81 FR 21579 - Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 70 (April 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21579-21581 | |
| FR Document | 2016-08338 |
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)] [Notices] [Pages 21579-21581] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08338] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos.: FDA-2014-E-2355; FDA-2014-E-2356; and FDA-2014-E-2357] Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for [[Page 21580]] GAZYVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 13, 2016. 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 October 11, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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 Nos. FDA-2014-E-2355; FDA-2014-E-2356; and FDA-2014-E-2357 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological 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 biologic product GAZYVA (obinutuzumab). GAZYVA is indicated, in addition with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. Subsequent to this approval, the U.S. Patent and Trademark Office (USPTO) received patent term restoration applications for GAZYVA (U.S. Patent Nos. 6,602,684; 7,517,670; and 8,021,856) from Genentech, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this human biological product had undergone a [[Page 21581]] regulatory review period and that the approval of GAZYVA 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 GAZYVA is 1,698 days. Of this time, 1,504 days occurred during the testing phase of the regulatory review period, while 194 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 (21 U.S.C. 355(i)) became effective: March 11, 2009. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on March 11, 2009. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): April 22, 2013. FDA has verified the applicant's claim that the biologics license application (BLA) for GAZYVA (BLA 125486) was initially submitted on April 22, 2013. 3. The date the application was approved: November 1, 2013. FDA has verified the applicant's claim that BLA 125486 was approved on November 1, 2013. 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 applications for patent extension, this applicant seeks 929, 946, or 484 days, respectively, 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 ask for a redetermination (see DATES). 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. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation (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 http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-08338 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21579
under the U.S. Department of standards will identify and maintain program and must be available to verify
Agriculture jurisdiction, are safe, program improvements that will the implementation of each standard.
wholesome, and labeled properly. States strengthen the safety and integrity of the The feed standards are not intended to
are responsible for conducting U.S. animal feed supply. address the performance appraisal
inspections and regulatory activities The feed standards are the framework processes that a State agency may use to
that help ensure food and feed that each State should use to design, evaluate individual employee
produced, processed, and distributed manage, and improve its feed program. performance.
within their jurisdictions are safe and in The standards include the following: (1) In the first year of implementation,
compliance with State laws and Regulatory foundation; (2) training; (3) the State program uses the self-
regulations. States primarily perform inspection program; (4) auditing; (5) assessment worksheets to determine if
inspections under their own regulatory feed-related illness or death and the requirements for each standard are
authority. Some States conduct emergency response; (6) enforcement fully met, partially met, or not met. The
inspections of feed facilities under program; (7) outreach activities; (8) self-assessments are used to develop an
contract with FDA. Because budget and planning; (9) assessment and improvement plan for fully
jurisdictions may overlap, FDA and improvement; (10) laboratory services; implementing the requirements of the
States collaborate and share resources to and (11) sampling program. 11 standards. Second and third-year
protect animal feed. Each standard has a purpose
assessments will provide progress
The FDA Food Safety Modernization statement, requirement summary,
evaluation.
Act passed on January 4, 2011, calls for description of program elements,
projected outcomes, and a list of Although FDA plans to provide
enhanced partnerships and provides a
required documentation. When a State financial support to State programs that
legal mandate for developing an
program voluntarily agrees to implement the feed standards, funding
Integrated Food Safety System (IFSS).
implement the feed standards, it must opportunities are contingent upon the
FDA is committed to implementing an
fully implement and maintain the availability of funds. Funding
IFSS thereby optimizing coordination of
individual program elements and opportunities may be only available to
food and feed safety efforts with
documentation requirements in each State feed regulatory programs that
Federal, State, local, tribal, and
standard in order to fully implement the currently have an FDA feed inspection
territorial regulatory and public health
standard. contract. State programs receiving
agencies. Model standards provide a
The feed standards package includes financial support to implement the feed
consistent, underlying foundation that
forms, worksheets, and templates to standards will be audited by FDA.
is critical for uniformity across State
and Federal Agencies to ensure help the State program assess and meet III. Electronic Access
credibility of food and feed programs the program elements in the standard.
within the IFSS. State programs are not obligated to use Persons with access to the Internet
the forms, worksheets, and templates may submit requests for a single copy of
II. Significance of Feed Program provided with the feed standards. Other the current feed standards from
Standards manual or automated forms, worksheets, ORAHQOPIO@fda.hhs.gov. Please note
The AFRPS provide a uniform and and templates may be used as long as that due to editorial revisions and
consistent approach to feed regulation the pertinent data elements are present. public comments, the final standards
in the United States. Implementation of Records and other documents specified may differ from the copy you receive.
the draft feed program standards is in the feed standards must be FDA estimates the burden of this
voluntary. States implementing the maintained in good order by the State collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average bur-
Number of Total annual
Type of respondent records per den per rec- Total hours
recordkeepers records
recordkeeper ordkeeping
State Employee .................................................................... 40 1 40 3,000 120,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to Dated: April 6, 2016. DEPARTMENT OF HEALTH AND
3,000 hours per respondent. This Leslie Kux, HUMAN SERVICES
burden was determined by capturing the Associate Commissioner for Policy.
average amount of time for each Food and Drug Administration
[FR Doc. 2016–08331 Filed 4–11–16; 8:45 am]
respondent to assess the current state of BILLING CODE 4164–01–P [Docket Nos.: FDA–2014–E–2355; FDA–
the program and work toward 2014–E–2356; and FDA–2014–E–2357]
implementation of each of the 11
standards contained in AFRPS. FDA Determination of Regulatory Review
recognizes that full use and Period for Purposes of Patent
asabaliauskas on DSK3SPTVN1PROD with NOTICES
implementation of the feed standards by Extension; GAZYVA
State feed programs will occur over AGENCY: Food and Drug Administration,
many years and the number of years to HHS.
fully implement the feed standards will ACTION: Notice.
vary among States.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
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![Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21581
regulatory review period and that the No. FDA–2013–S–0610. Submit written Building, we will need to receive RSVPs
approval of GAZYVA represented the petitions (two copies are required) to the for this event. Please send your full
first permitted commercial marketing or Division of Dockets Management (HFA– name and organization to OGA.RSVP@
use of the product. Thereafter, the 305), Food and Drug Administration, hhs.gov. If you are not a U.S. citizen,
USPTO requested that FDA determine 5630 Fishers Lane, Rm. 1061, Rockville, please note this in the subject line of
the product’s regulatory review period. MD 20852. your RSVP, and our office will contact
Dated: April 6, 2016. you to gain additional biographical
II. Determination of Regulatory Review
Leslie Kux,
information for your clearance. Please
Period
RSVP no later than Wednesday, April
FDA has determined that the Associate Commissioner for Policy.
27, 2016.
applicable regulatory review period for [FR Doc. 2016–08338 Filed 4–11–16; 8:45 am]
Written comments are welcome and
GAZYVA is 1,698 days. Of this time, BILLING CODE 4164–01–P encouraged, even if you are planning on
1,504 days occurred during the testing attending in person. Please send these to
phase of the regulatory review period, the email address: OGA.RSVP@hhs.gov.
while 194 days occurred during the DEPARTMENT OF HEALTH AND We look forward to hearing your
approval phase. These periods of time HUMAN SERVICES comments relative to the 69th World
were derived from the following dates: Health Assembly agenda items.
1. The date an exemption under Office of Global Affairs: Stakeholder
Listening Session in Preparation for Dated: March 14, 2016.
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)) the 69th World Health Assembly Jimmy Kolker,
became effective: March 11, 2009. FDA Assistant Secretary for Global Affairs.
Time and date: May 6th, 2016, 10:30
has verified the applicant’s claim that a.m.–12:00 Noon EST. [FR Doc. 2016–08287 Filed 4–11–16; 8:45 am]
the date the investigational new drug Place: Hubert H. Humphrey Building, BILLING CODE 4150–38–P
application became effective was on Room 505A, 200 Independence Ave.
March 11, 2009. SW., Washington, District of Columbia
2. The date the application was 20201. DEPARTMENT OF HEALTH AND
initially submitted with respect to the Status: Open, but requiring RSVP to HUMAN SERVICES
human biological product under section OGA.RSVP@hhs.gov.
351 of the Public Health Service Act (42 Purpose: The U.S. Department of Announcement of Establishment of the
U.S.C. 262): April 22, 2013. FDA has Health and Human Services (HHS)— Secretary’s Advisory Committee on
verified the applicant’s claim that the charged with leading the U.S. delegation National Health Promotion and Disease
biologics license application (BLA) for to the 69th World Health Assembly— Prevention Objectives for 2030 and
GAZYVA (BLA 125486) was initially will hold an informal Stakeholder Solicitation of Nominations for
submitted on April 22, 2013. Listening Session on Friday, May 6, Membership; Correction
3. The date the application was 10:30 a.m.–12:00 noon, in Conference AGENCY: Office of Disease Prevention
approved: November 1, 2013. FDA has Room 505A of the Hubert H. Humphrey and Health Promotion, Office of the
verified the applicant’s claim that BLA Building, 200 Independence Ave. S.W., Assistant Secretary for Health, Office of
125486 was approved on November 1, Washington, DC 20201. the Secretary, U.S. Department of Health
2013. The Stakeholder Listening Session and Human Services.
This determination of the regulatory will help the HHS Office of Global ACTION: Notice; correction.
review period establishes the maximum Affairs prepare the U.S. delegation for
potential length of a patent extension. the World Health Assembly by taking SUMMARY: The U.S. Department of
However, the USPTO applies several full advantage of the knowledge, ideas, Health and Human Services published a
statutory limitations in its calculations feedback, and suggestions from all notice in the Federal Register, dated
of the actual period for patent extension. communities interested in and affected March 17, 2016, to announce the
In its applications for patent extension, by agenda items to be discussed at the establishment of the Secretary’s
this applicant seeks 929, 946, or 484 69th World Health Assembly. Your Advisory Committee on National Health
days, respectively, of patent term input will contribute to U.S. positions Promotion and Disease Prevention
extension. as we negotiate with our international Objectives for 2030 (Committee) and
III. Petitions colleagues at the World Health invites nominations for membership.
Assembly these important health topics. This notice contained incorrect
Anyone with knowledge that any of The listening session will be information.
the dates as published are incorrect may organized by agenda item, and
submit either electronic or written FOR FURTHER INFORMATION CONTACT:
participation is welcome from all
comments and ask for a redetermination individuals, particularly members of Emmeline Ochiai, email address:
(see DATES). Furthermore, any interested stakeholder communities, including: HP2030@hhs.gov.
person may petition FDA for a • Public health and advocacy groups; Correction
determination regarding whether the • State, local, and Tribal groups;
applicant for extension acted with due • Private industry; In the Federal Register, dated March
diligence during the regulatory review • Minority health organizations; and 17, 2016, on page 14455, correct the
period. To meet its burden, the petition • Academic and scientific Title to read:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
must be timely (see DATES) and contain organizations. Announcement of Intent to Establish the
sufficient facts to merit an FDA All agenda items to be discussed at Secretary’s Advisory Committee on National
investigation (See H. Rept. 857, part 1, the 69th World Health Assembly can be Health Promotion and Disease Prevention
98th Cong., 2d sess., pp. 41–42, 1984). found at this Web site: http:// Objectives for 2030 and Solicitation of
Nominations for Membership
Petitions should be in the format apps.who.int/gb/ebwha/pdf_files/
specified in 21 CFR 10.30. WHA69/A69_1-en.pdf. and correct the SUMMARY to read:
Submit petitions electronically to RSVP: Due to security restrictions for SUMMARY: The U.S. Department of Health and
http://www.regulations.gov at Docket entry into the HHS Hubert H. Humphrey Human Services (HHS) announces its intent
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Document Created: 2016-04-12 00:47:17
Document Modified: 2016-04-12 00:47:17
| 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 | Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 13, 2016. 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 October 11, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 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. | |
| FR Citation | 81 FR 21579 |
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