82 FR 2381 - Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 5 (January 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 5 (January 9, 2017)
| Page Range | 2381-2383 | |
| FR Document | 2017-00081 |
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)] [Notices] [Pages 2381-2383] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00081] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-4508] Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information and comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is seeking information and public comment, in anticipation of the passage of Generic Drug User Fee Amendments reauthorization (GDUFA II), relevant to FDA's planned approach for administering generic drug program fees under that legislation for fiscal year (FY) 2018. This includes requests for comment and information regarding FDA's initial inventory of approved abbreviated new drug application sponsors and application numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA program fees in a timely manner. DATES: Submit written or electronic comments and information by March 10, 2017. ADDRESSES: You may submit comments as follows: [[Page 2382]] 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 No. FDA-2016-N-4508 for ``Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comment.'' 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: Kristan Callahan, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7900, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In anticipation of the enactment and implementation of GDUFA II, FDA has begun taking steps to ensure efficient administration of GDUFA for FY 2018. It is projected that the GDUFA II legislation will include an annual program fee for which holders of approved abbreviated new drug applications (ANDAs) will be responsible. Under GDUFA II, it is anticipated that affiliated companies will be grouped together and counted as a single entity for purposes of assessing the program fee. The proposed legislation defines the term ``affiliate'' in the same way it was defined in GDUFA. An ``affiliate'' is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has the power to control, both of the business entities. As set forth in the proposed legislation, the program fee will be allocated among three tiers of application holders: Large (companies with 20 or more approved ANDAs); Medium (companies with between 6 and 19 approved ANDAs); and, Small (companies with 5 or fewer approved ANDAs). To assess program fees in an accurate and timely manner if these provisions are enacted, FDA seeks to identify how many approved ANDAs belong to each application holder, and which application holders are affiliates for purposes of assessing GDUFA II program fees. In furtherance of this effort, FDA requests comments and information regarding FDA's initial inventory of approved ANDA sponsors and application numbers. The current spreadsheet containing this initial inventory and instructions on how to use it are available at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm. II. Request for Information and Comment FDA is seeking information and public comment, in anticipation of the passage of GDUFA II, relevant to FDA's planned approach for administering generic drug program fees under that legislation for FY 2018. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner. Interested persons are invited to comment, in general, on any aspect of FDA's planned approach for administering these generic drug program fees under GDUFA II. FDA is particularly interested in comments and information addressing the accuracy and completeness of the information in the previously mentioned spreadsheet containing FDA's initial inventory of approved ANDA sponsors and application numbers. In addition, FDA is interested in any information that could be relevant to determining whether two or more companies that are currently listed separately in that spreadsheet should be considered to be affiliated for purposes of assessing the anticipated program fee. As a general matter, FDA does not consider affiliates [[Page 2383]] to be confidential commercial information. After receiving feedback and comments on the spreadsheet, FDA anticipates publishing a Federal Register notice and making available a revised spreadsheet that will incorporate information received in the comments on this notice. FDA plans to seek comment on the revised spreadsheet before compiling the final information regarding affiliated entities that will be used as the basis for determining and assessing FY 2018 program fees in the event that GDUFA II is enacted. Dated: January 3, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00081 Filed 1-6-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2381
the information at: http://www.fda.gov/ combination with lenalidomide and (see DATES). Furthermore, any interested
regulatoryinformation/dockets/ dexamethasone for the treatment of person may petition FDA for a
default.htm. patients with multiple myeloma who determination regarding whether the
Docket: For access to the docket to have received one to three prior applicant for extension acted with due
read background documents or the therapies. Subsequent to this approval, diligence during the regulatory review
electronic and written/paper comments the USPTO received a patent term period. To meet its burden, the petition
received, go to https:// restoration application for EMPLICITI must be timely (see DATES) and contain
www.regulations.gov and insert the (U.S. Patent No. 7,709,610) from AbbVie sufficient facts to merit an FDA
docket number, found in brackets in the Biotherapeutics, Inc., and the USPTO investigation. (See H. Rept. 857, part 1,
heading of this document, into the requested FDA’s assistance in 98th Cong., 2d sess., pp. 41–42, 1984.)
‘‘Search’’ box and follow the prompts determining this patent’s eligibility for Petitions should be in the format
and/or go to the Division of Dockets patent term restoration. In a letter dated specified in 21 CFR 10.30.
Management, 5630 Fishers Lane, Rm. July 12, 2016, FDA advised the USPTO Submit petitions electronically to
1061, Rockville, MD 20852. that this human biological product had https://www.regulations.gov at Docket
FOR FURTHER INFORMATION CONTACT: undergone a regulatory review period No. FDA–2013–S–0610. Submit written
Beverly Friedman, Office of Regulatory and that the approval of EMPLICITI petitions (two copies are required) to the
Policy, Food and Drug Administration, represented the first permitted Division of Dockets Management (HFA–
10903 New Hampshire Ave., Bldg. 51, commercial marketing or use of the 305), Food and Drug Administration,
Rm. 6250, Silver Spring, MD 20993, product. Thereafter, the USPTO 5630 Fishers Lane, Rm. 1061, Rockville,
301–796–3600. requested that FDA determine the MD 20852.
SUPPLEMENTARY INFORMATION:
product’s regulatory review period. Dated: December 30, 2016.
I. Background II. Determination of Regulatory Review Leslie Kux,
Period Associate Commissioner for Policy.
The Drug Price Competition and
FDA has determined that the [FR Doc. 2017–00108 Filed 1–6–17; 8:45 am]
Patent Term Restoration Act of 1984
applicable regulatory review period for BILLING CODE 4164–01–P
(Pub. L. 98–417) and the Generic
EMPLICITI is 3,400 days. Of this time,
Animal Drug and Patent Term
3,245 days occurred during the testing
Restoration Act (Pub. L. 100–670) DEPARTMENT OF HEALTH AND
phase of the regulatory review period,
generally provide that a patent may be HUMAN SERVICES
while 155 days occurred during the
extended for a period of up to 5 years
approval phase. These periods of time
so long as the patented item (human Food and Drug Administration
were derived from the following dates:
drug product, animal drug product, 1. The date an exemption under
medical device, food additive, or color section 505(i) of the Federal Food, Drug, [Docket No. FDA–2016–N–4508]
additive) was subject to regulatory and Cosmetic Act (21 U.S.C. 355(i))
review by FDA before the item was became effective: August 11, 2006. FDA Generic Drug User Fee Amendments II
marketed. Under these acts, a product’s has verified the applicant’s claim that Program Fee: List of Abbreviated New
regulatory review period forms the basis the date the investigational new drug Drug Application Sponsors and
for determining the amount of extension application became effective was on Application Numbers; Request for
an applicant may receive. August 11, 2006. Information and Comments
A regulatory review period consists of 2. The date the application was
two periods of time: A testing phase and AGENCY: Food and Drug Administration,
initially submitted with respect to the HHS.
an approval phase. For human human biological product under section
biological products, the testing phase ACTION:Notice; request for information
351 of the Public Health Service Act (42
begins when the exemption to permit and comments.
U.S.C. 262): June 29, 2015. FDA has
the clinical investigations of the verified the applicant’s claim that the
biological becomes effective and runs SUMMARY: The Food and Drug
biologics license application (BLA) for Administration (FDA) is seeking
until the approval phase begins. The EMPLICITI (BLA 761035) was initially
approval phase starts with the initial information and public comment, in
submitted on June 29, 2015. anticipation of the passage of Generic
submission of an application to market 3. The date the application was
the human biological product and Drug User Fee Amendments
approved: November 30, 2015. FDA has reauthorization (GDUFA II), relevant to
continues until FDA grants permission verified the applicant’s claim that BLA
to market the biological product. FDA’s planned approach for
761035 was approved on November 30, administering generic drug program fees
Although only a portion of a regulatory 2015.
review period may count toward the under that legislation for fiscal year (FY)
This determination of the regulatory 2018. This includes requests for
actual amount of extension that the review period establishes the maximum
Director of USPTO may award (for comment and information regarding
potential length of a patent extension. FDA’s initial inventory of approved
example, half the testing phase must be However, the USPTO applies several
subtracted as well as any time that may abbreviated new drug application
statutory limitations in its calculations sponsors and application numbers. The
have occurred before the patent was of the actual period for patent extension.
issued), FDA’s determination of the information gathered from public
In its application for patent extension, comments will assist FDA in accurately
length of a regulatory review period for
sradovich on DSK3GMQ082PROD with NOTICES
this applicant seeks 1,095 days of patent assessing FY 2018 GDUFA program fees
a human biological product will include term extension.
all of the testing phase and approval in a timely manner.
phase as specified in 35 U.S.C. III. Petitions DATES: Submit written or electronic
156(g)(1)(B). Anyone with knowledge that any of comments and information by March
FDA has approved for marketing the the dates as published are incorrect may 10, 2017.
human biologic product EMPLICITI submit either electronic or written ADDRESSES: You may submit comments
(elotuzumab). EMPLICITI is indicated in comments and ask for a redetermination as follows:
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![Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2383
to be confidential commercial FOR FURTHER INFORMATION CONTACT: To Need and Proposed Use of the
information. request a copy of the clearance requests Information: HRSA will use this
After receiving feedback and submitted to OMB for review, email the information in determining the
comments on the spreadsheet, FDA HRSA Information Collection Clearance eligibility for the statutory funding
anticipates publishing a Federal Officer at paperwork@hrsa.gov or call preference and special consideration,
Register notice and making available a (301) 443–1984. and to succinctly capture data for the
revised spreadsheet that will number of projected students for
SUPPLEMENTARY INFORMATION:
incorporate information received in the subsequent years in the project period.
comments on this notice. FDA plans to Information Collection Request Title: Likely Respondents: Likely
seek comment on the revised Advanced Education Nursing respondents are potential applicants for
spreadsheet before compiling the final Traineeship (AENT) Program Specific the ANEW program. Eligible applicants
information regarding affiliated entities Data Collection Forms for Use with the for the ANEW program include entities
that will be used as the basis for New Advanced Nursing Education that provide registered nurses with
determining and assessing FY 2018 Workforce (ANEW) Program. primary care NP, primary CNS, and
program fees in the event that GDUFA nurse-midwife education. Such
II is enacted. OMB No. 0915–0375—Revision
programs may include accredited
Dated: January 3, 2017. Abstract: The Advanced Nursing schools of nursing, nursing centers,
Leslie Kux, Education Workforce (ANEW) Program academic health centers, state or local
Associate Commissioner for Policy. is a new program that incorporates governments, and other public or
[FR Doc. 2017–00081 Filed 1–6–17; 8:45 am] elements of HRSA’s Advanced private nonprofit entities authorized by
BILLING CODE 4164–01–P Education Nursing Traineeship (AENT) the Secretary of HHS to confer degrees
and Advanced Nursing Education (ANE) to registered nurses for primary care NP,
programs. The current OMB approved primary care CNS, or nurse-midwife
DEPARTMENT OF HEALTH AND Program Specific Data Collection Forms education. Federally recognized Indian
HUMAN SERVICES for the former AENT Program will be Tribal Government and Native
simplified and used for the ANEW American Organizations as well as faith-
Health Resources and Services program. HRSA provides advanced based or community-based
Administration education nursing grants to educational organizations may apply if they are
institutions to increase the numbers of otherwise eligible.
Agency Information Collection Eligible state government entities
advanced education nurses through the
Activities: Submission to OMB for include the 50 states, the District of
ANEW Program. The ANEW Program is
Review and Approval; Public Comment Columbia, Guam, the Commonwealth of
authorized by Title VIII, Section 811 of
Request; Advanced Education Nursing Puerto Rico, the Northern Mariana
the Public Health Service Act (42 U.S.C.
Traineeship (AENT) Program Specific Islands, American Samoa, the U.S.
296j). This renewal with revision
Data Collection Forms Virgin Islands, the Federated States of
request includes the Project Abstract,
AGENCY: Health Resources and Services Program Narrative, Attachments, and Micronesia, the Republic of the
Administration (HRSA), Department of Tables. The proposed ANEW Tables are Marshall Islands, and the Republic of
Health and Human Services. very similar to the previous AENT Palau.
ACTION: Notice. Tables and include information on Burden Statement: Burden in this
program participants such as the context means the time expended by
SUMMARY: In compliance with the projected number of enrollees/trainees persons to generate, maintain, retain,
requirement for opportunity for public receiving traineeship support; projected disclose, or provide the information
comment on proposed data collection number of graduates receiving requested. This includes the time
projects of the Paperwork Reduction Act traineeship support for the previous needed to review instructions; to
of 1995, HRSA has submitted an fiscal year; the types of programs they develop, acquire, install, and utilize
Information Collection Request (ICR) to are enrolling into and/or from which technology and systems for the purpose
the Office of Management and Budget enrollees/trainees are graduating, and of collecting, validating and verifying
(OMB) for review and approval. the distribution of primary care nurse information, processing and
Comments submitted during the first practitioners (NP), primary care clinical maintaining information, and disclosing
public review of this ICR will be nurse specialists (CNS); and nurse- and providing information; to train
provided to OMB. OMB will accept midwives who plan to practice in rural personnel and be able to respond to a
further comments from the public and underserved settings. To reduce the collection of information; to search data
during the review and approval period. reporting burden for applicants, HRSA sources; to complete and review the
DATES: Comments on this ICR should be simplified the Tables to focus on the collection of information; and to
received no later than February 8, 2017. types of providers and practice settings transmit or otherwise disclose the
ADDRESSES: Submit your comments, that are included in the statute in order information. The total annual burden
including the ICR Title, to the desk to determine whether applicants qualify hours estimated for this ICR are
officer for HRSA, either by email to for the preference or special summarized in the table below.
OIRA_submission@omb.eop.gov or by consideration in making awards for this Total estimated annualized burden
fax to 202–395–5806. program. hours:
sradovich on DSK3GMQ082PROD with NOTICES
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
ANEW Application including the ANEW Program Specific
Tables and Attachments .................................................. 236 1 236 7 1,652
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Document Created: 2018-10-24 11:10:42
Document Modified: 2018-10-24 11:10:42
| 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; request for information and comments. | |
| Dates | Submit written or electronic comments and information by March 10, 2017. | |
| Contact | Kristan Callahan, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7900, [email protected] | |
| FR Citation | 82 FR 2381 |
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