82_FR_56480 82 FR 56253 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA

82 FR 56253 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 227 (November 28, 2017)

Page Range56253-56255
FR Document2017-25682

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZERBAXA 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 82 Issue 227 (Tuesday, November 28, 2017) 
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56253-56255]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25682]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0623]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for ZERBAXA 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 January 
29, 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 29, 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.

[[Page 56254]]

     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-0623 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ZERBAXA.'' 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 ZERBAXA 
(ceftolozane sulfate and tazobactam sodium). ZERBAXA is indicated for 
the treatment of the following infections caused by designated 
susceptible micro-organisms:
     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 ZERBAXA (U.S. Patent No. 7,129,232) from 
Astellas Pharma, Inc. and Wakunaga Pharmaceutical Co. Ltd., and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated May 10, 
2016, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of ZERBAXA 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 
ZERBAXA is 2,360 days. Of this time, 2,117 days occurred during the 
testing phase of the regulatory review period, while 243 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: July 5, 2008. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on July 5, 2008.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: April 21, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for ZERBAXA (NDA 206829) was initially submitted on 
April 21, 2014.
    3. The date the application was approved: December 19, 2014. FDA 
has verified the applicant's claim that NDA 206829 was approved on 
December 19, 2014.
    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 1,302 days of patent term extension.

[[Page 56255]]

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.) 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: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25682 Filed 11-27-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 56253 with the initial submission of an SAVAYSA (NDA 206316) was initially ACTION: Notice. application to market the human drug submitted on January 8, 2014. product and continues until FDA grants 3. The date the application was SUMMARY: The Food and Drug permission to market the drug product. approved: January 8, 2015. FDA has Administration (FDA or the Agency) has Although only a portion of a regulatory verified the applicant’s claim that NDA determined the regulatory review period review period may count toward the 206316 was approved on January 8, for ZERBAXA and is publishing this actual amount of extension that the 2015. notice of that determination as required Director of USPTO may award (for This determination of the regulatory by law. FDA has made the example, half the testing phase must be review period establishes the maximum determination because of the subtracted as well as any time that may potential length of a patent extension. submission of an application to the have occurred before the patent was However, the USPTO applies several Director of the U.S. Patent and statutory limitations in its calculations Trademark Office (USPTO), Department issued), FDA’s determination of the of the actual period for patent extension. of Commerce, for the extension of a length of a regulatory review period for In its application for patent extension, patent which claims that human drug a human drug product will include all this applicant seeks 1,406 days of patent product. of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). term extension. DATES: Anyone with knowledge that any FDA has approved for marketing the III. Petitions of the dates as published (in the human drug product SAVAYSA SUPPLEMENTARY INFORMATION section) are Anyone with knowledge that any of incorrect may submit either electronic (edoxaban tosylate monohydrate). the dates as published are incorrect may SAVAYSA is indicated to reduce the or written comments and ask for a submit either electronic or written redetermination by January 29, 2018. risk of stroke and systemic embolism in comments and, under 21 CFR 60.24, ask patients with nonvalvular atrial Furthermore, any interested person may for a redetermination (see DATES). petition FDA for a determination fibrillation and is also indicated for the Furthermore, as specified in § 60.30 (21 treatment of deep vein thrombosis and regarding whether the applicant for CFR 60.30), any interested person may extension acted with due diligence pulmonary embolism following 5–10 petition FDA for a determination days of initial therapy with a parenteral during the regulatory review period by regarding whether the applicant for May 29, 2018. See ‘‘Petitions’’ in the anticoagulant. Subsequent to this extension acted with due diligence approval, the USPTO received a patent SUPPLEMENTARY INFORMATION section for during the regulatory review period. To more information. term restoration application for meet its burden, the petition must SAVAYSA (U.S. Patent No. 7,365,205) ADDRESSES: You may submit comments comply with all the requirements of as follows. Please note that late, from Daiichi Sankyo Co., Ltd., and the § 60.30, including but not limited to: USPTO requested FDA’s assistance in untimely filed comments will not be Must be timely (see DATES), must be considered. Electronic comments must determining this patent’s eligibility for filed in accordance with § 10.20, must patent term restoration. In a letter dated be submitted on or before January 29, contain sufficient facts to merit an FDA 2018. The https://www.regulations.gov July 12, 2016, FDA advised the USPTO investigation, and must certify that a that this human drug product had electronic filing system will accept true and complete copy of the petition comments until midnight Eastern Time undergone a regulatory review period has been served upon the patent and that the approval of SAVAYSA at the end of January 29, 2018. applicant. (See H. Rept. 857, part 1, 98th Comments received by mail/hand represented the first permitted Cong., 2d sess., pp. 41–42, 1984.) commercial marketing or use of the delivery/courier (for written/paper Petitions should be in the format submissions) will be considered timely product. Thereafter, the USPTO specified in 21 CFR 10.30. requested that FDA determine the if they are postmarked or the delivery Submit petitions electronically to service acceptance receipt is on or product’s regulatory review period. https://www.regulations.gov at Docket before that date. II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written Period petitions (two copies are required) to the Electronic Submissions Dockets Management Staff (HFA–305), Submit electronic comments in the FDA has determined that the Food and Drug Administration, 5630 following way: applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal: https:// SAVAYSA is 3,845 days. Of this time, 20852. www.regulations.gov. Follow the 3,479 days occurred during the testing instructions for submitting comments. Dated: November 22, 2017. phase of the regulatory review period, Comments submitted electronically, Leslie Kux, while 366 days occurred during the including attachments, to https:// approval phase. These periods of time Associate Commissioner for Policy. www.regulations.gov will be posted to were derived from the following dates: [FR Doc. 2017–25703 Filed 11–27–17; 8:45 am] the docket unchanged. Because your 1. The date an exemption under BILLING CODE 4164–01–P comment will be made public, you are section 505(i) of the Federal Food, Drug, solely responsible for ensuring that your and Cosmetic Act (the FD&C Act) (21 comment does not include any U.S.C. 355(i)) became effective: July 1, DEPARTMENT OF HEALTH AND HUMAN SERVICES confidential information that you or a 2004. FDA has verified the applicant’s third party may not wish to be posted, claim that July 1, 2004, is the date the Food and Drug Administration such as medical information, your or investigational new drug application anyone else’s Social Security number, or ethrower on DSK3G9T082PROD with NOTICES (IND) became effective. [Docket No. FDA–2016–E–0623] confidential business information, such 2. The date the application was as a manufacturing process. Please note Determination of Regulatory Review initially submitted with respect to the that if you include your name, contact Period for Purposes of Patent human drug product under section information, or other information that Extension; ZERBAXA 505(b) of the FD&C Act: January 8, 2014. identifies you in the body of your FDA has verified the applicant’s claim AGENCY: Food and Drug Administration, comments, that information will be that the new drug application (NDA) for HHS. posted on https://www.regulations.gov. VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1

56254 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices • If you want to submit a comment public dockets, see 80 FR 56469, sodium). ZERBAXA is indicated for the with confidential information that you September 18, 2015, or access the treatment of the following infections do not wish to be made available to the information at: https://www.gpo.gov/ caused by designated susceptible micro- public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- organisms: written/paper submission and in the 23389.pdf. • Complicated intra-abdominal manner detailed (see ‘‘Written/Paper Docket: For access to the docket to infections, used in combination with Submissions’’ and ‘‘Instructions’’). read background documents or the metronidazole and Written/Paper Submissions electronic and written/paper comments • Complicated urinary tract received, go to https:// infections, including pyelonephritis. Submit written/paper submissions as www.regulations.gov and insert the Subsequent to this approval, the follows: docket number, found in brackets in the USPTO received a patent term • Mail/Hand delivery/Courier (for heading of this document, into the restoration application for ZERBAXA written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts (U.S. Patent No. 7,129,232) from Management Staff (HFA–305), Food and and/or go to the Dockets Management Astellas Pharma, Inc. and Wakunaga Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Pharmaceutical Co. Ltd., and the Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. • For written/paper comments USPTO requested FDA’s assistance in submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: determining this patent’s eligibility for Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory patent term restoration. In a letter dated well as any attachments, except for Policy, Food and Drug Administration, May 10, 2016, FDA advised the USPTO information submitted, marked and 10903 New Hampshire Ave., Bldg. 51, that this human drug product had identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, undergone a regulatory review period as detailed in ‘‘Instructions.’’ 301–796–3600. and that the approval of ZERBAXA Instructions: All submissions received SUPPLEMENTARY INFORMATION: represented the first permitted must include the Docket No. FDA– commercial marketing or use of the I. Background product. Thereafter, the USPTO 2016–E–0623 for ‘‘Determination of Regulatory Review Period for Purposes The Drug Price Competition and requested that FDA determine the of Patent Extension; ZERBAXA.’’ Patent Term Restoration Act of 1984 product’s regulatory review period. Received comments, those filed in a (Pub. L. 98–417) and the Generic II. Determination of Regulatory Review timely manner (see ADDRESSES), will be Animal Drug and Patent Term Period placed in the docket and, except for Restoration Act (Pub. L. 100–670) those submitted as ‘‘Confidential generally provide that a patent may be FDA has determined that the Submissions,’’ publicly viewable at extended for a period of up to 5 years applicable regulatory review period for https://www.regulations.gov or at the so long as the patented item (human ZERBAXA is 2,360 days. Of this time, Dockets Management Staff between 9 drug product, animal drug product, 2,117 days occurred during the testing a.m. and 4 p.m., Monday through medical device, food additive, or color phase of the regulatory review period, Friday. additive) was subject to regulatory while 243 days occurred during the • Confidential Submissions—To 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 regulatory review period forms the basis 1. The date an exemption under made publicly available, submit your for determining the amount of extension section 505(i) of the Federal Food, Drug, comments only as a written/paper an applicant may receive. and Cosmetic Act (the FD&C Act) (21 submission. You should submit two A regulatory review period consists of U.S.C. 355(i)) became effective: July 5, copies total. One copy will include the two periods of time: A testing phase and 2008. FDA has verified the applicant’s information you claim to be confidential an approval phase. For human drug claim that the date the investigational with a heading or cover note that states products, the testing phase begins when new drug application became effective ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical was on July 5, 2008. CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes 2. The date the application was Agency will review this copy, including effective and runs until the approval initially submitted with respect to the the claimed confidential information, in phase begins. The approval phase starts human drug product under section its consideration of comments. The with the initial submission of an 505(b) of the FD&C Act: April 21, 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. ZERBAXA (NDA 206829) was initially for public viewing and posted on Although only a portion of a regulatory submitted on April 21, 2014. https://www.regulations.gov. Submit review period may count toward the 3. The date the application was both copies to the Dockets Management actual amount of extension that the approved: December 19, 2014. FDA has Staff. If you do not wish your name and 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 206829 was approved on December 19, available, you can provide this subtracted as well as any time that may 2014. information on the cover sheet and not have occurred before the patent was This determination of the regulatory in the body of your comments and you issued), FDA’s determination of the review period establishes the maximum ethrower on DSK3G9T082PROD with NOTICES must identify this information as length of a regulatory review period for potential length of a patent extension. ‘‘confidential.’’ Any information marked 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 ZERBAXA this applicant seeks 1,302 days of patent about FDA’s posting of comments to (ceftolozane sulfate and tazobactam term extension. VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1

Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 56255 III. Petitions Dated: November 21, 2017. Map Service Center at https:// Melanie J. Pantoja, msc.fema.gov for comparison. Anyone with knowledge that any of Program Analyst, Office of Federal Advisory You may submit comments, identified the dates as published are incorrect may Committee Policy. by Docket No. FEMA–B–1755, to Rick submit either electronic or written [FR Doc. 2017–25631 Filed 11–27–17; 8:45 am] Sacbibit, Chief, Engineering Services comments and, under 21 CFR 60.24, ask BILLING CODE 4140–01–P Branch, Federal Insurance and for a redetermination (see DATES). Mitigation Administration, FEMA, 400 Furthermore, as specified in § 60.30 (21 C Street SW., Washington, DC 20472, CFR 60.30), any interested person may DEPARTMENT OF HOMELAND (202) 646–7659, or (email) petition FDA for a determination SECURITY patrick.sacbibit@fema.dhs.gov. regarding whether the applicant for FOR FURTHER INFORMATION CONTACT: Rick extension acted with due diligence Federal Emergency Management Sacbibit, Chief, Engineering Services during the regulatory review period. To Agency Branch, Federal Insurance and meet its burden, the petition must Mitigation Administration, FEMA, 400 [Docket ID FEMA–2017–0002; Internal comply with all the requirements of Agency Docket No. FEMA–B–1755] C Street SW., Washington, DC 20472, § 60.30, including but not limited to: (202) 646–7659, or (email) Must be timely (see DATES), must be Proposed Flood Hazard patrick.sacbibit@fema.dhs.gov; or visit filed in accordance with § 10.20, must Determinations the FEMA Map Information eXchange contain sufficient facts to merit an FDA (FMIX) online at https:// AGENCY: Federal Emergency www.floodmaps.fema.gov/fhm/fmx_ investigation, and must certify that a Management Agency, DHS. true and complete copy of the petition main.html. ACTION: Notice. has been served upon the patent SUPPLEMENTARY INFORMATION: FEMA applicant. (See H. Rept. 857, part 1, 98th SUMMARY: Comments are requested on proposes to make flood hazard Cong., 2d sess., pp. 41–42, 1984.) proposed flood hazard determinations, determinations for each community Petitions should be in the format which may include additions or listed below, in accordance with section specified in 21 CFR 10.30. modifications of any Base Flood 110 of the Flood Disaster Protection Act Elevation (BFE), base flood depth, of 1973, 42 U.S.C. 4104, and 44 CFR Submit petitions electronically to 67.4(a). https://www.regulations.gov at Docket Special Flood Hazard Area (SFHA) boundary or zone designation, or These proposed flood hazard No. FDA–2013–S–0610. Submit written determinations, together with the petitions (two copies are required) to the regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and floodplain management criteria required Dockets Management Staff (HFA–305), by 44 CFR 60.3, are the minimum that where applicable, in the supporting Food and Drug Administration, 5630 are required. They should not be Flood Insurance Study (FIS) reports for Fishers Lane, Rm. 1061, Rockville, MD construed to mean that the community the communities listed in the table 20852. below. The purpose of this notice is to must change any existing ordinances Dated: November 22, 2017. seek general information and comment that are more stringent in their regarding the preliminary FIRM, and floodplain management requirements. Leslie Kux, where applicable, the FIS report that the The community may at any time enact Associate Commissioner for Policy. stricter requirements of its own or [FR Doc. 2017–25682 Filed 11–27–17; 8:45 am] Federal Emergency Management Agency (FEMA) has provided to the affected pursuant to policies established by other BILLING CODE 4164–01–P communities. The FIRM and FIS report Federal, State, or regional entities. are the basis of the floodplain These flood hazard determinations are management measures that the used to meet the floodplain DEPARTMENT OF HEALTH AND management requirements of the NFIP community is required either to adopt HUMAN SERVICES or to show evidence of having in effect and also are used to calculate the in order to qualify or remain qualified appropriate flood insurance premium National Institutes of Health rates for new buildings built after the for participation in the National Flood Insurance Program (NFIP). In addition, FIRM and FIS report become effective. National Institute on Alcohol Abuse The communities affected by the and Alcoholism Amended; Notice of the FIRM and FIS report, once effective, will be used by insurance agents and flood hazard determinations are Meeting provided in the tables below. Any others to calculate appropriate flood insurance premium rates for new request for reconsideration of the Notice is hereby given of a change in revised flood hazard information shown the meeting of the National Institute on buildings and the contents of those buildings. on the Preliminary FIRM and FIS report Alcohol Abuse and Alcoholism Special that satisfies the data requirements Emphasis Panel, December 11, 2017, DATES: Comments are to be submitted outlined in 44 CFR 67.6(b) is considered 1:00 p.m. to December 11, 2017, 3:30 on or before February 26, 2018. an appeal. Comments unrelated to the p.m., National Institute on Alcohol ADDRESSES: The Preliminary FIRM, and flood hazard determinations also will be Abuse and Alcoholism, 5635 Fishers where applicable, the FIS report for considered before the FIRM and FIS Lane, Bethesda, MD 20892 which was each community are available for report become effective. published in the Federal Register on inspection at both the online location Use of a Scientific Resolution Panel ethrower on DSK3G9T082PROD with NOTICES November 17, 2017, 82 FR 54389. https://www.fema.gov/ (SRP) is available to communities in preliminaryfloodhazarddata and the support of the appeal resolution This notice is amended to change the respective Community Map Repository process. SRPs are independent panels of meeting date from December 11, 2017 to address listed in the tables below. experts in hydrology, hydraulics, and December 13, 2017. The meeting time Additionally, the current effective FIRM other pertinent sciences established to and location remains the same. The and FIS report for each community are review conflicting scientific and meeting is closed to the public. accessible online through the FEMA technical data and provide VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1


Document Created: 2017-11-28 01:51:12
Document Modified: 2017-11-28 01:51:12
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 January 29, 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 May 29, 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 Citation82 FR 56253 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR