82_FR_58640 82 FR 58403 - 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

82 FR 58403 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 237 (December 12, 2017)

Page Range58403-58407
FR Document2017-26670

The Food and Drug Administration (FDA) 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.

Federal Register, Volume 82 Issue 237 (Tuesday, December 12, 2017) 
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58403-58407]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26670]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0523]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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.

DATES: Fax written comments on the collection of information by January 
11, 2018.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0001. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

Application for FDA Approval To Market a New Drug

OMB Control Number 0910-0001--Extension

    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially 
marketed in the United States, imported, or exported from the United 
States, unless an approval of an application filed with FDA under 
section 505(b) or (j) of the FD&C Act is effective with respect to such 
drug. The Agency has codified regulations regarding applications for 
FDA approval to market a new drug under 21 CFR part 314. This 
collection of information supports the regulatory requirements found in 
those regulations. The collection of information is necessary for FDA 
to make a scientific and technical determination whether the product is 
safe and effective for use, and is summarized as follows:
    Section 314.50(a) requires that an application form (Form FDA 356h) 
be submitted that includes information about the applicant, the 
submission, and a checklist of enclosures.
    Section 314.50(b) requires that an index be submitted with the 
archival copy of the application and that it reference certain sections 
of the application.
    Section 314.50(c) requires that a summary of the application be 
submitted that presents a good general synopsis of all the technical 
sections and other information in the application.
    Section 314.50(d) requires that the new drug application (NDA) 
contain the following technical sections about the new drug: Chemistry, 
manufacturing,

[[Page 58404]]

and controls; nonclinical pharmacology and toxicology; human 
pharmacokinetics and bioavailability; microbiology; clinical data; 
statistical; and pediatric use sections.
    Section 314.50(e) requires the applicant to submit samples of the 
drug if requested by FDA. In addition, the archival copy of the 
application must include copies of the label and all labeling for the 
drug.
    Section 314.50(f) requires that case report forms and tabulations 
be submitted with the archival copy.
    Section 314.50(h) requires that patent information, as described 
under Sec.  [thinsp]314.53, be submitted with the application. However, 
burden hours for Sec.  [thinsp]314.50(h) are approved under OMB control 
numbers 0910-0513 (Patent Certification Forms FDA 3542 and FDA 3542a) 
and 0910-0786 (Abbreviated New Drug Applications (ANDAs) and 505(b)(2) 
Applications), and are therefore not included among the estimates found 
in table 1.
    Section 314.50(i) requires that patent certification information be 
submitted in section 505(b)(2) applications for patents claiming the 
drug substance, drug product, or method of use. Sections 
314.50(i)(1)(i)(C) and 314.54(i) and (j) require that patent 
certification information be submitted for each patent listed in the 
``Approved Drug Products with Therapeutic Equivalence Evaluations'' 
(the Orange Book) for a drug product approved in an NDA that is 
pharmaceutically equivalent to the proposed drug product in the 
original 505(b)(2) application and was submitted and was approved 
before the original 505(b)(2) application was submitted. Burden for 
these provisions is included under OMB control number 0910-0786.
    Section 314.50(j) requires that applicants who request a period of 
marketing exclusivity submit certain information with the application.
    Section 314.50(k) requires that the application contain a financial 
certification or disclosure statement or both.
    Section 314.50(l) requires that an archival, review, and field copy 
of the application be submitted, including the content of labeling and 
all labeling and labels.
    Section 314.52 requires that any notice of certification of 
invalidity, unenforceability, or non-infringement of a patent to each 
patent owner and the NDA holder be sent by a section 505(b)(2) 
applicant that relies on a listed drug. A 505(b)(2) applicant is 
required to amend the application at the time notice is provided to 
include a statement certifying that the required notice has been 
provided. A 505(b)(2) applicant also is required to amend the 
application to document receipt of the required notice. Burden hours 
for these provisions are included in OMB control number 0910-0786.
    Section 314.53 sets forth the patent information requirements for 
applicants who submit applications or amendments to the application 
filed under section 505(b)(2) of the FD&C Act or supplements to the 
approved 505(b)(2) application. Burden hours for these collections are 
approved in OMB control number 0910-0786.
    Section 314.54 sets forth the content requirements for applications 
filed under section 505(b)(2) of the FD&C Act. The burden estimate for 
505(b)(2) applications is included in table 1 under the estimates for 
Sec.  314.50(a) through (g) and (i) through (l).
    Section 314.55 sets forth the assessment requirements for each 
application. The burden estimate for 505(b)(2) applications is included 
in table 1 under the estimates for Sec.  314.50(a) through (g) and (i) 
through (l).
    Section 314.60 sets forth reporting requirements and patent 
certification requirements for sponsors who amend an unapproved 
505(b)(2) application. Burden hours for the Sec.  314.60(f) collections 
are approved under OMB control number 0910-0786.
    Section 314.65 states that the sponsor must notify FDA when 
withdrawing an unapproved application.
    Sections 314.70 and 314.71 require that supplements be submitted to 
FDA for certain changes to an approved application.
    Section 314.72 requires sponsors to report to FDA any transfer of 
ownership of an application.
    Section 314.80(c)(1) and (2) set forth requirements for expedited 
adverse drug experience postmarketing reports and followup reports, as 
well as for periodic adverse drug experience postmarketing reports 
(Form FDA 3500A).
    Section 314.80(i) establishes recordkeeping requirements for 
reports of postmarketing adverse drug experiences. The burden hours for 
Sec.  314.80(i) are approved under OMB control numbers 0910-0230 
(Adverse Drug Experience Reporting) and 0910-0291 (MedWatch: FDA's 
Medical Reporting Program), and therefore burden estimates are not 
included in table 1.
    Section 314.81(b)(1) requires that NDA and ANDA field alert reports 
be submitted to FDA (Forms FDA 3331 and Form FDA 3331a).
    Section 314.81(b)(2) requires that annual reports be submitted to 
FDA (Form FDA 2252).
    Section 314.81(b)(3)(i) requires that drug advertisements and 
promotional labeling be submitted to FDA (Form FDA 2253).
    Section 314.81(b)(3)(iii) sets forth reporting requirements for 
sponsors who withdraw an approved drug product from sale. The burden 
hours for Sec.  314.81(b)(3)(iii) are approved under OMB control number 
0910-0045 (Registration of Producers of Drugs and Listing of Drugs in 
Commercial Distribution), and therefore are not included in table 1.
    Section 314.90 sets forth requirements for sponsors who request 
waivers from FDA for compliance with Sec. Sec.  314.50 through 314.81. 
The information collection burden estimate for NDA waiver requests is 
included in table 1 under the estimates for each section that is in 
part 314, subpart B.
    Section 314.93 sets forth requirements for submitting a suitability 
petition to request a change from a listed drug in accordance with 
Sec.  10.20 (21 CFR 10.20) and Sec.  10.30. The burden hours for Sec.  
314.93 are approved under OMB control number 0910-0191 (Administrative 
Practices and Procedures; Formal Evidentiary Public Hearing) and are 
not included in table 1.
    Section 314.94(a) through (d) require that an ANDA contain the 
following information: Application form; table of contents; basis for 
ANDA submission; conditions of use; active ingredients; route of 
administration, dosage form, and strength; bioequivalence; labeling; 
chemistry, manufacturing, and controls; samples; and patent 
certification.
    Section 314.95 requires that any notice of certification of 
invalidity or non-infringement of a patent to each patent owner and the 
NDA holder be sent by ANDA applicants.
    Section 314.96 sets forth requirements for amendments to an 
unapproved ANDA.
    Section 314.97 sets forth requirements for submitting supplements 
to an approved ANDA for certain changes to the application. Approval of 
burden hours for information collections for Sec. Sec.  314.95 through 
314.97 are covered under OMB control number 0910-0786.
    Section 314.98(a) sets forth postmarketing adverse drug experience 
reporting and recordkeeping requirements for ANDAs. The burden hours 
for Sec.  314.98(a) are approved under OMB control numbers 0910-0230 
and 0910-0291 and are not included in table 1 of this document.
    Section 314.98(b) requires other postmarketing reports for ANDAs: 
Field alert reports (Form FDA 3331a), annual reports (Form FDA 2252), 
and

[[Page 58405]]

advertisements and promotional labeling (Form FDA 2253). (The 
information collection burden estimate for field alert reports is 
included in table 1 of this document under Sec.  314.81(b)(1); the 
estimate for annual reports is included under Sec.  314.81(b)(2); the 
estimate for advertisements and promotional labeling is included under 
Sec.  314.81(b)(3)(i).)
    Section 314.99(a) requires that sponsors comply with certain 
reporting requirements for withdrawing an unapproved ANDA and for a 
change in ownership of an ANDA.
    Section 314.99(b) sets forth requirements for sponsors who request 
waivers from FDA for compliance with Sec. Sec.  314.92 through 314.99. 
(The information collection burden estimate for ANDA waiver requests is 
included in table 1 of this document under the estimates for each 
section that is in part 314, subpart C.)
    Section 314.101(a) states that if FDA refuses to file an 
application, the applicant may request an informal conference with FDA 
and request that the application be filed over protest.
    Section 314.102 covers communications between FDA and applicants, 
including requests for meetings.
    Section 314.103 covers specified dispute resolution. To assist 
respondents with certain aspects of this requirement, we have issued 
draft guidance entitled ``Requests for Reconsideration at the Division 
Level Under GDUFA [the Generic Drug User Fee Act]; Guidance for 
Industry.''
    Section 314.107(c) requires notice to FDA by the first applicant to 
submit a substantially complete ANDA containing a certification that a 
relevant patent is invalid, unenforceable, or will not be infringed of 
the date of first commercial marketing. The burden estimate for Sec.  
314.107(c) is included in table 1 under the estimates for Sec.  
314.50(a) through (g) and (i) through (l).
    Section 314.107(e) requires that an applicant submit a copy of the 
entry of the order or judgment to FDA within 10 working days of a final 
judgment. The burden estimate for Sec.  314.107(e) applications is 
included in table 1 under the estimates for Sec.  314.50(a) through (g) 
and (i) through (l) and is approved under OMB control number 0910-0786.
    Section 314.107(f) requires that ANDA or section 505(b)(2) 
applicants notify FDA immediately of the filing of any legal action 
filed within 45 days of receipt of the notice of certification. A 
patent owner must also notify FDA of the filing of any legal action for 
patent infringement. If the patent owner or approved application holder 
who is an exclusive patent licensee waives its opportunity to file a 
legal action for patent infringement within the 45-day period, the 
patent owner or approved application holder may submit to FDA a waiver 
in the specified format. The burden estimate for Sec.  314.107(f) is 
included in table 1 under the estimates for Sec.  314.50 (a) through 
(g) and (i) through (l) and is approved under OMB control number 0910-
0786.
    Section 314.110(b)(3) states that, after receipt of an FDA complete 
response letter, an applicant must either: (1) Resubmit the application 
addressing all the deficiencies identified in the complete response 
letter; (2) withdraw the application; or (3) request an opportunity for 
a hearing on the question of whether there are grounds for denying 
approval of the application. The burden hours for Sec.  314.110(b)(3) 
are included under parts 10 through 16 (21 CFR parts 10 through 16, OMB 
control number 0910-0191) hearing regulations, in accordance with Sec.  
314.201, and are not included in table 1.
    Section 314.122(a) requires that an ANDA or a suitability petition 
that relies on a listed drug that has been voluntarily withdrawn from 
sale must be accompanied by a petition seeking a determination whether 
the drug was withdrawn for safety or effectiveness reasons. The burden 
hours for Sec.  314.122(a) are approved under OMB control number 0910-
0191 and therefore are not included in table 1.
    Section 314.122(d) sets forth requirements for relisting petitions 
for unlisted discontinued products. The burden hours for Sec.  
314.122(d) are approved under OMB control number 0910-0191 and 
therefore are not included in table 1.
    Sections 314.125 and 314.127 state that FDA may refuse to approve 
an NDA or an ANDA and will provide the applicant written notice of an 
opportunity for a hearing under Sec.  314.200 along with the reason for 
refusal to approve the application, including lack of a patent 
certification or statement with respect to each listed patent for an 
approved drug product that is pharmaceutically equivalent to the drug 
product for which the original 505(b)(2) application is submitted and 
was approved before the original 505(b)(2) was submitted. The burden 
hours for Sec. Sec.  314.125 and 314.127 (refuse to approve an ANDA) 
are included under parts 10 through 16 hearing regulations (in 
accordance with Sec.  314.201) and approved under OMB control number 
0910-0191, and therefore are not included in table 1.
    Section 314.126(c) sets forth requirements for a petition to waive 
criteria for adequate and well-controlled studies. The burden hours for 
Sec.  314.126(c) are approved under OMB control number 0910-0191 and 
therefore are not included in table 1.
    Sections 314.150(a) and (b) and 314.151(a) and (b) set forth 
requirements for the withdrawal of approval of an NDA or ANDA and the 
applicant's opportunity for a hearing and submission of comments. The 
burden hours for Sec.  314.151(a) and (b) are included under parts 10 
through 16 hearing regulations, in accordance with Sec.  314.201, and 
approved under OMB control number 0910-0191 and therefore are not 
included in table 1.
    Section 314.151(c) sets forth the requirements for withdrawal of 
approval of an ANDA and the applicant's opportunity to submit written 
objections and participate in a limited oral hearing. The burden hours 
for Sec.  314.151(c) are included under parts 10 through 16 hearing 
regulations, in accordance with Sec.  314.201, approved under OMB 
control number 0910-0191, and therefore are not included in table 1.
    Section 314.153(b) sets forth the requirements for suspension of an 
ANDA when the listed drug is voluntarily withdrawn for safety and 
effectiveness reasons, and the applicant's opportunity to present 
comments and participate in a limited oral hearing. The burden hours 
for Sec.  314.152(b) are included under parts 10 through 16 hearing 
regulations, in accordance with Sec.  314.201, approved under OMB 
control number 0910-0191, and therefore are not included in table 1.
    Section 314.161(b) and (e) sets forth the requirements for 
submitting a petition to determine whether a listed drug was 
voluntarily withdrawn from sale for safety or effectiveness reasons. 
The burden hours for Sec.  314.161(b) and (e) are approved under OMB 
control number 0910-0191 and therefore are not included in table 1.
    Section 314.200(c), (d), and (e) requires that applicants or others 
subject to a notice of opportunity for a hearing who wish to 
participate in a hearing file a written notice of participation and 
request for a hearing as well as the studies, data, and so forth, 
relied on. Other interested persons may also submit comments on the 
notice. This section also sets forth the content and format 
requirements for the applicants' submission in response to notice of 
opportunity for hearing. The burden hours for Sec.  314.200(c), (d), 
and (e) are included under parts 10 through 16 hearing regulations, in 
accordance with

[[Page 58406]]

Sec.  314.201, are approved under OMB control number 0910-0191, and 
therefore are not included in table 1.
    Section 314.200(f) states that participants in a hearing may make a 
motion to the presiding officer for the inclusion of certain issues in 
the hearing. The burden hours for Sec.  314.200(f) are included under 
parts 10 through 16 hearing regulations, in accordance with Sec.  
314.201, are approved under OMB control number 0910-0191, and therefore 
are not included in table 1.
    Section 314.200(g) states that a person who responds to a proposed 
order from FDA denying a request for a hearing provide sufficient data, 
information, and analysis to demonstrate that there is a genuine and 
substantial issue of fact, which justifies a hearing. The burden hours 
for Sec.  314.200(g) are included under parts 10 through 16 hearing 
regulations, in accordance with Sec.  314.201, are approved under OMB 
control number 0910-0191, and therefore are not included in table 1.
    Section 314.420 states that an applicant may submit to FDA a drug 
master file in support of an application, in accordance with certain 
content and format requirements.
    Section 314.430 states that data and information in an application 
are disclosable under certain conditions, unless the applicant shows 
that extraordinary circumstances exist. The burden hours for Sec.  
314.430 are included under parts 10 through 16 hearing regulations, in 
accordance with Sec.  314.201, are approved under OMB control number 
0910-0191, and therefore are not included in table 1.
    Section 314.530(c) and (e) states that if FDA withdraws approval of 
a drug approved under the accelerated approval procedures, the 
applicant has the opportunity to request a hearing and submit data and 
information. The burden hours for Sec.  314.530(c) and (e) are included 
under parts 10 through 16 hearing regulations, in accordance with Sec.  
314.201, are approved under OMB control number 0910-0191, and therefore 
are not included in table 1.
    Section 314.530(f) requires that an applicant first submit a 
petition for stay of action before requesting an order from a court for 
a stay of action pending review. The burden hours for Sec.  314.530(f) 
are approved under OMB control number 0910-0191, and therefore are not 
included in table 1.
    Section 314.550 requires an applicant with a new drug product being 
considered for accelerated approval to submit copies of all promotional 
materials to FDA during the preapproval and post-approval periods.
    Section 314.610(b)(1) requires that applicants include a plan or 
approach to postmarketing study commitments in applications for 
approval of new drugs when human efficacy studies are not ethical or 
feasible, and provide status reports of postmarketing study 
commitments. The burden estimate for Sec.  314.610(b)(1) is included in 
table 1 under the estimates for Sec. Sec.  314.50(a) through (f), (k), 
and (l); and 314.81(b)(2)).
    Section 314.610(b)(3) requires that applicants propose labeling to 
be provided to patient recipients in applications for approval of new 
drugs when human efficacy studies are not ethical or feasible. The 
burden estimate for Sec.  314.610(b)(3) is included in table 1 under 
the estimates for Sec.  314.50(e).
    Section 314.630 requires that applicants provide postmarketing 
safety reporting for applications for approval of new drugs when human 
efficacy studies are not ethical or feasible. The burden hours for 
Sec.  314.630 are approved under OMB control numbers 0910-0230 and 
0910-0291, and therefore not included in table 1.
    Section 314.640 requires that applicants provide promotional 
materials for applications for approval of new drugs when human 
efficacy studies are not ethical or feasible. The burden estimate for 
Sec.  [thinsp]314.640 is included in table 1 under the estimates for 
Sec.  314.81(b)(3)(i)).
    In the Federal Register of May 26, 2017 (82 FR 24351), we published 
a 60-day notice requesting public comment on the proposed extension of 
this collection of information. No comments were received in response 
to the four information collection topics solicited in the notice. 
However, one comment was received regarding NDA submission criteria, 
and we have directed the comment to the appropriate Agency component 
for consideration.
    Accordingly, we estimate the burden for this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                 Number of
  21 CFR section/[FDA form       Number of     responses per   Total annual     Average  burden     Total hours
            No.]                respondents     respondent       responses       per  response
----------------------------------------------------------------------------------------------------------------
314.50 (a)-(g), (i)-(l)--                378            1.33             503  1,921.............         966,263
 Content and format of a
 505(b)(1) or 505(b)(2)
 application.
314.52--Non-infringement of                7               3              21  16................             336
 patents (NDAs).
314.95--Non-infringement of              209               3             627  16................          10,032
 patents (ANDAs).
314.60--Amendments..........             564            9.96           5,618  80................         449,440
314.65--Withdrawal of                     27           71.63           1,934  2.................           3,868
 unapproved applications.
314.70 and 314.71--                      838            7.04           5,897  150...............         884,550
 Supplements and submissions.
314.72--Change of ownership.             142            2.04             289  2.................             578
314.81--Other postmarketing              342           19.98           6,834  8.................          54,672
 reports and 314.81(b)(1)
 [3331 and 3331a] field
 alert reports.
314.81(b)(2) [2252]--Annual              913            5.07           4,632  40................         185,280
 reports.
314.81(b)(3)(i) [2253]--                 529           81.66          43,198  2.................          86,396
 Promotional labeling.
314.94(a) and (d)--ANDA                180.5            3.75           676.5  480...............         324,720
 content.
314.96(a)(1)--Amendments to              514           26.66          13,647  80................       1,091,760
 unapproved ANDAs.
314.97--Supplements to ANDAs             343           17.57           6,027  80................         482,160
314.99(a)--Responsibilities              265            7.04           1,867  2.................           3,734
 of ANDA Applicants.
314.101(a)--ANDA filing.....               1               1               1  0.50..............            0.50
                                                                              (30 minutes)......
314.103--Dispute resolution.              75               2             150  5.................             750
314.420--Drug Master Files..             500            2.06           1,028  61................          62,708
314.550--Promotional                      29            7.76             225  120...............          27,000
 material and subpart H
 applications.
                             -----------------------------------------------------------------------------------

[[Page 58407]]

 
    Total...................  ..............  ..............  ..............  ..................     4,634,247.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ For most elements, ``Total Hours'' reflects estimated average burden as calculated by multiplying the number
  of respondents by the frequency of response and time necessary for the corresponding activity. In other
  instances, ``Total Hours'' is the average burden we attribute to all respondents, where individual respondent
  and time-frequency values have been estimated. All figures have been rounded to the nearest whole number.

    We retain the currently approved burden estimate for the 
information collection associated with the provisions identified above. 
At the same time, we have added burden estimate associated with Sec.  
314.103, although in an effort to reduce burden, we have issued 
associated guidance to assist respondents with the relevant information 
collection.

    Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26670 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58403 information is missing. The ambulance percent prepayment medical review of comments be faxed to the Office of provider/supplier or beneficiary can those claims. Information and Regulatory Affairs, rectify the error(s) and resubmit the Additional information is available on OMB, Attn: FDA Desk Officer, Fax: prior authorization request with the CMS website at http://go.cms.gov/ 202–395–7285, or emailed to oira_ appropriate documentation. PAAmbulance. submission@omb.eop.gov. All • Scenario 4: If an ambulance comments should be identified with the provider or supplier renders a service to III. Collection of Information OMB control number 0910–0001. Also a beneficiary and does not request prior Requirements include the FDA docket number found authorization by the fourth round trip in Section 1115A(d)(3) of the Act states in brackets in the heading of this a 30-day period, and the claim is that chapter 35 of title 44, United States document. submitted to the MAC for payment, then Code (the Paperwork Reduction Act of FOR FURTHER INFORMATION CONTACT: the claim will be stopped for 1995), shall not apply to the testing and prepayment review and documentation evaluation of models or expansion of Domini Bean, Office of Operations, will be requested. such models under this section. Food and Drug Administration, Three ++ If the claim is determined to be for Consequently, this document need not White Flint North, 10A–12M, 11601 services that were not medically be reviewed by the Office of Landsdown St., North Bethesda, MD necessary or for which there was Management and Budget under the 20852, 301–796–5733, PRAStaff@ insufficient documentation, the claim authority of the Paperwork Reduction fda.hhs.gov. will be denied, and all current policies Act of 1995. SUPPLEMENTARY INFORMATION: In and procedures regarding liability for compliance with 44 U.S.C. 3507, FDA payment will apply. The ambulance IV. Regulatory Impact Statement has submitted the following proposed provider/supplier or the beneficiary, or This document announces a 1-year collection of information to OMB for both, can appeal the claim denial if they extension of the Medicare Prior review and clearance. believe the denial was inappropriate. Authorization Model for Repetitive ++ If the claim is determined to be Scheduled Non-Emergent Ambulance Application for FDA Approval To payable, it will be paid. Transport. Therefore, there are no Market a New Drug Under the model, we will work to regulatory impact implications OMB Control Number 0910–0001— limit any adverse impact on associated with this notice. Extension beneficiaries and to educate Authority: Section 1115A of the Social Under section 505(a) of the Federal beneficiaries about the process. If a prior Security Act. Food, Drug, and Cosmetic Act (the authorization request is non-affirmed, and the claim is still submitted by the Dated: November 16, 2017. FD&C Act) (21 U.S.C. 355(a)), a new ambulance provider/supplier, the claim Seema Verma, drug may not be commercially marketed will be denied, but beneficiaries will Administrator, Centers for Medicare & in the United States, imported, or continue to have all applicable Medicaid Services. exported from the United States, unless administrative appeal rights. We will [FR Doc. 2017–26759 Filed 12–8–17; 4:15 pm] an approval of an application filed with also work to implement a process that BILLING CODE 4120–01–P FDA under section 505(b) or (j) of the will help identify alternate FD&C Act is effective with respect to transportation resources for such drug. The Agency has codified beneficiaries who receive non- DEPARTMENT OF HEALTH AND regulations regarding applications for affirmative decisions. HUMAN SERVICES FDA approval to market a new drug Only one prior authorization request under 21 CFR part 314. This collection per beneficiary per designated time Food and Drug Administration of information supports the regulatory period can be provisionally affirmed. If [Docket No. FDA–2013–N–0523] requirements found in those regulations. the initial ambulance provider/supplier The collection of information is cannot complete the total number of Agency Information Collection necessary for FDA to make a scientific prior authorized transports (for Activities: Submission for Office of and technical determination whether example, the initial ambulance Management and Budget Review; the product is safe and effective for use, company closes or no longer services Comment Request; Applications for and is summarized as follows: that area), the initial request is Food and Drug Administration Section 314.50(a) requires that an cancelled. In this situation, a Approval To Market a New Drug application form (Form FDA 356h) be subsequent prior authorization request submitted that includes information may be submitted for the same AGENCY: Food and Drug Administration, about the applicant, the submission, and beneficiary and must include the HHS. a checklist of enclosures. required documentation in the ACTION: Notice. Section 314.50(b) requires that an submission. If multiple ambulance index be submitted with the archival providers/suppliers are providing SUMMARY: The Food and Drug copy of the application and that it transports to the beneficiary during the Administration (FDA) is announcing reference certain sections of the same or overlapping time period, the that a proposed collection of application. prior authorization decision will only information has been submitted to the Section 314.50(c) requires that a cover the ambulance provider/supplier Office of Management and Budget summary of the application be indicated in the provisionally affirmed (OMB) for review and clearance under submitted that presents a good general ethrower on DSK3G9T082PROD with NOTICES prior authorization request. Any the Paperwork Reduction Act of 1995. synopsis of all the technical sections ambulance provider/supplier submitting DATES: Fax written comments on the and other information in the claims for repetitive, scheduled non- collection of information by January 11, application. emergent ambulance transports for 2018. Section 314.50(d) requires that the which no prior authorization request is ADDRESSES: To ensure that comments on new drug application (NDA) contain the submitted by the fourth round trip in a the information collection are received, following technical sections about the 30-day period will be subject to 100 OMB recommends that written new drug: Chemistry, manufacturing, VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

58404 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices and controls; nonclinical pharmacology applicant also is required to amend the Section 314.81(b)(3)(i) requires that and toxicology; human application to document receipt of the drug advertisements and promotional pharmacokinetics and bioavailability; required notice. Burden hours for these labeling be submitted to FDA (Form microbiology; clinical data; statistical; provisions are included in OMB control FDA 2253). and pediatric use sections. number 0910–0786. Section 314.81(b)(3)(iii) sets forth Section 314.50(e) requires the Section 314.53 sets forth the patent reporting requirements for sponsors applicant to submit samples of the drug information requirements for applicants who withdraw an approved drug if requested by FDA. In addition, the who submit applications or product from sale. The burden hours for archival copy of the application must amendments to the application filed § 314.81(b)(3)(iii) are approved under include copies of the label and all under section 505(b)(2) of the FD&C Act OMB control number 0910–0045 labeling for the drug. or supplements to the approved (Registration of Producers of Drugs and Section 314.50(f) requires that case 505(b)(2) application. Burden hours for Listing of Drugs in Commercial report forms and tabulations be these collections are approved in OMB Distribution), and therefore are not submitted with the archival copy. control number 0910–0786. included in table 1. Section 314.50(h) requires that patent Section 314.54 sets forth the content Section 314.90 sets forth requirements information, as described under requirements for applications filed for sponsors who request waivers from § 314.53, be submitted with the under section 505(b)(2) of the FD&C Act. FDA for compliance with §§ 314.50 application. However, burden hours for The burden estimate for 505(b)(2) through 314.81. The information § 314.50(h) are approved under OMB applications is included in table 1 under collection burden estimate for NDA control numbers 0910–0513 (Patent the estimates for § 314.50(a) through (g) waiver requests is included in table 1 Certification Forms FDA 3542 and FDA and (i) through (l). under the estimates for each section that 3542a) and 0910–0786 (Abbreviated Section 314.55 sets forth the is in part 314, subpart B. New Drug Applications (ANDAs) and assessment requirements for each Section 314.93 sets forth requirements 505(b)(2) Applications), and are application. The burden estimate for for submitting a suitability petition to therefore not included among the 505(b)(2) applications is included in request a change from a listed drug in estimates found in table 1. table 1 under the estimates for accordance with § 10.20 (21 CFR 10.20) Section 314.50(i) requires that patent § 314.50(a) through (g) and (i) through and § 10.30. The burden hours for certification information be submitted (l). § 314.93 are approved under OMB in section 505(b)(2) applications for Section 314.60 sets forth reporting control number 0910–0191 patents claiming the drug substance, requirements and patent certification (Administrative Practices and drug product, or method of use. requirements for sponsors who amend Procedures; Formal Evidentiary Public Sections 314.50(i)(1)(i)(C) and 314.54(i) an unapproved 505(b)(2) application. Hearing) and are not included in and (j) require that patent certification Burden hours for the § 314.60(f) table 1. information be submitted for each collections are approved under OMB Section 314.94(a) through (d) require patent listed in the ‘‘Approved Drug control number 0910–0786. that an ANDA contain the following Products with Therapeutic Equivalence Section 314.65 states that the sponsor information: Application form; table of Evaluations’’ (the Orange Book) for a must notify FDA when withdrawing an contents; basis for ANDA submission; drug product approved in an NDA that unapproved application. conditions of use; active ingredients; is pharmaceutically equivalent to the Sections 314.70 and 314.71 require route of administration, dosage form, proposed drug product in the original that supplements be submitted to FDA and strength; bioequivalence; labeling; 505(b)(2) application and was submitted for certain changes to an approved chemistry, manufacturing, and controls; and was approved before the original application. samples; and patent certification. 505(b)(2) application was submitted. Section 314.72 requires sponsors to Section 314.95 requires that any Burden for these provisions is included report to FDA any transfer of ownership notice of certification of invalidity or under OMB control number 0910–0786. of an application. non-infringement of a patent to each Section 314.50(j) requires that Section 314.80(c)(1) and (2) set forth patent owner and the NDA holder be applicants who request a period of requirements for expedited adverse drug sent by ANDA applicants. marketing exclusivity submit certain experience postmarketing reports and Section 314.96 sets forth requirements information with the application. followup reports, as well as for periodic for amendments to an unapproved Section 314.50(k) requires that the adverse drug experience postmarketing ANDA. application contain a financial reports (Form FDA 3500A). Section 314.97 sets forth requirements certification or disclosure statement or Section 314.80(i) establishes for submitting supplements to an both. recordkeeping requirements for reports approved ANDA for certain changes to Section 314.50(l) requires that an of postmarketing adverse drug the application. Approval of burden archival, review, and field copy of the experiences. The burden hours for hours for information collections for application be submitted, including the § 314.80(i) are approved under OMB §§ 314.95 through 314.97 are covered content of labeling and all labeling and control numbers 0910–0230 (Adverse under OMB control number 0910–0786. labels. Drug Experience Reporting) and 0910– Section 314.98(a) sets forth Section 314.52 requires that any 0291 (MedWatch: FDA’s Medical postmarketing adverse drug experience notice of certification of invalidity, Reporting Program), and therefore reporting and recordkeeping unenforceability, or non-infringement of burden estimates are not included in requirements for ANDAs. The burden a patent to each patent owner and the table 1. hours for § 314.98(a) are approved under ethrower on DSK3G9T082PROD with NOTICES NDA holder be sent by a section Section 314.81(b)(1) requires that OMB control numbers 0910–0230 and 505(b)(2) applicant that relies on a listed NDA and ANDA field alert reports be 0910–0291 and are not included in table drug. A 505(b)(2) applicant is required submitted to FDA (Forms FDA 3331 and 1 of this document. to amend the application at the time Form FDA 3331a). Section 314.98(b) requires other notice is provided to include a Section 314.81(b)(2) requires that postmarketing reports for ANDAs: Field statement certifying that the required annual reports be submitted to FDA alert reports (Form FDA 3331a), annual notice has been provided. A 505(b)(2) (Form FDA 2252). reports (Form FDA 2252), and VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58405 advertisements and promotional approved application holder who is an Section 314.126(c) sets forth labeling (Form FDA 2253). (The exclusive patent licensee waives its requirements for a petition to waive information collection burden estimate opportunity to file a legal action for criteria for adequate and well-controlled for field alert reports is included in table patent infringement within the 45-day studies. The burden hours for 1 of this document under § 314.81(b)(1); period, the patent owner or approved § 314.126(c) are approved under OMB the estimate for annual reports is application holder may submit to FDA control number 0910–0191 and included under § 314.81(b)(2); the a waiver in the specified format. The therefore are not included in table 1. estimate for advertisements and burden estimate for § 314.107(f) is Sections 314.150(a) and (b) and promotional labeling is included under included in table 1 under the estimates 314.151(a) and (b) set forth requirements § 314.81(b)(3)(i).) for § 314.50 (a) through (g) and (i) for the withdrawal of approval of an Section 314.99(a) requires that through (l) and is approved under OMB NDA or ANDA and the applicant’s sponsors comply with certain reporting control number 0910–0786. opportunity for a hearing and requirements for withdrawing an Section 314.110(b)(3) states that, after submission of comments. The burden unapproved ANDA and for a change in receipt of an FDA complete response hours for § 314.151(a) and (b) are ownership of an ANDA. letter, an applicant must either: (1) included under parts 10 through 16 Section 314.99(b) sets forth Resubmit the application addressing all hearing regulations, in accordance with requirements for sponsors who request the deficiencies identified in the § 314.201, and approved under OMB waivers from FDA for compliance with complete response letter; (2) withdraw control number 0910–0191 and §§ 314.92 through 314.99. (The the application; or (3) request an therefore are not included in table 1. information collection burden estimate opportunity for a hearing on the Section 314.151(c) sets forth the for ANDA waiver requests is included question of whether there are grounds requirements for withdrawal of approval in table 1 of this document under the for denying approval of the application. of an ANDA and the applicant’s estimates for each section that is in part The burden hours for § 314.110(b)(3) are opportunity to submit written objections 314, subpart C.) included under parts 10 through 16 (21 and participate in a limited oral hearing. Section 314.101(a) states that if FDA CFR parts 10 through 16, OMB control The burden hours for § 314.151(c) are refuses to file an application, the number 0910–0191) hearing regulations, included under parts 10 through 16 applicant may request an informal hearing regulations, in accordance with in accordance with § 314.201, and are conference with FDA and request that § 314.201, approved under OMB control not included in table 1. the application be filed over protest. number 0910–0191, and therefore are Section 314.102 covers Section 314.122(a) requires that an not included in table 1. communications between FDA and ANDA or a suitability petition that Section 314.153(b) sets forth the applicants, including requests for relies on a listed drug that has been requirements for suspension of an meetings. voluntarily withdrawn from sale must ANDA when the listed drug is Section 314.103 covers specified be accompanied by a petition seeking a voluntarily withdrawn for safety and dispute resolution. To assist determination whether the drug was effectiveness reasons, and the respondents with certain aspects of this withdrawn for safety or effectiveness applicant’s opportunity to present requirement, we have issued draft reasons. The burden hours for comments and participate in a limited guidance entitled ‘‘Requests for § 314.122(a) are approved under OMB oral hearing. The burden hours for Reconsideration at the Division Level control number 0910–0191 and § 314.152(b) are included under parts 10 Under GDUFA [the Generic Drug User therefore are not included in table 1. through 16 hearing regulations, in Fee Act]; Guidance for Industry.’’ Section 314.122(d) sets forth accordance with § 314.201, approved Section 314.107(c) requires notice to requirements for relisting petitions for under OMB control number 0910–0191, FDA by the first applicant to submit a unlisted discontinued products. The and therefore are not included in substantially complete ANDA burden hours for § 314.122(d) are table 1. containing a certification that a relevant approved under OMB control number Section 314.161(b) and (e) sets forth patent is invalid, unenforceable, or will 0910–0191 and therefore are not the requirements for submitting a not be infringed of the date of first included in table 1. petition to determine whether a listed commercial marketing. The burden Sections 314.125 and 314.127 state drug was voluntarily withdrawn from estimate for § 314.107(c) is included in that FDA may refuse to approve an NDA sale for safety or effectiveness reasons. table 1 under the estimates for or an ANDA and will provide the The burden hours for § 314.161(b) and § 314.50(a) through (g) and (i) through applicant written notice of an (e) are approved under OMB control (l). opportunity for a hearing under number 0910–0191 and therefore are not Section 314.107(e) requires that an § 314.200 along with the reason for included in table 1. applicant submit a copy of the entry of refusal to approve the application, Section 314.200(c), (d), and (e) the order or judgment to FDA within 10 including lack of a patent certification requires that applicants or others subject working days of a final judgment. The or statement with respect to each listed to a notice of opportunity for a hearing burden estimate for § 314.107(e) patent for an approved drug product who wish to participate in a hearing file applications is included in table 1 under that is pharmaceutically equivalent to a written notice of participation and the estimates for § 314.50(a) through (g) the drug product for which the original request for a hearing as well as the and (i) through (l) and is approved 505(b)(2) application is submitted and studies, data, and so forth, relied on. under OMB control number 0910–0786. was approved before the original Other interested persons may also Section 314.107(f) requires that 505(b)(2) was submitted. The burden submit comments on the notice. This ethrower on DSK3G9T082PROD with NOTICES ANDA or section 505(b)(2) applicants hours for §§ 314.125 and 314.127 (refuse section also sets forth the content and notify FDA immediately of the filing of to approve an ANDA) are included format requirements for the applicants’ any legal action filed within 45 days of under parts 10 through 16 hearing submission in response to notice of receipt of the notice of certification. A regulations (in accordance with opportunity for hearing. The burden patent owner must also notify FDA of § 314.201) and approved under OMB hours for § 314.200(c), (d), and (e) are the filing of any legal action for patent control number 0910–0191, and included under parts 10 through 16 infringement. If the patent owner or therefore are not included in table 1. hearing regulations, in accordance with VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

58406 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices § 314.201, are approved under OMB control number 0910–0191, and Section 314.610(b)(3) requires that control number 0910–0191, and therefore are not included in table 1. applicants propose labeling to be therefore are not included in table 1. Section 314.530(c) and (e) states that provided to patient recipients in Section 314.200(f) states that if FDA withdraws approval of a drug applications for approval of new drugs participants in a hearing may make a approved under the accelerated when human efficacy studies are not motion to the presiding officer for the approval procedures, the applicant has ethical or feasible. The burden estimate inclusion of certain issues in the the opportunity to request a hearing and for § 314.610(b)(3) is included in table 1 hearing. The burden hours for submit data and information. The under the estimates for § 314.50(e). § 314.200(f) are included under parts 10 burden hours for § 314.530(c) and (e) are Section 314.630 requires that through 16 hearing regulations, in included under parts 10 through 16 applicants provide postmarketing safety accordance with § 314.201, are hearing regulations, in accordance with reporting for applications for approval approved under OMB control number § 314.201, are approved under OMB of new drugs when human efficacy 0910–0191, and therefore are not control number 0910–0191, and studies are not ethical or feasible. The included in table 1. therefore are not included in table 1. burden hours for § 314.630 are approved Section 314.200(g) states that a person under OMB control numbers 0910–0230 Section 314.530(f) requires that an who responds to a proposed order from and 0910–0291, and therefore not applicant first submit a petition for stay FDA denying a request for a hearing included in table 1. of action before requesting an order provide sufficient data, information, and from a court for a stay of action pending Section 314.640 requires that analysis to demonstrate that there is a review. The burden hours for applicants provide promotional genuine and substantial issue of fact, § 314.530(f) are approved under OMB materials for applications for approval which justifies a hearing. The burden control number 0910–0191, and of new drugs when human efficacy hours for § 314.200(g) are included therefore are not included in table 1. studies are not ethical or feasible. The under parts 10 through 16 hearing Section 314.550 requires an applicant burden estimate for § 314.640 is regulations, in accordance with § 314.201, are approved under OMB with a new drug product being included in table 1 under the estimates control number 0910–0191, and considered for accelerated approval to for § 314.81(b)(3)(i)). therefore are not included in table 1. submit copies of all promotional In the Federal Register of May 26, Section 314.420 states that an materials to FDA during the preapproval 2017 (82 FR 24351), we published a 60- applicant may submit to FDA a drug and post-approval periods. day notice requesting public comment master file in support of an application, Section 314.610(b)(1) requires that on the proposed extension of this in accordance with certain content and applicants include a plan or approach to collection of information. No comments format requirements. postmarketing study commitments in were received in response to the four Section 314.430 states that data and applications for approval of new drugs information collection topics solicited information in an application are when human efficacy studies are not in the notice. However, one comment disclosable under certain conditions, ethical or feasible, and provide status was received regarding NDA submission unless the applicant shows that reports of postmarketing study criteria, and we have directed the extraordinary circumstances exist. The commitments. The burden estimate for comment to the appropriate Agency burden hours for § 314.430 are included § 314.610(b)(1) is included in table 1 component for consideration. under parts 10 through 16 hearing under the estimates for §§ 314.50(a) Accordingly, we estimate the burden regulations, in accordance with through (f), (k), and (l); and for this collection of information as § 314.201, are approved under OMB 314.81(b)(2)). follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 Number of Average Number of Total annual 21 CFR section/[FDA form No.] responses per burden per Total hours respondents responses respondent response 314.50 (a)–(g), (i)–(l)—Content and format of a 505(b)(1) 378 1.33 503 1,921 .............. 966,263 or 505(b)(2) application. 314.52—Non-infringement of patents (NDAs) .................... 7 3 21 16 ................... 336 314.95—Non-infringement of patents (ANDAs) .................. 209 3 627 16 ................... 10,032 314.60—Amendments ......................................................... 564 9.96 5,618 80 ................... 449,440 314.65—Withdrawal of unapproved applications ................ 27 71.63 1,934 2 ..................... 3,868 314.70 and 314.71—Supplements and submissions .......... 838 7.04 5,897 150 ................. 884,550 314.72—Change of ownership ............................................ 142 2.04 289 2 ..................... 578 314.81—Other postmarketing reports and 314.81(b)(1) 342 19.98 6,834 8 ..................... 54,672 [3331 and 3331a] field alert reports. 314.81(b)(2) [2252]—Annual reports ................................... 913 5.07 4,632 40 ................... 185,280 314.81(b)(3)(i) [2253]—Promotional labeling ...................... 529 81.66 43,198 2 ..................... 86,396 314.94(a) and (d)—ANDA content ...................................... 180.5 3.75 676.5 480 ................. 324,720 314.96(a)(1)—Amendments to unapproved ANDAs ........... 514 26.66 13,647 80 ................... 1,091,760 314.97—Supplements to ANDAs ........................................ 343 17.57 6,027 80 ................... 482,160 ethrower on DSK3G9T082PROD with NOTICES 314.99(a)—Responsibilities of ANDA Applicants ................ 265 7.04 1,867 2 ..................... 3,734 314.101(a)—ANDA filing ..................................................... 1 1 1 0.50 ................ 0.50 (30 minutes) ... 314.103—Dispute resolution ............................................... 75 2 150 5 ..................... 750 314.420—Drug Master Files ............................................... 500 2.06 1,028 61 ................... 62,708 314.550—Promotional material and subpart H applications 29 7.76 225 120 ................. 27,000 VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58407 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2—Continued Number of Average Number of Total annual 21 CFR section/[FDA form No.] responses per burden per Total hours respondents responses respondent response Total .............................................................................. ........................ ........................ ........................ ........................ 4,634,247.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 For most elements, ‘‘Total Hours’’ reflects estimated average burden as calculated by multiplying the number of respondents by the fre- quency of response and time necessary for the corresponding activity. In other instances, ‘‘Total Hours’’ is the average burden we attribute to all respondents, where individual respondent and time-frequency values have been estimated. All figures have been rounded to the nearest whole number. We retain the currently approved ADDRESSES: You may submit comments • For written/paper comments burden estimate for the information as follows. Please note that late, submitted to the Dockets Management collection associated with the untimely filed comments will not be Staff, FDA will post your comment, as provisions identified above. At the same considered. Electronic comments must well as any attachments, except for time, we have added burden estimate be submitted on or before February 12, information submitted, marked and associated with § 314.103, although in 2018. The https://www.regulations.gov identified, as confidential, if submitted an effort to reduce burden, we have electronic filing system will accept as detailed in ‘‘Instructions.’’ issued associated guidance to assist comments until midnight Eastern Time Instructions: All submissions received respondents with the relevant at the end of February 12, 2018. must include the Docket No. FDA– information collection. Comments received by mail/hand 2014–N–1030 for ‘‘Agency Information delivery/courier (for written/paper Collection Activities; Proposed Dated: December 6, 2017. submissions) will be considered timely Collection; Comment Request; Food Leslie Kux, if they are postmarked or the delivery Allergen Labeling and Reporting.’’ Associate Commissioner for Policy. Received comments, those filed in a service acceptance receipt is on or [FR Doc. 2017–26670 Filed 12–11–17; 8:45 am] timely manner (see ADDRESSES), will be before that date. BILLING CODE 4164–01–P placed in the docket and, except for Electronic Submissions those submitted as ‘‘Confidential Submit electronic comments in the Submissions,’’ publicly viewable at DEPARTMENT OF HEALTH AND following way: https://www.regulations.gov or at the HUMAN SERVICES • Federal eRulemaking Portal: Dockets Management Staff between 9 https://www.regulations.gov. Follow the a.m. and 4 p.m., Monday through Food and Drug Administration instructions for submitting comments. Friday. Comments submitted electronically, • Confidential Submissions—To [Docket No. FDA–2014–N–1030] including attachments, to https:// submit a comment with confidential www.regulations.gov will be posted to information that you do not wish to be Agency Information Collection the docket unchanged. Because your made publicly available, submit your Activities; Proposed Collection; comment will be made public, you are comments only as a written/paper Comment Request; Food Allergen solely responsible for ensuring that your submission. You should submit two Labeling and Reporting comment does not include any copies total. One copy will include the confidential information that you or a information you claim to be confidential AGENCY: Food and Drug Administration, third party may not wish to be posted, with a heading or cover note that states HHS. such as medical information, your or ‘‘THIS DOCUMENT CONTAINS ACTION: Notice. anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The confidential business information, such Agency will review this copy, including SUMMARY: The Food and Drug the claimed confidential information, in Administration (FDA, the Agency, or as a manufacturing process. Please note that if you include your name, contact its consideration of comments. The we) is announcing an opportunity for second copy, which will have the public comment on the proposed information, or other information that identifies you in the body of your claimed confidential information collection of certain information by the redacted/blacked out, will be available Agency. Under the Paperwork comments, that information will be posted on https://www.regulations.gov. for public viewing and posted on Reduction Act of 1995 (PRA), Federal • If you want to submit a comment https://www.regulations.gov. Submit Agencies are required to publish notice both copies to the Dockets Management with confidential information that you in the Federal Register concerning each Staff. If you do not wish your name and do not wish to be made available to the proposed collection of information, contact information to be made publicly public, submit the comment as a including each proposed extension of an available, you can provide this written/paper submission and in the existing collection of information, and information on the cover sheet and not manner detailed (see ‘‘Written/Paper to allow 60 days for public comment in in the body of your comments and you Submissions’’ and ‘‘Instructions’’). response to the notice. This notice must identify this information as solicits comments on the information Written/Paper Submissions ‘‘confidential.’’ Any information marked ethrower on DSK3G9T082PROD with NOTICES collection requirements for declaring Submit written/paper submissions as as ‘‘confidential’’ will not be disclosed major food allergens under the Federal follows: except in accordance with 21 CFR 10.20 Food, Drug, and Cosmetic Act (the • Mail/Hand delivery/Courier (for and other applicable disclosure law. For FD&C Act). written/paper submissions): Dockets more information about FDA’s posting DATES: Submit either electronic or Management Staff (HFA–305), Food and of comments to public dockets, see 80 written comments on the collection of Drug Administration, 5630 Fishers FR 56469, September 18, 2015, or access information by February 12, 2018. Lane, Rm. 1061, Rockville, MD 20852. the information at: https://www.gpo.gov/ VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1


Document Created: 2018-10-25 10:47:38
Document Modified: 2018-10-25 10:47:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by January 11, 2018.
ContactDomini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation82 FR 58403 
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