81 FR 54097 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 157 (August 15, 2016)

Page Range		54097-54099
FR Document		2016-19385

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

Federal Register, Volume 81 Issue 157 (Monday, August 15, 2016)

[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54097-54099]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-19385]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0662]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Applications for Food
and Drug Administration Approval To Market a New Drug: Patent
Submission and Listing Requirements and Application of 30-Month Stays
on Approval of Abbreviated New Drug Applications Certifying That a
Patent Claiming a Drug Is Valid or Will Not Be Infringed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
September 14, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0513.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 8455
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

[[Page 54098]]

Applications for FDA Approval To Market a New Drug: Patent Submission
and Listing Requirements and Application of 30-Month Stays on Approval
of Abbreviated New Drug Applications Certifying That a Patent Claiming
a Drug Is Invalid or Will Not Be Infringed OMB Control Number 0910-
0513--Extension

Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(b)(1)) requires all new drug application (NDA)
applicants to file, as part of the NDA, ``the patent number and the
expiration date of any patent which claims the drug for which the
applicant submitted the application or which claims a method of using
such drug and with respect to which a claim of patent infringement
could reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug.'' Under section
505(b)(1), we publish the patent information after approval of the NDA
in the list entitled ``Approved Drug Products with Therapeutic
Equivalence Evaluations'' (the Orange Book). Section 505(c)(2) of the
FD&C Act (21 U.S.C. 355(c)(2)) imposes a similar patent submission
obligation on holders of approved NDAs that requires patent information
be submitted after NDA approval when the NDA holder could not have
submitted the patent information with its application. Under section
505(c)(2) of the FD&C Act, we publish the patent information upon its
submission.
FDA regulations at Sec. 314.50(h) and Sec. 314.53 (21 CFR
314.50(h) and 314.53) implement these statutory requirements and
clarify the types of patent information that must and must not be
submitted to FDA as part of an NDA, an amendment, or a supplement. The
regulations under Sec. 314.53 direct sponsors of an NDA, an amendment,
or a supplement, to make detailed patent declarations using Forms FDA
3542 and 3542a as appropriate. While the information collection burden
for submitting other required elements of an NDA, an amendment, or
supplement in accordance with Sec. 314.50(a) through (f), and (k) is
approved under OMB control number 0910-0001, this information
collection identifies burden associated with patent submission and
listing, as explained below.
Specifically, a patent declaration is required for each ``patent
that claims the drug or a method of using the drug that is the subject
of the new drug application or amendment or supplement to it and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner of the patent engaged in
the manufacture, use, or sale of the drug product'' (Sec. 314.53(b)).
Such patents claim the drug substance (active ingredient), drug product
(formulation and composition), or method of use. Within 30 days after
the date of approval of an application, the applicant must submit Form
FDA 3542 for each patent that claims the drug substance (active
ingredient), drug product (formulation and composition), or approved
method of use for listing in the Orange Book. In addition, for patents
issued after the date of approval of an application, Form FDA 3542 must
be submitted within 30 days of the date of issuance of the patent. If a
patent is issued after the application is filed with FDA, but before
the application is approved, the applicant must submit the required
patent information on Form FDA 3542a as an amendment to the
application, within 30 days of the date of issuance of the patent.
Description of Respondents: The respondents to this collection of
information are sponsors of an NDA, an amendment, or a supplement, or
submitting information on a patent after NDA approval.
In the Federal Register of February 2, 2016 (81 FR 5465), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. One comment was received
but was not responsive to the four collection of information topics
solicited and is therefore not addressed.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR 314.50 and 314.53 Number of responses per Total annual Burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Form FDA 3542; patent 200 3.4 680 5 3,400
information submitted upon and
after approval of an NDA or
supplement.....................
Form FDA 3542a; patent 241 3.4 819 20 16,380
information submitted with the
filing of an NDA, amendment, or
supplement.....................
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Total....................... .............. .............. .............. .............. 19,780
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The number of patents submitted to FDA for listing in the Orange
Book in 2012, 2013, and 2014 were 458, 509, and 617, respectively, for
an annual average of 528 patents ([458 + 509 + 617]/3 years = 528).
Because many of these individual patents are included in multiple NDA
submissions, there may be multiple declarations for a single patent.
From our review of submissions, we believe that approximately 14
percent of the patents submitted are included in multiple NDA
submissions and thus require multiple patent declarations. Therefore,
we estimate that 74 patents (528 x 14 percent) will be multiple
listings for a total of 602 patents (528 + 74 = 602) as declared on
Form FDA 3542. We approved 86, 94, and 107 NDAs in calendar years 2012,
2013, and 2014, respectively, of which we estimate 71 percent submitted
patent information for listing in the Orange Book. The remaining Form
FDA 3542 submissions declared that there were no relevant patents.
We also approved approximately 101, 101, and 110 NDA supplements in
FYs 2012, 2013, and 2014, respectively, for which submission of a
patent declaration would be required. Based on an average of 96 NDA
approvals and 104 supplement approvals annually, we estimate there will
be 200 instances where an NDA holder would be affected by the patent
declaration requirements, and that each of these NDA holders would, on
average, submit 3.4 declarations (602 patent declarations + 74 no
relevant patent declarations)/200 instances = 3.4 declarations per
instance) on Form FDA 3542. We filed 112, 116, and 113 NDAs in 2012,
2013, and 2014, respectively, and 112, 112, 156 NDA supplements in
2012, 2013, and 2014, respectively, for which submission of a patent
declaration would be required. Based upon informal communications with
industry and our experience with the collection, we

[[Page 54099]]

estimate it will take 5 hours to complete Form FDA 3542.
We estimate there will be 241 instances (based on an average of 114
NDAs filed and 127 NDA supplements filed per year) where an NDA holder
would comply with the patent declaration requirements. We estimate,
based on a proportional increase from the number of declarations for
approved NDAs, that there will be an annual total of 819 such
declarations (241 x 3.4 declarations per instance = 819). Based upon
informal communications with industry and our experience with the
collection, we estimate it will take 20 hours to complete Form FDA
3542a.

Dated: August 5, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19385 Filed 8-12-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices 54097

related to the HPOG 2.0 National representatives of partner agencies and staff; administrative staff at grantee
Evaluation in the future. A Federal stakeholders, including support service institutions; representatives from
Register Notice will be published, providers, education and vocational partner agencies and stakeholders,
allowing for public comment prior to training providers, Workforce including local employers; and Tribal
submitting the proposed ICR to OMB. Investment Boards, TANF agencies, and HPOG program participants at the 5
Respondents: For the HPOG 2.0 participants at the 27 non-tribal HPOG tribal HPOG 2.0 grantees.
National Evaluation: HPOG program 2.0 grantees. For the HPOG 2.0 Tribal This information collection request is
managers; HPOG program staff; and Evaluation: Tribal HPOG 2.0 program for 3 years.

ANNUAL BURDEN ESTIMATES
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response

HPOG 2.0 National Evaluation

1. Screening tool for identifying respondents for first-round
telephone interviews ......................................................... 114 38 1 .5 19
2. First round telephone interview protocol for non-tribal
HPOG grantee staff and partners .................................... 570 190 1 .75 143
3. On-site interviews with program management, staff and
major partners at six programs ........................................ 216 72 1 1.5 108
4. Participant contact update forms ..................................... 15,000 5000 4 .1 2000

HPOG 2.0 Tribal Evaluation

5. Grantee and partner administrative staff interview ......... 105 35 1 1 35
6. Program implementation staff interview .......................... 150 50 1 1.5 75
7. Employer interview .......................................................... 90 30 1 .75 23
8. Program participant focus group ..................................... 405 135 1 1.5 203
9. Program participant completer interview ......................... 300 100 1 1 100
10. Program participant non-completer interview ................ 150 50 1 1 50

Estimated Total Annual Burden of automated collection techniques or SUMMARY: The Food and Drug
Hours: 2756. other forms of information technology. Administration (FDA or we) is
In compliance with the requirements Consideration will be given to announcing that a proposed collection
of Section 3506(c)(2)(A) of the comments and suggestions submitted of information has been submitted to the
Paperwork Reduction Act of 1995, the within 60 days of this publication. Office of Management and Budget
Administration for Children and (OMB) for review and clearance under
Robert Sargis,
Families is soliciting public comment the Paperwork Reduction Act of 1995
ACF/OPRE Certifying Officer. (the PRA).
on the specific aspects of the
[FR Doc. 2016–19337 Filed 8–12–16; 8:45 am]
information collection described above. DATES: Fax written comments on the
BILLING CODE 4184–72–P
Copies of the proposed collection of collection of information by September
information can be obtained and 14, 2016.
comments may be forwarded by writing ADDRESSES: To ensure that comments on
DEPARTMENT OF HEALTH AND
to the Administration for Children and the information collection are received,
HUMAN SERVICES
Families, Office of Planning, Research OMB recommends that written
and Evaluation, 330 C Street SW., Food and Drug Administration comments be faxed to the Office of
Washington, DC 20201, Attn: OPRE Information and Regulatory Affairs,
Reports Clearance Officer. Email OMB, Attn: FDA Desk Officer, FAX:
[Docket No. FDA–2013–N–0662]
address: OPREinfocollection@ 202–395–7285, or emailed to oira_
acf.hhs.gov. All requests should be Agency Information Collection submission@omb.eop.gov. All
identified by the title of the information Activities; Submission for Office of comments should be identified with the
collection. Management and Budget Review; OMB control number 0910–0513. Also
The Department specifically requests Comment Request; Applications for include the FDA docket number found
comments on (a) whether the proposed Food and Drug Administration in brackets in the heading of this
collection of information is necessary Approval To Market a New Drug: document.
for the proper performance of the Patent Submission and Listing FOR FURTHER INFORMATION CONTACT:
functions of the agency, including Requirements and Application of 30-
whether the information shall have Food and Drug Administration, 8455
Month Stays on Approval of Colesville Rd., COLE–14526, Silver
practical utility; (b) the accuracy of the
sradovich on DSK3GMQ082PROD with NOTICES

Abbreviated New Drug Applications Spring, MD 20993–0002, PRAStaff@
agency’s estimate of the burden of the Certifying That a Patent Claiming a
proposed collection of information; (c) fda.hhs.gov.
Drug Is Valid or Will Not Be Infringed
the quality, utility, and clarity of the SUPPLEMENTARY INFORMATION: In
information to be collected; and (d) AGENCY: Food and Drug Administration, compliance with 44 U.S.C. 3507, FDA
ways to minimize the burden of the HHS. has submitted the following proposed
collection of information on collection of information to OMB for
ACTION: Notice.
respondents, including through the use review and clearance.

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Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices 54099

estimate it will take 5 hours to complete MD 20910. The hotel’s phone number is Dated: August 8, 2016.
Form FDA 3542. 301–589–0800. Jeremy Sharp,
We estimate there will be 241 FOR FURTHER INFORMATION CONTACT: Lori Deputy Commissioner for Policy, Planning,
instances (based on an average of 114 Benner and/or Jessica Barnes, Center for Legislation and Analysis.
NDAs filed and 127 NDA supplements Drug Evaluation and Research, Food [FR Doc. 2016–19336 Filed 8–12–16; 8:45 am]
filed per year) where an NDA holder and Drug Administration, 10903 New BILLING CODE 4164–01–P
would comply with the patent Hampshire Ave., Bldg. 22, Rm. 6221,
declaration requirements. We estimate, Silver Spring, MD 20993–0002, 301–
based on a proportional increase from 796–1300. DEPARTMENT OF HEALTH AND
the number of declarations for approved HUMAN SERVICES
NDAs, that there will be an annual total SUPPLEMENTARY INFORMATION: FDA is
of 819 such declarations (241 × 3.4 announcing a public workshop Food and Drug Administration
declarations per instance = 819). Based regarding anti-infective drug
[Docket No. FDA–2016–N–0001]
upon informal communications with development for neonates and young
industry and our experience with the infants. Discussions will focus on Allergenic Products Advisory
collection, we estimate it will take 20 challenges related to enrolling neonates Committee; Notice of Meeting
hours to complete Form FDA 3542a. and young infants in clinical trials,
strategies to assess central nervous AGENCY: Food and Drug Administration,
Dated: August 5, 2016. system (CNS) penetration of the drug, HHS.
Jeremy Sharp, including nonclinical and in vitro data, ACTION: Notice.
Deputy Commissioner for Policy, Planning, potential development pathways, and
Legislation, and Analysis. the role of clinical trial networks in anti- SUMMARY: The Food and Drug
[FR Doc. 2016–19385 Filed 8–12–16; 8:45 am] infective drug development in the Administration (FDA) announces a
BILLING CODE 4164–01–P neonatal population. forthcoming public advisory committee
Registration: Registration is free for meeting of the Allergenic Products
the public workshop. Interested parties Advisory Committee. The general
DEPARTMENT OF HEALTH AND are encouraged to register early. Seating function of the committee is to provide
HUMAN SERVICES will be available on a first-come, first- advice and recommendations to the
served basis. To register electronically, Agency on FDA’s regulatory issues. At
Food and Drug Administration least one portion of the meeting will be
email registration information
(including name, title, firm name, closed to the public.
[Docket No. FDA–2016–N–0001] address, telephone, and fax number) to DATES: The meeting will be held on
NeonatalAntibacterialWorkshop2016@ October 27, 2016, from 1 p.m. to 4:20
Facilitating Anti-Infective Drug p.m.
fda.hhs.gov. Persons without access to
Development for Neonates and Young
the Internet can call 301–796–1300 to ADDRESSES: FDA White Oak Campus,
Infants; Notice of Public Workshop
register. 10903 New Hampshire Ave., Building
AGENCY: Food and Drug Administration, If you need special accommodations 31 Conference Center, the Great Room
HHS. due to a disability, please contact Jessica (Rm. 1503), Silver Spring, MD 20993–
ACTION: Notice of public workshop. Barnes or Lori Benner (see FOR FURTHER 0002. Answers to commonly asked
INFORMATION CONTACT) at least 7 days in questions including information
SUMMARY: The Food and Drug advance. regarding special accommodations due
Administration (FDA) is announcing a Agenda: The workshop draft Agenda to a disability, visitor parking, and
public workshop regarding anti- will be made available at: http:// transportation may be accessed at:
infective drug development for neonates www.fda.gov/Drugs/NewsEvents/ http://www.fda.gov/
and young infants. FDA is interested in ucm507958.htm at least 2 days prior to AdvisoryCommittees/
discussing the scientific challenges the meeting. The Agency encourages AboutAdvisoryCommittees/
pertaining to development of anti- individuals, industry, health care ucm408555.htm.
infective products for neonates and professionals, researchers, public health FOR FURTHER INFORMATION CONTACT:
young infants. This public workshop is organizations and other interested Janie Kim or Denise Royster, Center for
intended to provide information for and persons to attend this public workshop. Biologics Evaluation and Research,
gain perspective from health care Transcripts: Please be advised that as Food and Drug Administration, 10903
providers, other U.S. Government soon as a transcript is available, it will New Hampshire Ave., Bldg. 71, Silver
Agencies, public health organizations, be accessible at http:// Spring, MD 20993–0002, 301–796–9016
academic experts, and industry on www.regulations.gov. It may be viewed or 240–402–8158, email: Janie.Kim@
various aspects of drug development for at the Division of Dockets Management fda.hhs.gov or Denise.Royster@
new and currently marketed anti- (HFA–305), Food and Drug fda.hhs.gov, or FDA Advisory
infective drugs for neonates and young Administration, 5630 Fishers Lane, Rm. Committee Information Line, 1–800–
infants. The input from this public 1061, Rockville, MD 20852. A transcript 741–8138 (301–443–0572 in the
workshop will also help in developing will also be available in either hardcopy Washington, DC area). A notice in the
topics for future discussion. or on CD–ROM, after submission of a Federal Register about last minute
DATES: The public workshop will be Freedom of Information request. The modifications that impact a previously
sradovich on DSK3GMQ082PROD with NOTICES

held on September 15, 2016, from 8:30 Freedom of Information office address is announced advisory committee meeting
a.m. to 4:30 p.m. See the available on the Agency’s Web site at cannot always be published quickly
SUPPLEMENTARY INFORMATION section for http://www.fda.gov. Transcripts will enough to provide timely notice.
registration information. also be available on the Internet at: Therefore, you should always check the
ADDRESSES: The public workshop will http://www.fda.gov/Drugs/NewsEvents/ Agency’s Web site at http://
be held at the Sheraton Silver Spring ucm507958.htm approximately 45 days www.fda.gov/AdvisoryCommittees/
Hotel, 8777 Georgia Ave., Silver Spring, after the workshop. default.htm and scroll down to the

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Document Created: 2016-08-13 02:21:49
Document Modified: 2016-08-13 02:21:49

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		Fax written comments on the collection of information by September 14, 2016.
Contact		Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 54097

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 157 (August 15, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration