Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51421 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–1064] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Petitions for 

Exemption From Preemption 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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. 

DATES: Fax written comments on the 

collection of information by December 

6, 2017. 

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 0910–0277. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

State Petitions for Exemption From 

Preemption 

OMB Control Number 0910–0277— 

Extension 

Under section 403A(b) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 343–1(b)), States 

may petition FDA for exemption from 

Federal preemption of State food 

labeling and standard-of-identity 

requirements. Section 100.1(d) (21 CFR 

100.1(d)) sets forth the information a 

State is required to submit in such a 

petition. The information required 

under § 100.1(d) enables FDA to 

determine whether the State food 

labeling or standard-of-identity 

requirement satisfies the criteria of 

section 403A(b) of the FD&C Act for 

granting exemption from Federal 

preemption. 

In the Federal Register of June 15, 

2017 (82 FR 27491), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received no comments. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 100.1(d) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Form of petition .................................................................... 1 1 1 40 40 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The reporting burden for § 100.1(d) is 

minimal because petitions for 

exemption from preemption are seldom 

submitted by States. In the last 3 years, 

we have received one new petition for 

exemption from preemption; therefore, 

we estimate that one or fewer petitions 

will be submitted annually. 

Dated: November 1, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24106 Filed 11–3–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–3101] 

Abbreviated New Drug Applications: 

Pre-Submission of Facility Information 

Related to Prioritized Generic Drug 

Applications (Pre-Submission Facility 

Correspondence); Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

draft guidance for industry entitled 

‘‘ANDAs: Pre-Submission of Facility 

Information Related to Prioritized 

Generic Drug Applications (PreSubmission Facility Correspondence).’’ 

FDA is revising the draft guidance 

because, after issuance of the original 

draft guidance, the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) was 

amended by the FDA Reauthorization 

Act of 2017, which resulted in changes 

to the pre-submission of facility 

information. Pre-submitting facility 

information enables the Agency to 

determine whether inspection of a 

facility is necessary and, if so, to begin 

inspection planning in advance of an 

abbreviated new drug application 

(ANDA) receipt. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 5, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit either electronic or written 

comments concerning the collection of 

information proposed in the draft 

guidance by January 5, 2018. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 


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51422 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2017–D–3101 for ‘‘ANDAs: PreSubmission of Facility Information 

Related to Prioritized Generic Drug 

Applications (Pre-Submission Facility 

Correspondence).’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Nikhil Thakur, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 4161, 

Silver Spring, MD 20993, 301–796– 

5536. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘ANDAs: Pre-Submission of 

Facility Information Related to 

Prioritized Generic Drug Applications 

(Pre-Submission Facility 

Correspondence).’’ The first draft of this 

document, entitled ‘‘ANDAs: PreSubmission Facility Correspondence 

Associated with Priority Submissions,’’ 

was issued pursuant to 21 CFR 10.115 

in June 2017. The docket number has 

not changed since the first draft of this 

document was issued, and it is not 

necessary to resubmit comments already 

submitted to the docket. The Agency 

will consider comments submitted with 

respect to the first draft of this 

document in finalizing the revised 

document. 

The Agency is issuing this revised 

draft guidance to describe the process 

through which prospective generic drug 

applicants submit facility information in 

advance of an original ANDA, prior 

approval supplement (PAS), PAS 

amendment, or ANDA amendment 

(hereafter collectively referred to as 

ANDA). FDA is revising the draft 

guidance because, after issuance of the 

original draft guidance, section 

505(j)(11) of the FD&C Act (21 U.S.C. 

355(j)(11)) as added by section 801 of 

the FDA Reauthorization Act of 2017 

(FDARA) resulted in changes to the presubmission of facility information. 

In 2016 and 2017, FDA, regulated 

industry, and public stakeholders 

conducted negotiations concerning 

reauthorization of the Generic Drug User 

Fee Amendments (GDUFA II). A chief 

product of these congressionally 

mandated discussions was the ‘‘GDUFA 

Reauthorization Performance Goals and 

Program Enhancements, FYs 2018– 

2022’’ (GDUFA II Commitment Letter) 

available at: https://www.fda.gov/ 

downloads/ForIndustry/UserFees/ 

GenericDrugUserFees/UCM282505.pdf. 

Together, the Generic Drug User Fee 

Amendments of 2017 and the GDUFA II 

Commitment Letter describe FDA’s 

performance goals, as well as changes 

and improvements to the user fee 

program. 

On August 18, 2017, FDARA, which 

reauthorized the Generic Drug User Fee 

Amendments (Title III) as well as other 

provisions related to generic drugs (Title 

VIII), was signed into law. In particular, 

section 801 of the FDARA added section 

505(j)(11) to the FD&C Act to address 

priority review of generic drugs. One of 

the enhancements specified in both 

Title VIII, section 801 of FDARA, and 

the GDUFA II Commitment Letter is a 

mechanism to enable a shorter review 

goal (priority review goal) for certain 

priority original ANDAs, PASs, PAS 

amendments, and ANDA amendments 

through the pre-submission of facility 

information, including sections of the 

ANDA determined to be relevant by 

FDA. Specifically, this guidance 

describes: 

• The content and format of the 

facility information that should be 

submitted to enable FDA’s assessment 

of facilities listed in the pre-submission. 


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Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51423 

• Timeframes for pre-submitting 

sections of the ANDA containing 

complete, accurate information, and the 

intersection of these timeframes with 

submission of the ANDA. 

• The possible outcomes of the 

Agency’s assessment of pre-submitted 

ANDA sections containing facility 

information. 

• When and how the Agency notifies 

an applicant about the status of the presubmitted ANDA sections containing 

facility information. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ANDAs: Pre-Submission of Facility 

Information Related to Prioritized 

Generic Drug Applications (PreSubmission Facility Correspondence). It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This guidance is not subject 

to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing the 

proposed collection of information set 

forth in this notice of availability that 

would result from the pre-submission of 

facility information. 

With respect to the following 

collection of information, FDA invites 

comment on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Draft Guidance for Industry on 

ANDAs: Pre-Submission of Facility 

Information Related to Prioritized 

Generic Drug Applications (PreSubmission Facility Correspondence). 

Description: As described in the draft 

guidance, section 505(j)(11) of the FD&C 

Act was added by section 801 of 

FDARA. Pre-submitting facility 

information enables the Agency to 

determine whether inspection of a 

facility is necessary and, if so, to begin 

inspection planning in advance of 

ANDA receipt. 

This draft guidance document refers 

to previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by OMB under the 

PRA. Existing regulations at 21 CFR 

314.94 provide the content and format 

of an ANDA, and consistent with 

GDUFA II, this draft guidance describes 

the relevant sections of an ANDA that 

should be submitted as part of the presubmission of facility information. The 

information collections associated with 

the submission of these ANDA sections 

are approved under OMB control 

number 0910–0001. 

There are information collections 

proposed in the draft guidance that are 

not already addressed under the 

approved control numbers covering 

ANDA submissions. Section IV of the 

draft guidance describes the information 

that should be included in the presubmission of facility information to 

enable FDA’s facility assessment: 

A. The planned ANDA pre-assigned 

number to be submitted with the presubmission, which the applicant must 

request from FDA before submitting the 

pre-submission; 

B. Cover letter accompanying the presubmission, which includes a statement 

of justification for the expedited review 

request, a statement of inspection 

readiness, a statement identifying the 

Reference Listed Drug, and the 

anticipated date of the applicant’s 

ANDA submission; and 

C. Certification statement to be 

submitted with the applicant’s ANDA 

stating either that the applicant has 

made no changes to the pre-submitted 

facility information, or that the only 

change was made to exclude a facility 

as described in 505(j)(11)(B) of the 

FD&C Act. (Changes other than those 

permitted under 505(j)(11)(B) of the 

FD&C Act should be identified in the 

ANDA cover letter. The applicant will 

also need to confirm the accuracy of the 

information provided in the Form FDA 

356h submitted with the ANDA, and 

update accordingly.) 

Section VI of the draft guidance 

describes the format used to submit the 

pre-submission of facility information, 

which is the electronic Common 

Technical Document (eCTD) format. 

Further, as explained in section V of the 

draft guidance, the pre-submission must 

be submitted not later than 60 days 

prior to the planned ANDA submission. 

We estimate that a total of 

approximately 220 applicants (‘‘number 

of respondents’’ in table 1) will submit 

annually approximately 275 presubmissions as described above and in 

the draft guidance (‘‘total annual 

responses’’ in table 1). We estimate that 

preparing and submitting the portion of 

each pre-submission that is not already 

addressed under approved control 

numbers covering ANDA submissions 

will take approximately 1.1 hours 

(‘‘average burden per response’’ in table 

1). This includes time spent preparing 

and submitting a cover letter 

accompanying the pre-submission of 

facility information. We estimate that 

approximately 10 percent of applicants 

will submit statements notifying the 

Agency that the applicant has decided 

not to submit an ANDA, and we have 

incorporated the estimated time to 

prepare and submit such a statement in 

table 1. 

We estimate that approximately 198 

applicants will submit annually 

approximately 248 certifications (‘‘total 

annual responses’’ in table 1) verifying 

either that the applicant has made no 

changes to the pre-submitted facility 

information, or that the only change was 

made to exclude a facility as described 

in 505(j)(11)(B) of the FD&C Act. We 

estimate that preparing and submitting 

each certification will take 

approximately 4 hours (‘‘average burden 

per response’’ in table 1). 

We base our estimates for the number 

of applicants and the number of presubmissions on information from our 

database of annual ANDA submissions, 

on the criteria set forth in the Agency’s 

Manual of Policies and Procedures 

5240.3, Prioritization of the Review of 

Original ANDAs, Amendments, and 

Supplements (available at: https://

www.fda.gov/downloads/AboutFDA/ 

CentersOffices/OfficeofMedical

ProductsandTobacco/CDER/Manualof

PoliciesProcedures/UCM407849.pdf), 

and the number of ‘‘priority’’ 

submissions. Our estimate of the time 

applicants would need to prepare and 

submit the portions of each presubmission not already addressed under 

approved control numbers covering 


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51424 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 

ANDA submissions, as well as the presubmission certification statement 

(referenced in table 1), takes into 

consideration that much of this content 

is related to information already 

gathered for the ANDA submission. We 

invite comments on these estimates. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Pre-Submission of Facility Information ................................ 220 1.25 275 1.1 303 

Certification statement submitted with the ANDA ............... 198 1.25 248 4 990 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or https://www.

regulations.gov. 

Dated: October 31, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24099 Filed 11–3–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–N–0258; FDA– 

2010–N–0623; FDA–2007–N–0383; FDA– 

2009–N–0360; FDA–2016–N–4620; FDA– 

2013–N–1496; FDA–2007–N–0220; FDA– 

2017–N–1848; FDA–2017–N–1066; FDA– 

2015–D–3327; FDA–2011–D–0689] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB 

control No. 

Date 

approval 

expires 

Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission to Information to a 

Master File in Support of Petitions; and Electronic Submission Using FDA 3053 ............................................. 0910–0016 9/30/2020 

Voluntary Cosmetic Registration Program .............................................................................................................. 0910–0027 9/30/2020 

Radioactive Drug Research Committees ................................................................................................................ 0910–0053 9/30/2020 

FDA Safety Communication Readership Survey .................................................................................................... 0910–0341 9/30/2020 

Medical Devices; Reports for Corrections and Removals ...................................................................................... 0910–0359 9/30/2020 

Generic FDA Rapid Response Surveys .................................................................................................................. 0910–0500 9/30/2020 

Guidance for Industry: Pharmacogenomic Data Submissions ................................................................................ 0910–0557 9/30/2020 

Cosmetic Labeling Regulations ............................................................................................................................... 0910–0599 9/30/2020 

Annual Reporting for Custom Device Exemption .................................................................................................... 0910–0767 9/30/2020 

GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation ....................................................... 0910–0843 9/30/2020 

DeNovo Classification Process (Evaluation of Automatic Class II Designation) .................................................... 0910–0844 9/30/2020 

Dated: November 1, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24121 Filed 11–3–17; 8:45 am] 

BILLING CODE 4164–01–P 


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