83_FR_2460 83 FR 2449 - Determination of Regulatory Review Period for Purposes of Patent Extension; AVYCAZ

83 FR 2449 - Determination of Regulatory Review Period for Purposes of Patent Extension; AVYCAZ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 11 (January 17, 2018)

Page Range2449-2451
FR Document2018-00678

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AVYCAZ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 83 Issue 11 (Wednesday, January 17, 2018) 
[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2449-2451]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1235]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; AVYCAZ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for AVYCAZ and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by March 
19, 2018. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by July 16, 2018. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

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 March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of March 19, 2018. 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-2016-E-1235 for ``Determination of

[[Page 2450]]

Regulatory Review Period for Purposes of Patent Extension; AVYCAZ.'' 
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 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 Sec.  10.20 (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: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Director of USPTO may award 
(for example, half the testing phase must be subtracted as well as any 
time that may have occurred before the patent was issued), FDA's 
determination of the length of a regulatory review period for a human 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product AVYCAZ 
(ceftazidime pentahydrate and avibactam sodium). AVYCAZ is indicated 
for treatment of patients 18 years or older with the following 
infections caused by designated susceptible microorganisms:
     Complicated intra-abdominal infections used in combination 
with metronidazole and
     Complicated urinary tract infections, including 
pyelonephritis.
    Subsequent to this approval, the USPTO received a patent term 
restoration application for AVYCAZ (U.S. Patent No. 7,112,592) from 
Forest Laboratories Holdings Ltd., and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated July 12, 2016, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of AVYCAZ represented the first permitted 
commercial marketing or use of the product. Thereafter, the USPTO 
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
AVYCAZ is 2,579 days. Of this time, 2,333 days occurred during the 
testing phase of the regulatory review period, while 246 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: February 5, 2008. FDA has verified the applicant's claim 
that February 5, 2008, is the date the investigational new drug 
application (IND) became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: June 25, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for AVYCAZ (NDA 206494) was initially submitted on 
June 25, 2014.
    3. The date the application was approved: February 25, 2015. FDA 
has verified the applicant's claim that NDA 206494 was approved on 
February 25, 2015.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 1,411 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are 
incorrect may submit either electronic or written comments and, under 
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as 
specified in Sec.  60.30 (21 CFR 60.30), any interested person may 
petition FDA for a determination regarding whether the applicant for 
extension acted with due diligence during the regulatory review period. 
To meet its burden, the petition must comply with all the requirements 
of Sec.  60.30, including but not limited to: Must be timely (see 
DATES), must be filed in accordance with Sec.  10.20, must contain 
sufficient facts to merit an FDA investigation, and must certify that a 
true and complete copy of the petition has been served upon the patent 
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 
1984.)

[[Page 2451]]

Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00678 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2449 To obtain copies of a supporting this authority, regulations establishing July 16, 2018. See ‘‘Petitions’’ in the statement and any related forms for the the certified application counselor SUPPLEMENTARY INFORMATION section for proposed collection(s) summarized in program have been finalized at 45 CFR more information. this notice, you may make your request 155.225. In accordance with ADDRESSES: You may submit comments using one of following: 155.225(d)(1) and (7), certified as follows. Please note that late, 1. Access CMS’ website address at application counselors in all Exchanges untimely filed comments will not be http://www.cms.hhs.gov/Paperwork are required to be initially certified and considered. Electronic comments must ReductionActof1995. recertified on at least an annual basis be submitted on or before March 19, 2. Email your request, including your and successfully complete Exchange- 2018. The https://www.regulations.gov address, phone number, OMB number, required training. Form Number: CMS– electronic filing system will accept and CMS document identifier, to 10494 (OMB control number: 0938– comments until midnight Eastern Time Paperwork@cms.hhs.gov. 1205); Frequency: On Occasion; at the end of March 19, 2018. Comments 3. Call the Reports Clearance Office at Affected Public: State, Local, or Tribal received by mail/hand delivery/courier (410) 786–1326. Governments, Private Sector (not-for- (for written/paper submissions) will be FOR FURTHER INFORMATION CONTACT: profit institutions); individuals or considered timely if they are William Parham at (410) 786–4669. households; Number of Respondents: postmarked or the delivery service SUPPLEMENTARY INFORMATION: 30,000; Total Annual Responses: acceptance receipt is on or before that 30,000; Total Annual Hours: 7,500. For date. Contents policy questions regarding this This notice sets out a summary of the Electronic Submissions collection contact Deborah Bryant at use and burden associated with the 301–492–5213. Submit electronic comments in the following information collections. More following way: Dated: January 10, 2018. detailed information can be found in • Federal eRulemaking Portal: William N. Parham, III, https://www.regulations.gov. Follow the each collection’s supporting statement and associated materials (see Director, Paperwork Reduction Staff, Office instructions for submitting comments. of Strategic Operations and Regulatory Comments submitted electronically, ADDRESSES). Affairs. CMS–10494 Exchange Functions: including attachments, to https:// [FR Doc. 2018–00632 Filed 1–16–18; 8:45 am] www.regulations.gov will be posted to Standards for Navigators and Non- Navigator Assistance Personnel— BILLING CODE 4120–01–P the docket unchanged. Because your CAC comment will be made public, you are solely responsible for ensuring that your Under the PRA (44 U.S.C. 3501– DEPARTMENT OF HEALTH AND comment does not include any 3520), federal agencies must obtain HUMAN SERVICES confidential information that you or a approval from the Office of Management third party may not wish to be posted, and Budget (OMB) for each collection of Food and Drug Administration such as medical information, your or information they conduct or sponsor. [Docket No. FDA–2016–E–1235] anyone else’s Social Security number, or The term ‘‘collection of information’’ is confidential business information, such defined in 44 U.S.C. 3502(3) and 5 CFR Determination of Regulatory Review as a manufacturing process. Please note 1320.3(c) and includes agency requests Period for Purposes of Patent that if you include your name, contact or requirements that members of the Extension; AVYCAZ information, or other information that public submit reports, keep records, or identifies you in the body of your provide information to a third party. AGENCY: Food and Drug Administration, HHS. comments, that information will be Section 3506(c)(2)(A) of the PRA posted on https://www.regulations.gov. requires federal agencies to publish a ACTION: Notice. • If you want to submit a comment 60-day notice in the Federal Register with confidential information that you SUMMARY: The Food and Drug concerning each proposed collection of do not wish to be made available to the Administration (FDA or the Agency) has information, including each proposed public, submit the comment as a determined the regulatory review period extension or reinstatement of an existing written/paper submission and in the for AVYCAZ and is publishing this collection of information, before manner detailed (see ‘‘Written/Paper notice of that determination as required submitting the collection to OMB for Submissions’’ and ‘‘Instructions’’). by law. FDA has made the approval. To comply with this determination because of the Written/Paper Submissions requirement, CMS is publishing this submission of an application to the notice. Submit written/paper submissions as Director of the U.S. Patent and Information Collection Trademark Office (USPTO), Department follows: • Mail/Hand delivery/Courier (for 1. Type of Information Collection of Commerce, for the extension of a written/paper submissions): Dockets Request: Revision of a previously patent which claims that human drug Management Staff (HFA–305), Food and approved collection; Title of product. Drug Administration, 5630 Fishers Information Collection: Exchange DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. Functions: Standards for Navigators and of the dates as published (in the • For written/paper comments Non-Navigator Assistance Personnel— SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management CAC; Use: Section 1321(a)(1) of the incorrect may submit either electronic Staff, FDA will post your comment, as ethrower on DSK3G9T082PROD with NOTICES Affordable Care Act directs and or written comments and ask for a well as any attachments, except for authorizes the Secretary to issue redetermination by March 19, 2018. information submitted, marked and regulations setting standards for meeting Furthermore, any interested person may identified, as confidential, if submitted the requirements under title I of the petition FDA for a determination as detailed in ‘‘Instructions.’’ Affordable Care Act, with respect to, regarding whether the applicant for Instructions: All submissions received among other things, the establishment extension acted with due diligence must include the Docket No. FDA– and operation of Exchanges. Pursuant to during the regulatory review period by 2016–E–1235 for ‘‘Determination of VerDate Sep<11>2014 17:14 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1

2450 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices Regulatory Review Period for Purposes I. Background product. Thereafter, the USPTO of Patent Extension; AVYCAZ.’’ The Drug Price Competition and requested that FDA determine the Received comments, those filed in a Patent Term Restoration Act of 1984 product’s regulatory review period. timely manner (see ADDRESSES), will be (Pub. L. 98–417) and the Generic II. Determination of Regulatory Review placed in the docket and, except for Animal Drug and Patent Term Period those submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670) Submissions,’’ publicly viewable at generally provide that a patent may be FDA has determined that the https://www.regulations.gov or at the extended for a period of up to 5 years applicable regulatory review period for Dockets Management Staff between 9 so long as the patented item (human AVYCAZ is 2,579 days. Of this time, a.m. and 4 p.m., Monday through drug product, animal drug product, 2,333 days occurred during the testing Friday. medical device, food additive, or color phase of the regulatory review period, while 246 days occurred during the • Confidential Submissions—To additive) was subject to regulatory review by FDA before the item was approval phase. These periods of time submit a comment with confidential marketed. Under these acts, a product’s were derived from the following dates: information that you do not wish to be made publicly available, submit your regulatory review period forms the basis 1. The date an exemption under comments only as a written/paper for determining the amount of extension section 505(i) of the Federal Food, Drug, submission. You should submit two an applicant may receive. and Cosmetic Act (the FD&C Act) (21 copies total. One copy will include the A regulatory review period consists of U.S.C. 355(i)) became effective: two periods of time: A testing phase and February 5, 2008. FDA has verified the information you claim to be confidential an approval phase. For human drug applicant’s claim that February 5, 2008, with a heading or cover note that states products, the testing phase begins when is the date the investigational new drug ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical application (IND) became effective. CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including investigations of the drug becomes 2. The date the application was the claimed confidential information, in effective and runs until the approval initially submitted with respect to the its consideration of comments. The phase begins. The approval phase starts human drug product under section with the initial submission of an 505(b) of the FD&C Act: June 25, 2014. second copy, which will have the application to market the human drug FDA has verified the applicant’s claim claimed confidential information product and continues until FDA grants that the new drug application (NDA) for redacted/blacked out, will be available permission to market the drug product. AVYCAZ (NDA 206494) was initially for public viewing and posted on Although only a portion of a regulatory submitted on June 25, 2014. https://www.regulations.gov. Submit both copies to the Dockets Management review period may count toward the 3. The date the application was Staff. If you do not wish your name and actual amount of extension that the approved: February 25, 2015. FDA has Director of USPTO may award (for verified the applicant’s claim that NDA contact information to be made publicly example, half the testing phase must be 206494 was approved on February 25, available, you can provide this subtracted as well as any time that may 2015. information on the cover sheet and not in the body of your comments and you have occurred before the patent was This determination of the regulatory must identify this information as issued), FDA’s determination of the review period establishes the maximum ‘‘confidential.’’ Any information marked length of a regulatory review period for potential length of a patent extension. a human drug product will include all However, the USPTO applies several as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase statutory limitations in its calculations except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). of the actual period for patent extension. CFR 10.20) and other applicable FDA has approved for marketing the In its application for patent extension, disclosure law. For more information human drug product AVYCAZ this applicant seeks 1,411 days of patent about FDA’s posting of comments to (ceftazidime pentahydrate and term extension. public dockets, see 80 FR 56469, avibactam sodium). AVYCAZ is III. Petitions September 18, 2015, or access the indicated for treatment of patients 18 information at: https://www.gpo.gov/ Anyone with knowledge that any of years or older with the following fdsys/pkg/FR-2015-09-18/pdf/2015- the dates as published are incorrect may infections caused by designated 23389.pdf. submit either electronic or written susceptible microorganisms: Docket: For access to the docket to • Complicated intra-abdominal comments and, under 21 CFR 60.24, ask read background documents or the infections used in combination with for a redetermination (see DATES). electronic and written/paper comments metronidazole and Furthermore, as specified in § 60.30 (21 received, go to https:// • Complicated urinary tract CFR 60.30), any interested person may www.regulations.gov and insert the infections, including pyelonephritis. petition FDA for a determination docket number, found in brackets in the Subsequent to this approval, the regarding whether the applicant for heading of this document, into the USPTO received a patent term extension acted with due diligence ‘‘Search’’ box and follow the prompts restoration application for AVYCAZ during the regulatory review period. To and/or go to the Dockets Management (U.S. Patent No. 7,112,592) from Forest meet its burden, the petition must Staff, 5630 Fishers Lane, Rm. 1061, Laboratories Holdings Ltd., and the comply with all the requirements of Rockville, MD 20852. USPTO requested FDA’s assistance in § 60.30, including but not limited to: determining this patent’s eligibility for Must be timely (see DATES), must be ethrower on DSK3G9T082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: patent term restoration. In a letter dated filed in accordance with § 10.20, must Beverly Friedman, Office of Regulatory July 12, 2016, FDA advised the USPTO contain sufficient facts to merit an FDA Policy, Food and Drug Administration, that this human drug product had investigation, and must certify that a 10903 New Hampshire Ave., Bldg. 51, undergone a regulatory review period true and complete copy of the petition Rm. 6250, Silver Spring, MD 20993, and that the approval of AVYCAZ has been served upon the patent 301–796–3600. represented the first permitted applicant. (See H. Rept. 857, part 1, 98th SUPPLEMENTARY INFORMATION: commercial marketing or use of the Cong., 2d sess., pp. 41–42, 1984.) VerDate Sep<11>2014 17:14 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1

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. VerDate Sep<11>2014 17:14 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1


Document Created: 2018-10-26 09:55:09
Document Modified: 2018-10-26 09:55:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by March 19, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 16, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation83 FR 2449 
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