearance Officer. Email SUMMARY: The Food and Drug required under part 806 (21 CFR part
address: OPREinfocollection@ Administration (FDA) is announcing 806), which implements section 519(g)
acf.hhs.gov. All requests should be that a proposed collection of of the Federal Food, Drug, and Cosmetic
identified by the title of the information information has been submitted to the Act (the FD&C Act) (21 U.S.C. 360i(g)),
collection. Office of Management and Budget as amended by the Food and Drug
The Department specifically requests (OMB) for review and clearance under Modernization Act of 1997 (FDAMA)
comments on (a) whether the proposed the Paperwork Reduction Act of 1995. (Pub. L. 105–115). A description of the
collection of information is necessary DATES: Fax written comments on the information collection requirements are
for the proper performance of the collection of information by July 26, provided as follows:
functions of the agency, including 2017. Under § 806.10 (21 CFR 806.10),
whether the information shall have within 10 working days of initiating any
ADDRESSES: To ensure that comments on action to correct or remove a device to
practical utility; (b) the accuracy of the the information collection are received,
agency’s estimate of the burden of the reduce a risk to health posed by the
OMB recommends that written device or to remedy a violation of the
proposed collection of information; (c) comments be faxed to the Office of
the quality, utility, and clarity of the FD&C Act caused by the device that may
Information and Regulatory Affairs, present a risk to health, device
information to be collected; and (d) OMB, Attn: FDA Desk Officer, FAX:
ways to minimize the burden of the manufacturers or importers must submit
202–395–7285, or emailed to a written report to FDA of the correction
collection of information on oira_submission@omb.eop.gov. All
respondents, including through the use or removal.
comments should be identified with the Under § 806.20(a), device
of automated collection techniques or OMB control number 0910–0359. Also
other forms of information technology. manufacturers or importers that initiate
include the FDA docket number found a correction or removal that is not
sradovich on DSK3GMQ082PROD with NOTICES
Consideration will be given to in brackets in the heading of this
comments and suggestions submitted required to be reported to FDA must
document. keep a record of the correction or
within 60 days of this publication.
FOR FURTHER INFORMATION CONTACT: removal.
Mary Jones, Amber Sanford, Office of Operations, The information collected in the
ACF/OPRE Certifying Officer. Food and Drug Administration, Three reports of corrections and removals will
[FR Doc. 2017–13288 Filed 6–23–17; 8:45 am] White Flint North, 10A63, 11601 be used by FDA to identify marketed
BILLING CODE 4184–09–P Landsdown St., North Bethesda, MD devices that have serious problems and
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![28858 Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
to ensure that defective devices are reporting and recordkeeping burden is respondents who submit corrections
removed from the market. This will based on Agency records and our and removals using the electronic
assure that FDA has current and experience with this program, as well as process will be establishing a new
complete information regarding these similar programs that utilize FDA’s ESG. WebTrader account and purchasing a
corrections and removals to determine For respondents who submit digital verification certificate. We
whether recall action is adequate. corrections and removals using the therefore estimate the total operating
Failure to collect this information electronic process, the operating and and maintenance costs to be $30,660
would prevent FDA from receiving maintenance costs associated with this annually (1,022 respondents × $30).
timely information about devices that information collection are
approximately $30 per year to purchase In the Federal Register of March 20,
may have a serious effect on the health
a digital verification certificate 2017 (82 FR 14367), FDA published a
of users of the devices.
Reports of corrections and removals (certificate must be valid for 1 to 3 60-day notice requesting public
may be submitted to FDA via mail or years). This burden may be minimized comment on the proposed collection of
using FDA’s Electronic Submission if the respondent has already purchased information. No comments were
Gateway (ESG). We estimate that a verification certificate for other received.
approximately 99 percent of submitters electronic submissions to FDA. FDA estimates the burden of this
will use the ESG. Our estimate of the However, FDA is assuming that all collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Activity Number of Total annual Total operating and
responses per burden per Total hours 2
(21 CFR part) respondents responses maintenance costs
respondent response
Electronic process setup 3 ............. 1,022 1 1,022 3.08 3,148 $30,660
Submission of corrections and re-
movals (part 806) ....................... 1,033 1 1,033 10 10,330 ..................................
1 There are no capital costs associated with this collection of information.
2 Totals may not sum due to rounding.
3 We estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual bur-
den hours for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Infor-
mation and Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in
a total one-time burden of 9,454 hours for the setup of the electronic process.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Activity Number of Total annual
records per burden per Total hours
(21 CFR part) recordkeepers records
recordkeeper recordkeeping
Records of corrections and removals (part 806) ................. 93 1 93 10 930
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017. certain information by the Agency. delivery/courier (for written/paper
Anna K. Abram, Under the Paperwork Reduction Act of submissions) will be considered timely
Deputy Commissioner for Policy, Planning, 1995 (PRA), Federal Agencies are if they are postmarked or the delivery
Legislation, and Analysis. required to publish notice in the service acceptance receipt is on or
[FR Doc. 2017–13248 Filed 6–23–17; 8:45 am] Federal Register concerning each before that date.
BILLING CODE 4164–01–P proposed collection of information, Electronic Submissions
including each proposed extension of an
existing collection of information, and Submit electronic comments in the
DEPARTMENT OF HEALTH AND to allow 60 days for public comment in following way.
HUMAN SERVICES response to the notice. This notice • Federal eRulemaking Portal: https://
solicits comments on the reporting www.regulations.gov. Follow the
Food and Drug Administration requirements associated with extralabel instructions for submitting comments.
drug use in animals. Comments submitted electronically,
[Docket No. FDA–2008–N–0312] including attachments, to https://
DATES: Submit either electronic or www.regulations.gov will be posted to
Agency Information Collection written comments on the collection of the docket unchanged. Because your
Activities; Proposed Collection; information by August 25, 2017. comment will be made public, you are
Comment Request; Extralabel Drug
ADDRESSES: You may submit comments solely responsible for ensuring that your
Use in Animals
as follows. Please note that late, comment does not include any
untimely filed comments will not be confidential information that you or a
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Food and Drug Administration,
HHS. considered. Electronic comments must third party may not wish to be posted,
ACTION: Notice. be submitted on or before August 25, such as medical information, your or
2017. The https://www.regulations.gov anyone else’s Social Security number, or
SUMMARY: The Food and Drug electronic filing system will accept confidential business information, such
Administration (FDA or Agency) is comments until midnight Eastern Time as a manufacturing process. Please note
announcing an opportunity for public at the end of August 25, 2017. that if you include your name, contact
comment on the proposed collection of Comments received by mail/hand information, or other information that
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Document Created: 2018-11-14 10:10:41
Document Modified: 2018-11-14 10:10:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by July 26, 2017. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 28857 |
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