83 FR 2451 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 11 (January 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 11 (January 17, 2018)
| Page Range | 2451-2452 | |
| FR Document | 2018-00685 |
[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)] [Notices] [Pages 2451-2452] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00685] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-7012] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics 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 16, 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--NEW and title ``Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics.'' 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. Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics--OMB Control Number 0910--NEW This information collection supports the above captioned Agency guidance document. In the Federal Register of July 8, 2016 (81 FR 44611), FDA announced the availability of a draft guidance for industry entitled ``Use of Public Human Genetic Variant Databases To Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics,'' and included an analysis of the associated information collection. The draft guidance described FDA's considerations in determining whether a genetic variant database is a source of valid scientific evidence that could support the clinical validity of an NGS-based test. This draft guidance further outlines the process by which administrators \1\ of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. The draft guidance also recommends that, at the time of recognition, the database administrator make information regarding policies, procedures, and conflicts of interest publicly available and accessible on the genetic variant database's website. --------------------------------------------------------------------------- \1\ FDA acknowledges that many databases may not use the term ``administrator'' or may have a committee of individuals that oversee the database. Therefore, for the purpose of this guidance, a genetic variant database administrator is the entity or entities that oversee database operations. --------------------------------------------------------------------------- Based on our experience and the nature of the information, we estimate that it will take an average of 80 hours to complete and submit an application for recognition. We estimate that maintenance of recognition activities will take approximately one-fourth of that time (20 hours) annually. We estimate that it will take approximately 1 hour to post the information on the website. Respondents are administrators of genetic databases. Our estimate of five respondents per year is based on the current number of databases that may meet FDA recommendations for recognition and seek such recognition. FDA received 36 comments on the draft guidance, none of which pertained to the information collection burden estimate. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Application for recognition of genetic database.................... 5 1 5 80 400 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Maintenance of recognition activities.............................. 5 1 5 20 100 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 2452]] Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of disclosures Total annual Average burden Total hours respondents per respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Public disclosure of policies, procedures, and conflicts of 5 1 5 1 5 interest.......................................................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The draft guidance also refers to previously approved collections of information. These collections of information are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in the guidance document ``Requests for Feedback on Medical Device Submissions: The Pre- Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. The collections of information regarding premarket submissions have been approved as follows: The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231. Dated: January 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00685 Filed 1-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2451
Petitions should be in the format ADDRESSES: To ensure that comments on included an analysis of the associated
specified in 21 CFR 10.30. the information collection are received, information collection.
Submit petitions electronically to OMB recommends that written The draft guidance described FDA’s
https://www.regulations.gov at Docket comments be faxed to the Office of considerations in determining whether a
No. FDA–2013–S–0610. Submit written Information and Regulatory Affairs, genetic variant database is a source of
petitions (two copies are required) to the OMB, Attn: FDA Desk Officer, Fax: 202– valid scientific evidence that could
Dockets Management Staff (HFA–305), 395–7285, or emailed to oira_ support the clinical validity of an NGS-
Food and Drug Administration, 5630 submission@omb.eop.gov. All based test. This draft guidance further
Fishers Lane, Rm. 1061, Rockville, MD comments should be identified with the outlines the process by which
20852. OMB control number 0910—NEW and administrators 1 of genetic variant
Dated: January 11, 2018. title ‘‘Use of Public Human Genetic databases could voluntarily apply to
Leslie Kux, Variant Databases to Support Clinical FDA for recognition, and how FDA
Associate Commissioner for Policy. Validity for Genetic and Genomic-Based would review such applications and
[FR Doc. 2018–00678 Filed 1–16–18; 8:45 am]
In Vitro Diagnostics.’’ Also include the periodically reevaluate recognized
FDA docket number found in brackets databases. The draft guidance also
BILLING CODE 4164–01–P
in the heading of this document. recommends that, at the time of
FOR FURTHER INFORMATION CONTACT: recognition, the database administrator
DEPARTMENT OF HEALTH AND Amber Sanford, Office of Operations, make information regarding policies,
HUMAN SERVICES Food and Drug Administration, Three procedures, and conflicts of interest
White Flint North, 10A–12M, 11601 publicly available and accessible on the
Food and Drug Administration genetic variant database’s website.
Landsdown St., North Bethesda, MD
[Docket No. FDA–2017–N–7012] 20852, 301–796–8867, PRAStaff@ Based on our experience and the
fda.hhs.gov. nature of the information, we estimate
Agency Information Collection that it will take an average of 80 hours
Activities; Submission for Office of SUPPLEMENTARY INFORMATION: In to complete and submit an application
Management and Budget Review; compliance with 44 U.S.C. 3507, FDA for recognition. We estimate that
Comment Request; Use of Public has submitted the following proposed maintenance of recognition activities
Human Genetic Variant Databases To collection of information to OMB for will take approximately one-fourth of
Support Clinical Validity for Genetic review and clearance. that time (20 hours) annually. We
and Genomic-Based In Vitro estimate that it will take approximately
Diagnostics Use of Public Human Genetic Variant
Databases To Support Clinical Validity 1 hour to post the information on the
AGENCY: Food and Drug Administration, for Genetic and Genomic-Based In website.
HHS. Vitro Diagnostics—OMB Control Respondents are administrators of
ACTION: Notice. Number 0910—NEW genetic databases. Our estimate of five
respondents per year is based on the
SUMMARY: The Food and Drug This information collection supports current number of databases that may
Administration (FDA) is announcing the above captioned Agency guidance meet FDA recommendations for
that a proposed collection of document. In the Federal Register of recognition and seek such recognition.
information has been submitted to the July 8, 2016 (81 FR 44611), FDA
Office of Management and Budget announced the availability of a draft FDA received 36 comments on the
(OMB) for review and clearance under guidance for industry entitled ‘‘Use of draft guidance, none of which pertained
the Paperwork Reduction Act of 1995. Public Human Genetic Variant to the information collection burden
DATES: Fax written comments on the Databases To Support Clinical Validity estimate.
collection of information by February for Next Generation Sequencing (NGS)- FDA estimates the burden of this
16, 2018. Based In Vitro Diagnostics,’’ and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent
Application for recognition of genetic database .................. 5 1 5 80 400
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
Number of records Total annual
Activity burden per Total hours
recordkeepers per record- records recordkeeping
keeper
ethrower on DSK3G9T082PROD with NOTICES
Maintenance of recognition activities ................................... 5 1 5 20 100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
1 FDA acknowledges that many databases may not committee of individuals that oversee the database. genetic variant database administrator is the entity
use the term ‘‘administrator’’ or may have a Therefore, for the purpose of this guidance, a or entities that oversee database operations.
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![2452 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent
Public disclosure of policies, procedures, and conflicts of
interest .............................................................................. 5 1 5 1 5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The draft guidance also refers to Director of the U.S. Patent and comments, that information will be
previously approved collections of Trademark Office (USPTO), Department posted on https://www.regulations.gov.
information. These collections of of Commerce, for the extension of a • If you want to submit a comment
information are subject to review by the patent which claims that medical with confidential information that you
OMB under the Paperwork Reduction device. do not wish to be made available to the
Act of 1995 (44 U.S.C. 3501–3520). The DATES: Anyone with knowledge that any
public, submit the comment as a
collections of information in the of the dates as published (in the written/paper submission and in the
guidance document ‘‘Requests for SUPPLEMENTARY INFORMATION section) are
manner detailed (see ‘‘Written/Paper
Feedback on Medical Device incorrect may submit either electronic Submissions’’ and ‘‘Instructions’’).
Submissions: The Pre-Submission or written comments and ask for a Written/Paper Submissions
Program and Meetings with Food and redetermination by March 19, 2018.
Drug Administration Staff’’ have been Submit written/paper submissions as
Furthermore, any interested person may follows:
approved under OMB control number petition FDA for a determination
0910–0756. The collections of • Mail/Hand delivery/Courier (for
regarding whether the applicant for written/paper submissions): Dockets
information regarding premarket extension acted with due diligence Management Staff (HFA–305), Food and
submissions have been approved as during the regulatory review period by Drug Administration, 5630 Fishers
follows: The collections of information July 16, 2018. See ‘‘Petitions’’ in the Lane, Rm. 1061, Rockville, MD 20852.
in 21 CFR part 807, subpart E, have been SUPPLEMENTARY INFORMATION section for • For written/paper comments
approved under OMB control number more information. submitted to the Dockets Management
0910–0120 and the collections of ADDRESSES: You may submit comments Staff, FDA will post your comment, as
information in 21 CFR part 814, as follows. Please note that late, well as any attachments, except for
subparts A through E, have been untimely filed comments will not be information submitted, marked and
approved under OMB control number considered. Electronic comments must identified, as confidential, if submitted
0910–0231. be submitted on or before March 19, as detailed in ‘‘Instructions.’’
Dated: January 11, 2018. 2018. The https://www.regulations.gov Instructions: All submissions received
Leslie Kux, electronic filing system will accept must include the Docket No. FDA–
Associate Commissioner for Policy. comments until midnight Eastern Time 2016–E–2227 for ‘‘Determination of
[FR Doc. 2018–00685 Filed 1–16–18; 8:45 am]
at the end of March 19, 2018. Comments Regulatory Review Period for Purposes
received by mail/hand delivery/courier of Patent Extension; SYNERGY
BILLING CODE 4164–01–P
(for written/paper submissions) will be EVEROLIMUS–ELUTING PLATINUM
considered timely if they are CHROMIUM CORONARY STENT
DEPARTMENT OF HEALTH AND postmarked or the delivery service SYSTEM.’’ Received comments, those
HUMAN SERVICES acceptance receipt is on or before that filed in a timely manner (see
date. ADDRESSES), will be placed in the docket
Food and Drug Administration and, except for those submitted as
Electronic Submissions
‘‘Confidential Submissions,’’ publicly
[Docket No. FDA–2016–E–2227] Submit electronic comments in the viewable at https://www.regulations.gov
following way: or at the Dockets Management Staff
Determination of Regulatory Review • Federal eRulemaking Portal:
Period for Purposes of Patent between 9 a.m. and 4 p.m., Monday
https://www.regulations.gov. Follow the through Friday.
Extension; SYNERGY EVEROLIMUS– instructions for submitting comments. • Confidential Submissions—To
ELUTING PLATINUM CHROMIUM Comments submitted electronically, submit a comment with confidential
CORONARY STENT SYSTEM including attachments, to https:// information that you do not wish to be
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to made publicly available, submit your
HHS. the docket unchanged. Because your comments only as a written/paper
ACTION: Notice. comment will be made public, you are submission. You should submit two
solely responsible for ensuring that your copies total. One copy will include the
SUMMARY: The Food and Drug comment does not include any information you claim to be confidential
Administration (FDA or the Agency) has confidential information that you or a with a heading or cover note that states
determined the regulatory review period third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
ethrower on DSK3G9T082PROD with NOTICES
for SYNERGY EVEROLIMUS–ELUTING such as medical information, your or CONFIDENTIAL INFORMATION.’’ The
PLATINUM CHROMIUM CORONARY anyone else’s Social Security number, or Agency will review this copy, including
STENT SYSTEM and is publishing this confidential business information, such the claimed confidential information, in
notice of that determination as required as a manufacturing process. Please note its consideration of comments. The
by law. FDA has made the that if you include your name, contact second copy, which will have the
determination because of the information, or other information that claimed confidential information
submission of an application to the identifies you in the body of your redacted/blacked out, will be available
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Document Created: 2018-10-26 09:56:17
Document Modified: 2018-10-26 09:56:17
| 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 16, 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 2451 |
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