83 FR 62583 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 233 (December 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 233 (December 4, 2018)
| Page Range | 62583-62585 | |
| FR Document | 2018-26303 |
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)] [Notices] [Pages 62583-62585] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26303] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3815] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with electronic submission of medical device registration and listing. DATES: Submit either electronic or written comments on the collection of information by February 4, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 4, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-N-3815 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly [[Page 62584]] available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Electronic Submission of Medical Device Registration and Listing--21 CFR Part 807, Subparts A Through D OMB Control Number 0910-0625--Extension Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners and operators are required to electronically submit establishment registration and device listing information. Complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives, such as: (1) Identification of establishments producing marketed medical devices, (2) identification of establishments producing a specific device when that device is in short supply or is needed for national emergency, (3) facilitation of recalls for devices marketed by owners and operators of device establishments, (4) identification and cataloguing of marketed devices, (5) administering postmarketing surveillance programs for devices, (6) identification of devices marketed in violation of the law, (7) identification and control of devices imported into the country from foreign establishments, (8) and scheduling and planning inspections of registered establishments under section 704 of the FD&C Act (21 U.S.C. 374). Respondents to this information collection are owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices, who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements. The number of respondents is based on data from the FDA Unified Registration and Listing System. Burden estimates are based on recent experience with the existing medical device registration and listing program, electronic system operating experience, and previous data estimates. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Annual 21 CFR section FDA form No. Number of frequency per Total annual Hours per Total hours respondents response responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- 807.20(a)(5) \2\--Submittal of Manufacturer Information 3673 5,736 1 5,736 1.75 10,038 by Initial Importers................................... 807.20(a)(5) \3\--Submittal of Manufacturer Information 3673 5,736 1 5,736 0.1 574 by Initial Importers................................... 807.21(a) \2\--Creation of Electronic System Account.... 3673 2,937 1 2,937 0.5 1,469 807.21(b) \3\--Annual Request for Waiver from Electronic .............. 1 1 1 1 1 Registration and Listing............................... 807.21(b) \2\--Initial Request for Waiver from .............. 1 1 1 1 1 Electronic Registration and Listing for................ 807.22(a) \2\--Initial Registration and Listing......... 3673 3,467 1 3,467 1 3,467 807.22(b)(1) \3\--Annual Registration................... 3673 23,403 1 23,403 0.5 11,702 [[Page 62585]] 807.22(b)(2) \3\--Other Updates of Registration......... 3673 2,687 1 2,687 0.5 1,344 807.22(b)(3) \3\--Annual Update of Listing Information.. 3673 22,607 1 22,607 0.5 11,304 807.26(e) \3\--Labeling and Advertisement Submitted at .............. 71 1 71 1 71 FDA Request............................................ 807.34(a) \2\--Initial Registration and Listing when .............. 1 1 1 1 1 Electronic Filing Waiver Granted....................... 807.34(a) \3\--Annual Registration and Listing when .............. 1 1 1 1 1 Electronic Filing Waiver Granted....................... 807.40(b)(2) \3\--Annual Update of US Agent Information. 3673 1,615 1 1,615 0.5 808 807.40(b)(3) \3\--US Agent Responses to FDA Requests for 3673 1,535 1 1,535 0.25 384 Information............................................ 807.41(a) \3\--Identification of Initial Importers by 3673 12,983 1 12,983 0.5 6,492 Foreign Establishments................................. 807.41(b) \3\--Identification of Other Parties that 3673 12,983 1 12,983 0.5 6,492 Facilitate Import by Foreign Establishments............ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total One Time Burden............................... .............. .............. .............. .............. .............. 14,975 -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Recurring Burden.......................... .............. .............. .............. .............. .............. 39,173 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Totals are rounded to the nearest whole number. \2\ One-Time Burden--Firm only provides initially. \3\ Recurring Burden--Firm is required to review annually. Table 2--Estimated Annual Recordkeeping Burden\1\ ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR section Number of frequency per Total annual Hours per Total hours respondents recordkeeper records record ---------------------------------------------------------------------------------------------------------------- 807.25(d) \2\--List of Officers, 22,338 1 22,338 .25 5,585 Directors, and Partners........ (15 minutes) 807.26 \2\--Labeling and 17,032 4 68,128 .5 34,064 Advertisements Available for (30 minutes) Review......................... ---------------------------------------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 39,649 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Recurring burden--Firm is required to keep records. The following adjustments and program changes resulted in a 5,672- hour decrease to the overall total hour burden estimate for this information collection request. We adjusted the number of respondents based on updated registration and listing data. In the reporting burden table, we corrected the table footnotes to accurately indicate whether the information collection (IC) is a one-time or reoccurring burden. We also adjusted some of the IC descriptions in the table for increased clarity. We updated our estimate of Hours per Response for ``807.22(a) Initial Registration and Listing'' (+ 0.5 hours), ``807.22(b)(1) Annual Registration'' (- 0.25 hours), and ``807.22(b)(3) Annual Update of Listing Information'' (- 0.25 hours). Based on our review of the program, we believe these changes to the burden estimate will more accurately reflect the current preparation time for these ICs. Dated: November 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26303 Filed 12-3-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62583
the development of drugs for this DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
indication. This draft guidance does not HUMAN SERVICES confidential business information, such
address the clinical development of as a manufacturing process. Please note
drugs for the treatment of cirrhosis Food and Drug Administration that if you include your name, contact
caused by NASH. [Docket No. FDA–2015–N–3815] information, or other information that
identifies you in the body of your
This draft guidance is being issued
Agency Information Collection comments, that information will be
consistent with FDA’s good guidance posted on https://www.regulations.gov.
Activities; Proposed Collection;
practices regulation (21 CFR 10.115). • If you want to submit a comment
Comment Request; Electronic
The draft guidance, when finalized, will with confidential information that you
Submission of Medical Device
represent the current thinking of FDA Registration and Listing do not wish to be made available to the
on ‘‘Non-Cirrhotic Nonalcoholic public, submit the comment as a
Steatohepatitis with Liver Fibrosis: AGENCY: Food and Drug Administration, written/paper submission and in the
Developing Drugs for Treatment.’’ It HHS. manner detailed (see ‘‘Written/Paper
does not establish any rights for any ACTION: Notice. Submissions’’ and ‘‘Instructions’’).
person and is not binding on FDA or the Written/Paper Submissions
SUMMARY: The Food and Drug
public. You can use an alternative Administration (FDA or Agency) is
approach if it satisfies the requirements Submit written/paper submissions as
announcing an opportunity for public follows:
of the applicable statutes and comment on the proposed collection of • Mail/Hand delivery/Courier (for
regulations. This guidance is not subject certain information by the Agency. written/paper submissions): Dockets
to Executive Order 12866. Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
II. Paperwork Reduction Act of 1995 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
This draft guidance refers to Federal Register concerning each • For written/paper comments
previously approved collections of proposed collection of information, submitted to the Dockets Management
information found in FDA regulations. including each proposed extension of an Staff, FDA will post your comment, as
These collections of information are existing collection of information, and well as any attachments, except for
subject to review by the Office of to allow 60 days for public comment in information submitted, marked and
Management and Budget (OMB) under response to the notice. This notice identified, as confidential, if submitted
the Paperwork Reduction Act of 1995 solicits comments on information as detailed in ‘‘Instructions.’’
(44 U.S.C. 3501–3520). The collections collection associated with electronic Instructions: All submissions received
of information in 21 CFR part 312 submission of medical device must include the Docket No. FDA–
registration and listing. 2015–N–3815 for ‘‘Agency Information
addressing investigational new drug
DATES: Submit either electronic or Collection Activities; Proposed
applications and 21 CFR part 314
written comments on the collection of Collection; Comment Request;
addressing new drug applications have
information by February 4, 2019. Electronic Submission of Medical
been approved under OMB control Device Registration and Listing.’’
ADDRESSES: You may submit comments
numbers 0910–0014 and 0910–0001, Received comments, those filed in a
respectively. The collections of as follows. Please note that late,
untimely filed comments will not be timely manner (see ADDRESSES), will be
information in 21 CFR parts 50 and 56 placed in the docket and, except for
considered. Electronic comments must
(Protection of Human Subjects: those submitted as ‘‘Confidential
be submitted on or before February 4,
Informed Consent; Institutional Review 2019. The https://www.regulations.gov Submissions,’’ publicly viewable at
Boards) have been approved under OMB electronic filing system will accept https://www.regulations.gov or at the
control number 0910–0755. comments until 11:59 p.m. Eastern Time Dockets Management Staff between 9
III. Electronic Access at the end of February 4, 2019. a.m. and 4 p.m., Monday through
Comments received by mail/hand Friday.
Persons with access to the internet delivery/courier (for written/paper • Confidential Submissions—To
may obtain the draft guidance at either submissions) will be considered timely submit a comment with confidential
https://www.fda.gov/Drugs/ if they are postmarked or the delivery information that you do not wish to be
GuidanceComplianceRegulatory service acceptance receipt is on or made publicly available, submit your
Information/Guidances/default.htm or before that date. comments only as a written/paper
https://www.regulations.gov. submission. You should submit two
Electronic Submissions copies total. One copy will include the
Dated: November 29, 2018. Submit electronic comments in the information you claim to be confidential
Leslie Kux, following way: with a heading or cover note that states
Associate Commissioner for Policy. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2018–26333 Filed 12–3–18; 8:45 am] https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
instructions for submitting comments. Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
such as medical information, your or contact information to be made publicly
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![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62585
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Annual
Number of Total annual Hours per
21 CFR section FDA form No. frequency Total hours
respondents responses response
per response
807.22(b)(2) 3—Other Updates of Reg-
istration ................................................. 3673 2,687 1 2,687 0.5 1,344
807.22(b)(3) 3—Annual Update of Listing
Information ............................................ 3673 22,607 1 22,607 0.5 11,304
807.26(e) 3—Labeling and Advertisement
Submitted at FDA Request .................. ........................ 71 1 71 1 71
807.34(a) 2—Initial Registration and List-
ing when Electronic Filing Waiver
Granted ................................................. ........................ 1 1 1 1 1
807.34(a) 3—Annual Registration and
Listing when Electronic Filing Waiver
Granted ................................................. ........................ 1 1 1 1 1
807.40(b)(2) 3—Annual Update of US
Agent Information ................................. 3673 1,615 1 1,615 0.5 808
807.40(b)(3) 3—US Agent Responses to
FDA Requests for Information ............. 3673 1,535 1 1,535 0.25 384
807.41(a) 3—Identification of Initial Im-
porters by Foreign Establishments ...... 3673 12,983 1 12,983 0.5 6,492
807.41(b) 3—Identification of Other Par-
ties that Facilitate Import by Foreign
Establishments ..................................... 3673 12,983 1 12,983 0.5 6,492
Total One Time Burden .................... ........................ ........................ ........................ ........................ ........................ 14,975
Total Recurring Burden ............. ........................ ........................ ........................ ........................ ........................ 39,173
1 Totals are rounded to the nearest whole number.
2 One-Time Burden—Firm only provides initially.
3 Recurring Burden—Firm is required to review annually.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual
Number of Total annual Hours per
21 CFR section frequency per Total hours
respondents records record
recordkeeper
807.25(d) 2—List of Officers, Directors, and Partners ......... 22,338 1 22,338 .25 5,585
(15 minutes)
807.26 2—Labeling and Advertisements Available for Re-
view .................................................................................. 17,032 4 68,128 .5 34,064
(30 minutes)
Total .............................................................................. ........................ ........................ ........................ ........................ 39,649
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recurring burden—Firm is required to keep records.
The following adjustments and Annual Update of Listing Information’’ DEPARTMENT OF HEALTH AND
program changes resulted in a 5,672- (¥ 0.25 hours). Based on our review of HUMAN SERVICES
hour decrease to the overall total hour the program, we believe these changes
burden estimate for this information to the burden estimate will more Food and Drug Administration
collection request. accurately reflect the current [Docket No. FDA–2014–D–0609]
• We adjusted the number of preparation time for these ICs.
respondents based on updated Agency Information Collection
registration and listing data. Dated: November 28, 2018.
Activities; Submission for Office of
• In the reporting burden table, we Leslie Kux,
Management and Budget Review;
corrected the table footnotes to Associate Commissioner for Policy. Comment Request; Drug Supply Chain
accurately indicate whether the [FR Doc. 2018–26303 Filed 12–3–18; 8:45 am] Security Act Implementation:
information collection (IC) is a one-time BILLING CODE 4164–01–P Identification of Suspect Product and
or reoccurring burden. Notification
• We also adjusted some of the IC
descriptions in the table for increased AGENCY: Food and Drug Administration,
clarity. HHS.
• We updated our estimate of Hours ACTION: Notice.
per Response for ‘‘807.22(a) Initial
Registration and Listing’’ (+ 0.5 hours), SUMMARY: The Food and Drug
‘‘807.22(b)(1) Annual Registration’’ Administration (FDA) is announcing
(¥ 0.25 hours), and ‘‘807.22(b)(3) that a proposed collection of
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Document Created: 2018-12-04 00:43:08
Document Modified: 2018-12-04 00:43:08
| 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 | Submit either electronic or written comments on the collection of information by February 4, 2019. | |
| 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 62583 |
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