81 FR 66662 - Determination of Regulatory Review Period for Purposes of Patent Extension; IONSYS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 188 (September 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 188 (September 28, 2016)
| Page Range | 66662-66664 | |
| FR Document | 2016-23330 |
[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)] [Notices] [Pages 66662-66664] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23330] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0400] Determination of Regulatory Review Period for Purposes of Patent Extension; IONSYS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for IONSYS 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 November 28, 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 March 27, 2017. 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 [[Page 66663]] 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 No. FDA-2007-E-0400, ``Determination of Regulatory Review Period for Purposes of Patent Extension; IONSYS.'' 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 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 IONSYS (fentanyl hydrochloride). IONSYS is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Subsequent to this approval, the USPTO received a patent term restoration application for IONSYS (U.S. Patent No. 5,697,896) from Alza Corp., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration and the product's regulatory review period. In a letter dated August 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of IONSYS represented the first permitted commercial marketing or use of the product. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for IONSYS is 4,835 days. Of this time, 3,862 days occurred during the testing phase of the regulatory review period, while 973 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 26, 1993. The applicant claims February 27, 1993, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was February 26, 1993, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 23, 2003. FDA has verified the applicant's claim that the new drug application (NDA) for IONSYS (NDA 21-338) was initially submitted on September 23, 2003. 3. The date the application was approved: May 22, 2006. FDA has verified the applicant's claim that NDA 21-338 was approved on May 22, 2006. 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 5 years 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 [[Page 66664]] 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: September 20, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23330 Filed 9-27-16; 8:45 am] BILLING CODE 4164-01-P
![66662 Federal Register / Vol. 81, No. 188 / Wednesday, September 28, 2016 / Notices
providers. Most recently, CDC HIV prevention science; how providers All data collections will be conducted
published guidelines for health care use guidance or evidence-based only one time. Respondents who will
providers on pre-exposure prophylaxis approaches in their practices generally participate in these interviews will be
(PrEP) and recommendations for HIV as well with populations that have been selected purposively to inform the
prevention with adults and adolescents largely overlooked (e.g., transgender development of appropriate messaging
with HIV. Despite clear and compelling individuals); and how to develop new and materials for healthcare providers.
guidance from CDC, past studies have or enrich existing provider materials to Topic areas addressed within the
shown that patient-provider make them more informative, appealing, interviews may include HIV prevention,
communication about HIV testing and and usable. HIV treatment, and linkage and referral
prevention is uncommon and The three-year study proposes a series
to services. Data will be securely stored
conversations that do take place tend to of in-depth interviews with 600
healthcare providers (i.e., physicians, on password-protected computers and
be brief.
CDC has developed four social physician assistants, and nurses) in locked file cabinets.
marketing campaigns to support patient- identified by contractor staff and The information gathered through this
provider communication about HIV. professional recruiting firms. Data will data collection will allow CDC to
These campaigns have made great be collected through one-time, hour- develop timely, relevant, clear, and
strides in addressing health care long, individual, in-depth interviews engaging materials that continue to
providers’ information needs, thereby accompanied by a computer-assisted support patient-provider
building their capacity to discuss HIV personal interview (total of 1 hour and communications related to HIV
prevention with their patients. At this 15 minutes per person). We anticipate prevention. Participation of respondents
juncture, particularly with the evolving screening 1,200 individuals to obtain is voluntary, and there is no cost to
HIV prevention landscape, more data 600 individuals who will participate in respondents other than their time.
are needed to deepen our understanding a 1-hour, in-depth interview and
of providers’ interpretation and complete a 15-minute computer-assisted The total estimated annualized
understanding of existing and emergent personal interview (web-based) survey. burden hours are 950.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Type of respondent Form name respondents per response
respondent (in hours)
Health care providers ............. Screener ............................................................................................ 1,200 1 10/60
Web-based survey ............................................................................ 600 1 15/60
Interviews .......................................................................................... 600 1 1
Exploratory guide—Prevention with positives and retention in care 50 1 1
Exploratory guide—Transgender health ........................................... 50 1 1
Exploratory guide—HIV prevention ................................................... 50 1 1
Message testing guide ...................................................................... 150 1 1
Concept testing guide ....................................................................... 150 1 1
Materials testing guide ...................................................................... 150 1 1
Leroy A. Richardson, IONSYS and is publishing this notice of Electronic Submissions
Chief, Information Collection Review Office, that determination as required by law. Submit electronic comments in the
Office of Scientific Integrity, Office of the FDA has made the determination following way:
Associate Director for Science, Office of the because of the submission of an • Federal eRulemaking Portal: http://
Director, Centers for Disease Control and application to the Director of the U.S.
Prevention. www.regulations.gov. Follow the
Patent and Trademark Office (USPTO), instructions for submitting comments.
[FR Doc. 2016–23340 Filed 9–27–16; 8:45 am]
Department of Commerce, for the Comments submitted electronically,
BILLING CODE 4163–18–P extension of a patent which claims that including attachments, to http://
human drug product. www.regulations.gov will be posted to
DEPARTMENT OF HEALTH AND DATES: Anyone with knowledge that any the docket unchanged. Because your
HUMAN SERVICES of the dates as published (in the comment will be made public, you are
SUPPLEMENTARY INFORMATION section) are
solely responsible for ensuring that your
Food and Drug Administration incorrect may submit either electronic comment does not include any
or written comments and ask for a confidential information that you or a
[Docket No. FDA–2007–E–0400] third party may not wish to be posted,
redetermination by November 28, 2016.
Furthermore, any interested person may such as medical information, your or
Determination of Regulatory Review
petition FDA for a determination anyone else’s Social Security number, or
Period for Purposes of Patent
regarding whether the applicant for confidential business information, such
Extension; IONSYS
as a manufacturing process. Please note
mstockstill on DSK3G9T082PROD with NOTICES
extension acted with due diligence
AGENCY: Food and Drug Administration, during the regulatory review period by that if you include your name, contact
HHS. March 27, 2017. See ‘‘Petitions’’ in the information, or other information that
ACTION: Notice. SUPPLEMENTARY INFORMATION section for
identifies you in the body of your
more information. comments, that information will be
SUMMARY: The Food and Drug posted on http://www.regulations.gov.
Administration (FDA) has determined ADDRESSES: You may submit comments • If you want to submit a comment
the regulatory review period for as follows: with confidential information that you
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![66664 Federal Register / Vol. 81, No. 188 / Wednesday, September 28, 2016 / Notices
diligence during the regulatory review proposed project or to obtain a copy of the general public using any of the
period. To meet its burden, the petition the data collection plans and draft commonly used Internet browsers via a
must be timely (see DATES) and contain instruments, email paperwork@hrsa.gov link on the HRSA ‘‘Grants’’ Internet site
sufficient facts to merit an FDA or call the HRSA Information Collection or by keying the RRM URL into their
investigation. (See H. Rept. 857, part 1, Clearance Officer at (301) 443–1984. browser.
98th Cong., 2d sess., pp. 41–42, 1984.) SUPPLEMENTARY INFORMATION: When Need and Proposed Use of the
Petitions should be in the format submitting comments or requesting Information: HRSA uses the RRM to
specified in 21 CFR 10.30. information, please include the collect information from individuals
Submit petitions electronically to information request collection title for who are willing to volunteer as objective
http://www.regulations.gov at Docket reference. review committee participants for the
No. FDA–2013–S–0610. Submit written Information Collection Request Title: Agency’s discretionary and competitive
petitions (two copies are required) to the The Division of Independent Review grant or cooperative agreement funding
Division of Dockets Management (HFA– Grant Reviewer Recruitment Form. opportunities. The RRM provides HRSA
305), Food and Drug Administration, OMB No. 0915–0295—Extension. with an effective search and
5630 Fishers Lane, Rm. 1061, Rockville, Abstract: HRSA’s Division of communication functionality with
MD 20852. Independent Review (DIR) is which to identify and contact qualified
Dated: September 20, 2016. responsible for administering the review potential grant review participants. The
Leslie Kux, of eligible grant applications submitted RRM has an enhanced search and
to HRSA. DIR ensures that the objective reporting capability to help DIR ensure
Associate Commissioner for Policy.
review process is independent, efficient, that HRSA’s review participant pool has
[FR Doc. 2016–23330 Filed 9–27–16; 8:45 am]
effective, economical, and complies the necessary skills and diversity to
BILLING CODE 4164–01–P
with the applicable statutes, regulations, meet the ever-evolving need for
and policies. Applications are reviewed qualified grant review participants.
by subject experts knowledgeable in When DIR identifies an expertise,
DEPARTMENT OF HEALTH AND
health and public health disciplines for demographic need, or any other specific
HUMAN SERVICES
which support is requested. Review needs that are under-represented in the
Health Resources and Services findings are advisory to HRSA programs RRM pool, DIR can recruit specifically
Administration responsible for making award decisions. to address those needs. Expertise is
This request continues a Web-based always the primary determinant in
Agency Information Collection data collection system, the Reviewer selecting potential review participants
Activities: Proposed Collection: Public Recruitment Module (RRM), used to for any grant review and no participant
Comment Request; The Division of gather critical review participant is required to provide demographic
Independent Review Grant Reviewer information. The RRM uses information to join the pool or be
Recruitment Form standardized categories of information selected as a reviewer for any
in drop down menu format for data such competition.
AGENCY: Health Resources and Services as the following: Degree, specialty,
Administration (HRSA), Department of occupation, work setting, and in select Likely Respondents: Individuals with
Health and Human Services. instances affiliations with organizations experience in social, cultural, and
ACTION: Notice. and institutions that serve special health care fields who are
populations. Some program regulations knowledgeable about HRSA’s mission
SUMMARY: In compliance with the and competitive program needs to
requirement for opportunity for public require that application objective review
committees contain consumers of health deliver quality health care to all
comment on proposed data collection Americans.
projects (Section 3506(c)(2)(A) of the services. Other demographic data may
be voluntarily provided by a potential Burden Statement: Burden in this
Paperwork Reduction Act of 1995),
review participant. Defined data context means the time expended by
HRSA announces plans to submit an
elements assist HRSA in finding and persons to generate, maintain, retain,
Information Collection Request (ICR),
selecting expert grant review disclose or provide the information
described below, to the Office of
participants for objective review requested. This includes the time
Management and Budget (OMB). Prior
committees. needed to review instructions; to
to submitting the ICR to OMB, HRSA
HRSA maintains a roster of develop, acquire, install and utilize
seeks comments from the public
approximately 6,000 qualified technology and systems for the purpose
regarding the burden estimate, below, or
individuals who served on HRSA of collecting, validating and verifying
any other aspect of the ICR.
objective review committees. The Web- information, processing and
DATES: Comments on this ICR must be
based RRM simplifies review maintaining information, and disclosing
received no later than November 28, participant registration entry using a and providing information; to train
2016. user-friendly Graphical User Interface personnel and to be able to respond to
ADDRESSES: Submit your comments to (GUI) with a few data drop down menu a collection of information; to search
paperwork@hrsa.gov or mail the HRSA choices and a search engine that data sources; to complete and review
Information Collection Clearance supports key word queries in the actual the collection of information; and to
Officer, Room 14N–29, 5600 Fishers resume or Curriculum Vitae text. transmit or otherwise disclose the
Lane, Rockville, MD 20857. Review participants can also update information. The total annual burden
mstockstill on DSK3G9T082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: To their information electronically. The hours estimated for this ICR are
request more information on the RRM is 508 compliant and accessible by summarized in the table below.
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Document Created: 2016-09-28 01:07:22
Document Modified: 2016-09-28 01:07:22
| 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by November 28, 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 March 27, 2017. 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 66662 |
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