83 FR 2163 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 10 (January 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 10 (January 16, 2018)
| Page Range | 2163-2165 | |
| FR Document | 2018-00568 |
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)] [Notices] [Pages 2163-2165] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00568] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5569] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking 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 February 15, 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 0910-0442. 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 Devices; Device Tracking--21 CFR Part 821 OMB Control Number 0910-0442--Extension Section 211 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) became effective on February 19, 1998. FDAMA amended the previous medical device tracking provisions under section 519(e)(1) and (2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(e)(1) and (2)) that were added by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the tracking provisions under SMDA, which required tracking of any medical device meeting certain criteria, FDAMA allows FDA discretion in applying tracking provisions to medical devices meeting certain criteria and provides that tracking requirements for medical devices can be imposed only after FDA issues an order. In the Federal Register of February 8, 2002 (67 FR 5943), FDA issued a final rule that conformed existing tracking regulations to changes in tracking provisions effected by FDAMA under part 821 (21 CFR part 821). Section 519(e)(1) of the FD&C Act, as amended by FDAMA, provides that FDA may require by order that a manufacturer adopt a method for tracking a class II or III medical device, if the device meets one of the three following criteria: (1) The failure of the device would be reasonably likely to have serious adverse health consequences, (2) the device is intended to be implanted in the human body for more than 1 year (referred to as a ``tracked implant''), or (3) the device is life- sustaining or life-supporting (referred to as a ``tracked l/s-l/s device'') and is used outside a device user facility. Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information. Manufacturers and FDA (where necessary) use the data to: (1) Expedite the recall of distributed medical devices that are dangerous or defective and (2) facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device. In addition, the regulations include provisions for: (1) Exemptions and variances; (2) system and content requirements for tracking; (3) [[Page 2164]] obligations of persons other than device manufacturers, e.g., distributors; (4) records and inspection requirements; (5) confidentiality; and (6) record retention requirements. Respondents for this collection of information are medical device manufacturers, importers, and distributors of tracked implants or tracked l/s-l/s devices used outside a device user facility. Distributors include multiple and final distributors, including hospitals. The annual hourly burden for respondents involved with medical device tracking is estimated to be 615,380 hours per year. The burden estimates cited in tables 1 through 3 are based on the number of device tracking orders issued in the last 3 years, an average of 12 tracking orders annually. FDA estimates that approximately 22,000 respondents may be subject to tracking reporting requirements. Under Sec. 821.25(a), device manufacturers subject to FDA tracking orders must adopt a tracking method that can provide certain device, patient, and distributor information to FDA within 3 to 10 working days. Assuming one occurrence per year, FDA estimates it would take a firm 20 hours to provide FDA with location data for all tracked devices and 56 hours to identify all patients and/or multiple distributors possessing tracked devices. Under Sec. 821.25(d) manufacturers must notify FDA of distributor noncompliance with reporting requirements. Based on the number of audits manufacturers conduct annually, FDA estimates it would receive no more than one notice in any year, and that it would take 1 hour per incident. Under Sec. 821.30(c)(2), multiple distributors must provide data on current users of tracked devices, current device locations, and other information, upon request from a manufacturer or FDA. FDA has not made such a request and is not aware of any manufacturer making a request. Assuming one multiple distributor receives one request in a year from either a manufacturer or FDA, and that lists may be generated electronically, the Agency estimates a burden of 1 hour to comply. Under Sec. 821.30(d) distributors must verify data or make required records available for auditing, if a manufacturer provides a written request. FDA's estimate of the burden for distributor audit responses assumes that manufacturers audit database entries for 5 percent of tracked devices distributed. Each audited database entry prompts one distributor audit response. Because lists may be generated electronically, FDA estimates a burden of 1 hour to comply. In the Federal Register of October 18, 2017 (82 FR 48516), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited and therefore will not be discussed in this document. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Discontinuation of business-- 1 1 1 1 1 821.1(d)....................... Exemption or variance--821.2 and 1 1 1 1 1 821.30(e)...................... Notification of failure to 1 1 1 1 1 comply--821.25(d).............. Multiple distributor data-- 1 1 1 1 1 821.30(c)(2)................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 4 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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 ---------------------------------------------------------------------------------------------------------------- Tracking information--821.25(a). 12 1 12 76 912 Record of tracking data-- 12 46,260 555,120 1 555,120 821.25(b)...................... Standard operating procedures-- 12 1 12 63 756 821.25(c) \2\.................. Manufacturer data audit-- 12 1,124 13,488 1 13,488 821.25(c)(3)................... Multiple distributor data and 22,000 1 22,000 1 22,000 distributor tracking records-- 821.30(c)(2) and (d)........... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 592,276 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ One-time burden. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of disclosures Total annual Average burden Total hours respondents per respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Acquisition of tracked devices 22,000 1 22,000 1 22,000 and final distributor data-- 821.30(a) and (b).............. Multiple distributor data and 1,100 1 1,100 1 1,100 distributor tracking records-- 821.30(c)(2) and (d)........... ------------------------------------------------------------------------------- [[Page 2165]] Total....................... .............. .............. .............. .............. 23,100 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimate for this information collection has not changed since the last OMB approval. This document also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The collections of information found in Sec. Sec. 821.2(b), 821.25(e), and 821.30(e) have been approved under OMB control number 0910-0191. Dated: January 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00568 Filed 1-12-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2163
Number of re-
Total/annual Average
sponses Annual
Instrument number burden hours
per respond- burden hours
of respondents per response
ent
Extension of Previously Approved Information Collection
6-Month Follow-Up Survey .............................................................................. 766 1 .333 255
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND 1997 (FDAMA) (Pub. L. 105–115)
Hours: 255. HUMAN SERVICES became effective on February 19, 1998.
In compliance with the requirements FDAMA amended the previous medical
Food and Drug Administration device tracking provisions under section
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the [Docket No. FDA–2017–N–5569] 519(e)(1) and (2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
Administration for Children and
Agency Information Collection U.S.C. 360i(e)(1) and (2)) that were
Families is soliciting public comment
Activities; Submission for Office of added by the Safe Medical Devices Act
on the specific aspects of the of 1990 (SMDA) (Pub. L. 101–629).
Management and Budget Review;
information collection described above. Unlike the tracking provisions under
Comment Request; Medical Devices;
Copies of the proposed collection of SMDA, which required tracking of any
Device Tracking
information can be obtained and medical device meeting certain criteria,
comments may be forwarded by writing AGENCY: Food and Drug Administration, FDAMA allows FDA discretion in
to the Administration for Children and HHS. applying tracking provisions to medical
Families, Office of Planning, Research, ACTION: Notice. devices meeting certain criteria and
and Evaluation, 330 C Street SW, provides that tracking requirements for
Washington, DC 20201, Attn: OPRE SUMMARY: The Food and Drug
medical devices can be imposed only
Reports Clearance Officer. Email Administration (FDA) is announcing
after FDA issues an order. In the Federal
that a proposed collection of
address: OPREinfocollection@ Register of February 8, 2002 (67 FR
information has been submitted to the
acf.hhs.gov. All requests should be 5943), FDA issued a final rule that
Office of Management and Budget
identified by the title of the information conformed existing tracking regulations
(OMB) for review and clearance under
collection. to changes in tracking provisions
the Paperwork Reduction Act of 1995.
The Department specifically requests effected by FDAMA under part 821 (21
DATES: Fax written comments on the CFR part 821).
comments on (a) whether the proposed collection of information by February Section 519(e)(1) of the FD&C Act, as
collection of information is necessary 15, 2018. amended by FDAMA, provides that
for the proper performance of the ADDRESSES: To ensure that comments on FDA may require by order that a
functions of the agency, including the information collection are received, manufacturer adopt a method for
whether the information shall have OMB recommends that written tracking a class II or III medical device,
practical utility; (b) the accuracy of the comments be faxed to the Office of if the device meets one of the three
agency’s estimate of the burden of the Information and Regulatory Affairs, following criteria: (1) The failure of the
proposed collection of information; (c) OMB, Attn: FDA Desk Officer, Fax: 202– device would be reasonably likely to
the quality, utility, and clarity of the 395–7285, or emailed to oira_ have serious adverse health
information to be collected; and (d) submission@omb.eop.gov. All consequences, (2) the device is intended
ways to minimize the burden of the comments should be identified with the to be implanted in the human body for
collection of information on OMB control number 0910–0442. Also more than 1 year (referred to as a
respondents, including through the use include the FDA docket number found ‘‘tracked implant’’), or (3) the device is
of automated collection techniques or in brackets in the heading of this life-sustaining or life-supporting
other forms of information technology. document. (referred to as a ‘‘tracked l/s-l/s device’’)
Consideration will be given to FOR FURTHER INFORMATION CONTACT: and is used outside a device user
comments and suggestions submitted Amber Sanford, Office of Operations, facility.
within 60 days of this publication. Food and Drug Administration, Three Tracked device information is
White Flint North, 10A–12M, 11601 collected to facilitate identifying the
Mary Jones, current location of medical devices and
Landsdown St., North Bethesda, MD
ACF/OPRE Certifying Officer. 20852, 301–796–8867, PRAStaff@ patients possessing those devices, to the
[FR Doc. 2018–00612 Filed 1–12–18; 8:45 am] fda.hhs.gov. extent that patients permit the
BILLING CODE 4184–09–P collection of identifying information.
SUPPLEMENTARY INFORMATION: In Manufacturers and FDA (where
compliance with 44 U.S.C. 3507, FDA necessary) use the data to: (1) Expedite
has submitted the following proposed the recall of distributed medical devices
collection of information to OMB for that are dangerous or defective and (2)
review and clearance. facilitate the timely notification of
daltland on DSKBBV9HB2PROD with NOTICES
Medical Devices; Device Tracking—21 patients or licensed practitioners of the
CFR Part 821 risks associated with the medical
device.
OMB Control Number 0910–0442— In addition, the regulations include
Extension provisions for: (1) Exemptions and
Section 211 of the Food and Drug variances; (2) system and content
Administration Modernization Act of requirements for tracking; (3)
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![Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2165
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
Total .............................................................................. ........................ ........................ ........................ ........................ 23,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this assessment of medical devices and to anyone else’s Social Security number, or
information collection has not changed improve consistency and predictability confidential business information, such
since the last OMB approval. in the premarket review process where as a manufacturing process. Please note
This document also refers to certain FDA recognized standards are that if you include your name, contact
previously approved collections of used. information, or other information that
information found in FDA regulations. DATES: The public workshop will be identifies you in the body of your
These collections of information are held on May 22 and 23, 2018, from 9 comments, that information will be
subject to review by OMB under the a.m. to 5 p.m. Submit either electronic posted on https://www.regulations.gov.
PRA (44 U.S.C. 3501–3520). The or written comments on this public • If you want to submit a comment
collections of information found in workshop by June 29, 2018. See the with confidential information that you
§§ 821.2(b), 821.25(e), and 821.30(e) SUPPLEMENTARY INFORMATION section for do not wish to be made available to the
have been approved under OMB control registration date and information. public, submit the comment as a
number 0910–0191. ADDRESSES: The public workshop will written/paper submission and in the
Dated: January 9, 2018. be held at FDA’s White Oak Campus, manner detailed (see ‘‘Written/Paper
Leslie Kux, 10903 New Hampshire Ave., Bldg. 31 Submissions’’ and ‘‘Instructions’’).
Associate Commissioner for Policy. Conference Center, the Great Room (Rm. Written/Paper Submissions
[FR Doc. 2018–00568 Filed 1–12–18; 8:45 am] 1503), Silver Spring, MD 20993.
Entrance for the public workshop Submit written/paper submissions as
BILLING CODE 4164–01–P
participants (non-FDA employees) is follows:
through Building 1 where routine • Mail/Hand delivery/Courier (for
security check procedures will be written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND Management Staff (HFA–305), Food and
HUMAN SERVICES performed. For parking and security
information, please refer to https:// Drug Administration, 5630 Fishers
Food and Drug Administration www.fda.gov/AboutFDA/ Lane, Rm. 1061, Rockville, MD 20852.
WorkingatFDA/BuildingsandFacilities/ • For written/paper comments
[Docket No. FDA–2017–N–6877] submitted to the Dockets Management
WhiteOakCampusInformation/
ucm241740.htm. Staff, FDA will post your comment, as
Accreditation Scheme for Conformity well as any attachments, except for
Assessment of Medical Devices to You may submit comments as
follows. Please note that late, untimely information submitted, marked and
Food and Drug Administration- identified, as confidential, if submitted
Recognized Standards; Public filed comments will not be considered.
Electronic comments must be submitted as detailed in ‘‘Instructions.’’
Workshop; Request for Comments Instructions: All submissions received
on or before June 29, 2018. The https://
AGENCY: Food and Drug Administration, www.regulations.gov electronic filing must include the Docket No. FDA–
HHS. system will accept comments until 2017–N–6877 for ‘‘Accreditation
ACTION: Notice of public workshop; midnight Eastern Time at the end of Scheme for Conformity Assessment of
request for comments. June 29, 2018. Comments received by Medical Devices to FDA-Recognized
mail/hand delivery/courier (for written/ Standards; Public Workshop; Request
SUMMARY: The Food and Drug paper submissions) will be considered for Comments.’’ Received comments,
Administration (FDA, the Agency, or timely if they are postmarked or the those filed in a timely manner (see
we) is announcing the following public delivery service acceptance receipt is on ADDRESSES), will be placed in the docket
workshop entitled ‘‘Accreditation or before that date. and, except for those submitted as
Scheme for Conformity Assessment of ‘‘Confidential Submissions,’’ publicly
Medical Devices to FDA-Recognized Electronic Submissions viewable at https://www.regulations.gov
Standards.’’ The purpose of the Submit electronic comments in the or at the Dockets Management Staff
workshop is to present a draft design of following way: between 9 a.m. and 4 p.m., Monday
the Accreditation Scheme for • Federal eRulemaking Portal: through Friday.
Conformity Assessment (ASCA) pilot https://www.regulations.gov. Follow the • Confidential Submissions—To
program. The workshop is intended to instructions for submitting comments. submit a comment with confidential
discuss and obtain input and Comments submitted electronically, information that you do not wish to be
recommendations from stakeholders on including attachments, to https:// made publicly available, submit your
the draft accreditation scheme, www.regulations.gov will be posted to comments only as a written/paper
daltland on DSKBBV9HB2PROD with NOTICES
including its goals and scope, a suitable the docket unchanged. Because your submission. You should submit two
framework and procedures, and comment will be made public, you are copies total. One copy will include the
requirements to facilitate solely responsible for ensuring that your information you claim to be confidential
implementation of an eventual pilot comment does not include any with a heading or cover note that states
program. The overarching objectives of confidential information that you or a ‘‘THIS DOCUMENT CONTAINS
the ASCA pilot program are to third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The
streamline the standards conformity such as medical information, your or Agency will review this copy, including
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Document Created: 2018-01-13 02:02:42
Document Modified: 2018-01-13 02:02:42
| 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 February 15, 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 2163 |
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