83 FR 26694 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Malfunction Summary Reporting Program for Manufacturers
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 111 (June 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26694-26696 | |
| FR Document | 2018-12336 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26694-26696] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12336] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6730] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Malfunction Summary Reporting Program for Manufacturers 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 9, 2018. 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 0910-0437. 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. Medical Device Reporting: Electronic Submission Requirements OMB Control Number 0910-0437--Extension The information collection associated with 21 CFR part 803 is approved under OMB control number 0910-0437. We request revision of the information collection approval as described in this document. In the Federal Register of December 26, 2017 (82 FR 60922), FDA published a notification and request for comments entitled ``Center for Devices and Radiological Health; Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers'' (the notification) which, among other things, proposed a program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form--the Voluntary Malfunction Summary Reporting Program. The proposed program would permit manufacturers of devices in certain product codes to report malfunctions for those devices on a quarterly basis and in a summary format (instead of reporting them as individual, 30-day reports), subject to certain conditions. Therefore, we have added a line item to the reporting burden table in OMB control number 0910-0437, ``Medical Device Reporting: Electronic Submission Requirements,'' for the proposed Voluntary Malfunction Summary Reporting Program. FDA believes that submission of voluntary summary reports in the format described in this document would provide the most compact and efficient reporting mechanism for streamlining malfunction reporting that still provides sufficient detail for FDA to monitor devices effectively. The proposed Voluntary Malfunction Summary Reporting Program is meant to streamline the process of reporting malfunctions. It does not change regulatory requirements for MDR-related investigations or recordkeeping by manufacturers. The proposed program would neither apply to importers or device user facilities, nor affect [[Page 26695]] requirements under part 803 for importers or device user facilities. The proposed program would not apply to reportable death or serious injury events, as described in section III.A of the notification (82 FR 60922 at 60924). In addition, the reporting requirements at Sec. 803.53, which require a 5-day report to be filed at the written request of FDA or if a manufacturer becomes aware of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, would continue to apply to manufacturers participating in the proposed program. The conditions of the proposed Voluntary Summary Malfunction Reporting Program would also require manufacturers to submit individual malfunction reports in certain circumstances (see section III.A of the notification). These factors were considered in determining the revised burden estimates described in table 1. In the Federal Register of December 26, 2017 (82 FR 60922), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment related to the information collection, that stated that the average burden on manufacturers per response of 6 minutes appears to be a very low estimate. FDA disagrees with this comment. The estimation of time is the amount of time needed to submit a summary malfunction report. It is essentially the same amount of time needed to submit an individual report because the event narrative should be the same, with the exception of one additional line that is entered that indicates the number of adverse events represented by the report. It does not include the time needed to investigate the issue. Manufacturers have 120 calendar days from the date they become aware of a reportable malfunction to submit a summary malfunction report that is allowed as part of this voluntary reporting program. For the convenience of the reader, we have noted below the information collection line-items (ICs) that we anticipate would be affected by the Voluntary Malfunction Summary Reporting Program. While the other ICs from OMB control number 0910-0437 are not affected by the Voluntary Malfunction Summary Reporting Program, for consistency and accuracy, we have adjusted the respondent estimates for the ICs using more recent data. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/CFR section FDA Form No. Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Exemptions--803.19 \2\.................................. .............. 85 4 340 1 340 User Facility Reporting--803.30 and 803.32 \2\.......... .............. 520 10.06 5,232 0.35 1,831 User Facility Annual Reporting--803.33 \2\.............. 3419 159 1 159 1 159 Importer Reporting, Death and Serious Injury--803.40 and .............. 578 1 578 1 578 803.42 \2\............................................. Manufacturer Reporting--803.50 through 803.53 \3\....... .............. 1,240 272.50 337,900 0.10 33,790 Voluntary Malfunction Summary Reporting Program \3\..... .............. 1,240 54.47 67,546 0.10 6,755 Supplemental Reports--803.56 \3\........................ .............. 1,050 128.71 135,148 0.10 13,515 ----------------------------------------------------------------------------------------------- Total............................................... .............. .............. .............. .............. .............. 56,968 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information. \2\ This IC has been adjusted based on calendar year (CY) 2016 data; however, there is no program change to this IC. \3\ This IC revises OMB control number 0910-0437 to reflect the Voluntary Malfunction Summary Reporting Program. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden Activity/21 CFR section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- MDR Procedures--803.17 \2\...... 1,240 1 1,240 3.3 4,092 MDR Files--803.18 \2\........... 1,240 1 1,240 1.5 1,860 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 5,952 ---------------------------------------------------------------------------------------------------------------- \1\ There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information. \2\ This IC has been adjusted based on CY 2016 data; however, there is no program change to this IC. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours \3\ respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Importer Reporting, Death and Serious Injury--803.40 and 803.42 \2\ 578 25 14,450 0.35 5,058 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information. \2\ This IC has been adjusted based on CY 2016 data; however, there is no program change to this IC. \3\ Number has been rounded. [[Page 26696]] For consistency and accuracy, we have adjusted the respondent estimates for all the ICs from OMB control number 0910-0437, including those that are not affected by the Voluntary Malfunction Summary Reporting Program, to reflect more recent data from calendar year (CY) 2016 (the currently approved estimates are based on CY 2006-2009 data). This adjustment, along with the revisions for the Voluntary Malfunction Summary Reporting Program increases the estimated total burden of OMB control number 0910-0437 by 21,532 hours (currently approved for 46,446 hours; requesting 67,978 hours). We have added the new burden estimate for the Voluntary Malfunction Summary Reporting Program. This increases the reporting burden estimate by 6,755 hours. We have revised the burden estimates for ``Manufacturer Reporting'' and ``Supplemental Reports'' to update the respondent estimates using more recent data, as described above, and to reflect the revisions resulting from the availability of the Voluntary Malfunction Summary Reporting Program. We believe the availability of the summary reporting option for manufacturers of certain devices would cause a decrease in the number of individual manufacturer reports for malfunctions submitted under Sec. Sec. [thinsp]803.50 and 803.52. However, because we also adjusted the respondent estimates for the ICs using more recent data from CY 2016, the estimated burden for these ICs is an increase of 12,139 hours from the currently approved burden estimates (the previous estimate based on CY 2006-2008 data was 35,166 hours for these ICs only). We attribute the increase to the increase in the number of submissions we received in recent years, rather than the revisions related to the Voluntary Malfunction Summary Reporting Program. Dated: June 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12336 Filed 6-7-18; 8:45 am] BILLING CODE 4164-01-P
![26694 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
submitting the collection to OMB for the mail to policyholders and FOR FURTHER INFORMATION CONTACT:
approval. To comply with this subscribers, which will reduce burden Amber Sanford, Office of Operations,
requirement, CMS is publishing this on issuers. In addition, issuers of Food and Drug Administration, Three
notice. qualified health plans will no longer White Flint North, 10A–12M, 11601
have to submit on the annual report the Landsdown St., North Bethesda, MD
Information Collection
data for the risk corridors program 20852, 301–796–8867, PRAStaff@
1. Type of Information Collection established under section 1342 of the fda.hhs.gov.
Request: Revision of a currently Patient Protection and Affordable Care SUPPLEMENTARY INFORMATION: In
approved collection; Title of Act. Form Number: CMS–10418 (OMB compliance with 44 U.S.C. 3507, FDA
Information Collection: Annual MLR control number: 0938–1164); Frequency: has submitted the following proposed
and Rebate Calculation Report and MLR Annually; Affected Public: Private collection of information to OMB for
Rebate Notices; Use: Under Section Sector, Business or other for-profit and review and clearance.
2718 of the Affordable Care Act and not-for-profit institutions; Number of
implementing regulation at 45 CFR part Respondents: 522; Number of Medical Device Reporting: Electronic
158, a health insurance issuer (issuer) Responses: 2,138; Total Annual Hours: Submission Requirements
offering group or individual health 170,589. (For policy questions regarding OMB Control Number 0910–0437—
insurance coverage must submit a report this collection contact Christina Extension
to the Secretary concerning the amount Whitefield at 301–492–4172.)
the issuer spends each year on claims, The information collection associated
quality improvement expenses, non- Dated: June 5, 2018. with 21 CFR part 803 is approved under
claims costs, Federal and State taxes William N. Parham, III, OMB control number 0910–0437. We
and licensing and regulatory fees, the Director, Paperwork Reduction Staff, Office request revision of the information
amount of earned premium, and of Strategic Operations and Regulatory collection approval as described in this
beginning with the 2014 reporting year, Affairs. document.
the amounts related to the transitional [FR Doc. 2018–12394 Filed 6–7–18; 8:45 am] In the Federal Register of December
reinsurance, risk corridors, and risk BILLING CODE 4120–01–P 26, 2017 (82 FR 60922), FDA published
adjustment programs established under a notification and request for comments
sections 1341, 1342, and 1343, entitled ‘‘Center for Devices and
respectively, of the Affordable Care Act. DEPARTMENT OF HEALTH AND Radiological Health; Medical Devices
An issuer must provide an annual rebate HUMAN SERVICES and Combination Products; Voluntary
if the amount it spends on certain costs Malfunction Summary Reporting
compared to its premium revenue Food and Drug Administration Program for Manufacturers’’ (the
(excluding Federal and States taxes and notification) which, among other things,
licensing and regulatory fees) does not [Docket No. FDA–2017–N–6730] proposed a program for manufacturer
meet a certain ratio, referred to as the reporting of certain device malfunction
medical loss ratio (MLR). Each issuer is Agency Information Collection medical device reports (MDRs) in
required to submit annually MLR data, Activities; Submission for Office of summary form—the Voluntary
including information about any rebates Management and Budget Review; Malfunction Summary Reporting
it must provide, on a form prescribed by Comment Request; Voluntary Program. The proposed program would
CMS, for each State in which the issuer Malfunction Summary Reporting permit manufacturers of devices in
conducts business. Each issuer is also Program for Manufacturers certain product codes to report
required to provide a rebate notice to AGENCY: Food and Drug Administration, malfunctions for those devices on a
each policyholder that is owed a rebate HHS. quarterly basis and in a summary format
and each subscriber of policyholders (instead of reporting them as individual,
ACTION: Notice. 30-day reports), subject to certain
that are owed a rebate for any given
MLR reporting year. Additionally, each SUMMARY: The Food and Drug conditions. Therefore, we have added a
issuer is required to maintain for a Administration (FDA) is announcing line item to the reporting burden table
period of seven years all documents, that a proposed collection of in OMB control number 0910–0437,
records and other evidence that support information has been submitted to the ‘‘Medical Device Reporting: Electronic
the data included in each issuer’s Office of Management and Budget Submission Requirements,’’ for the
annual report to the Secretary. Based (OMB) for review and clearance under proposed Voluntary Malfunction
upon CMS’ experience in the MLR data the Paperwork Reduction Act of 1995. Summary Reporting Program.
collection and evaluation process, CMS FDA believes that submission of
DATES: Fax written comments on the
is updating its annual burden hour voluntary summary reports in the
collection of information by July 9, format described in this document
estimates to reflect the actual numbers
2018. would provide the most compact and
of submissions, rebates and rebate
notices. ADDRESSES: To ensure that comments on efficient reporting mechanism for
The 2017 MLR Reporting Form and the information collection are received, streamlining malfunction reporting that
Instructions reflect changes for the 2017 OMB recommends that written still provides sufficient detail for FDA to
reporting year and beyond. The 2017 comments be faxed to the Office of monitor devices effectively. The
MLR Reporting Form and instructions Information and Regulatory Affairs, proposed Voluntary Malfunction
are also modified to eliminate the OMB, Attn: FDA Desk Officer, Fax: 202– Summary Reporting Program is meant to
amozie on DSK3GDR082PROD with NOTICES1
reporting elements that were required 395–7285, or emailed to oira_ streamline the process of reporting
under the risk corridors data submission submission@omb.eop.gov. All malfunctions. It does not change
requirements in 45 CFR 153.530 for the comments should be identified with the regulatory requirements for MDR-related
2014 through 2016 benefit years. For OMB control number 0910–0437. Also investigations or recordkeeping by
2017, it is expected that issuers will include the FDA docket number found manufacturers. The proposed program
submit fewer reports and on average, in brackets in the heading of this would neither apply to importers or
send fewer notices and rebate checks in document. device user facilities, nor affect
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![26696 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
For consistency and accuracy, we DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
have adjusted the respondent estimates HUMAN SERVICES https://www.regulations.gov. Follow the
for all the ICs from OMB control number instructions for submitting comments.
0910–0437, including those that are not Food and Drug Administration Comments submitted electronically,
affected by the Voluntary Malfunction including attachments, to https://
[Docket No. FDA–2018–N–1881] www.regulations.gov will be posted to
Summary Reporting Program, to reflect
more recent data from calendar year Development of Inhaled Antibacterial the docket unchanged. Because your
(CY) 2016 (the currently approved Drugs for Cystic Fibrosis and Non- comment will be made public, you are
estimates are based on CY 2006–2009 solely responsible for ensuring that your
Cystic Fibrosis Bronchiectasis; Public
comment does not include any
data). This adjustment, along with the Workshop; Request for Comments
confidential information that you or a
revisions for the Voluntary Malfunction
AGENCY: Food and Drug Administration, third party may not wish to be posted,
Summary Reporting Program increases such as medical information, your or
HHS.
the estimated total burden of OMB anyone else’s Social Security number, or
control number 0910–0437 by 21,532 ACTION: Notice of public workshop;
request for comments. confidential business information, such
hours (currently approved for 46,446 as a manufacturing process. Please note
hours; requesting 67,978 hours). SUMMARY: The Food and Drug that if you include your name, contact
We have added the new burden Administration (FDA, the Agency, or information, or other information that
estimate for the Voluntary Malfunction we) is announcing the following public identifies you in the body of your
Summary Reporting Program. This workshop entitled ‘‘Development of comments, that information will be
increases the reporting burden estimate Inhaled Antibacterial Drugs for Cystic posted on https://www.regulations.gov.
by 6,755 hours. Fibrosis and Non-Cystic Fibrosis • If you want to submit a comment
Bronchiectasis.’’ The purpose of the with confidential information that you
We have revised the burden estimates do not wish to be made available to the
public workshop is to discuss the
for ‘‘Manufacturer Reporting’’ and public, submit the comment as a
clinical trial design challenges and
‘‘Supplemental Reports’’ to update the future considerations for inhaled written/paper submission and in the
respondent estimates using more recent antibacterial products to treat cystic manner detailed (see ‘‘Written/Paper
data, as described above, and to reflect fibrosis (CF) and non-CF bronchiectasis. Submissions’’ and ‘‘Instructions’’).
the revisions resulting from the
DATES: The public workshop will be Written/Paper Submissions
availability of the Voluntary held on June 27, 2018, from 8:30 a.m.
Malfunction Summary Reporting Submit written/paper submissions as
to 4:30 p.m. Submit either electronic or follows:
Program. We believe the availability of written comments on this public
the summary reporting option for • Mail/Hand delivery/Courier (for
workshop by July 16, 2018. See the written/paper submissions): Dockets
manufacturers of certain devices would SUPPLEMENTARY INFORMATION section for
cause a decrease in the number of Management Staff (HFA–305), Food and
registration date and information. Drug Administration, 5630 Fishers
individual manufacturer reports for ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852.
malfunctions submitted under be held at FDA’s White Oak Campus, • For written/paper comments
§§ 803.50 and 803.52. However, because 10903 New Hampshire Ave., Building submitted to the Dockets Management
we also adjusted the respondent 31 Conference Center, the Great Room Staff, FDA will post your comment, as
estimates for the ICs using more recent (Rm. 1503), Silver Spring, MD 20993. well as any attachments, except for
data from CY 2016, the estimated Entrance for the public workshop information submitted, marked and
burden for these ICs is an increase of participants (non-FDA employees) is identified, as confidential, if submitted
12,139 hours from the currently through Building 1 where routine as detailed in ‘‘Instructions.’’
approved burden estimates (the security check procedures will be Instructions: All submissions received
previous estimate based on CY 2006– performed. For parking and security must include the Docket No. FDA–
2008 data was 35,166 hours for these ICs information, please refer to https:// 2018–N–1881 for ‘‘Development of
only). We attribute the increase to the www.fda.gov/AboutFDA/ Inhaled Antibacterial Drugs for Cystic
increase in the number of submissions WorkingatFDA/BuildingsandFacilities/ Fibrosis and Non-Cystic Fibrosis
we received in recent years, rather than WhiteOakCampusInformation/ Bronchiectasis.’’ Received comments,
the revisions related to the Voluntary ucm241740.htm. those filed in a timely manner (see
Malfunction Summary Reporting You may submit comments as ADDRESSES), will be placed in the docket
Program. follows. Please note that late, untimely and, except for those submitted as
filed comments will not be considered. ‘‘Confidential Submissions,’’ publicly
Dated: June 4, 2018. Electronic comments must be submitted viewable at https://www.regulations.gov
Leslie Kux, on or before July 16, 2018. The https:// or at the Dockets Management Staff
Associate Commissioner for Policy. www.regulations.gov electronic filing between 9 a.m. and 4 p.m., Monday
[FR Doc. 2018–12336 Filed 6–7–18; 8:45 am] system will accept comments until through Friday.
BILLING CODE 4164–01–P midnight Eastern Time on July 16, 2018. • Confidential Submissions—To
Comments received by mail/hand submit a comment with confidential
delivery/courier (for written/paper information that you do not wish to be
submissions) will be considered timely made publicly available, submit your
amozie on DSK3GDR082PROD with NOTICES1
if they are postmarked or the delivery comments only as a written/paper
service acceptance receipt is on or submission. You should submit two
before that date. copies total. One copy will include the
information you claim to be confidential
Electronic Submissions with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
following way: CONFIDENTIAL INFORMATION.’’ The
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Document Created: 2018-06-08 01:22:03
Document Modified: 2018-06-08 01:22:03
| 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 9, 2018. | |
| 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] | |
| FR Citation | 83 FR 26694 |
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