Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3161 

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 

MRTPA (section 911(d) of FD&C Act) ................................ 3 1 3 10,000 30,000 

Environmental analysis (21 CFR 25.15) .............................. 3 1 3 320 960 

Request for a meeting prior to submitting a MRTPA .......... 8 1 8 40 320 

All activities related to postmarket surveillance studies, including submission of protocols, conduct of studies, and 

annual reporting (section 911(g)(2)(C)(ii), 911(i)(1) and 

(2)) .................................................................................... 5 1 5 5,000 25,000 

Requests for renewal (section 911(g)(2)(C)(i) and 

911(h)(4)) .......................................................................... 1 1 1 1,000 1,000 

Total Hours ................................................................... ........................ ........................ ........................ ........................ 57,280 

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

Table 1 describes the annual reporting 

burden as a result of submitting a 

MRTPA. FDA estimates that it will 

receive three MPRTAs annually and that 

it will take the applicant 10,000 hours 

per response to conduct studies and 

collect the information needed to 

support an MRTPA. FDA is also 

including an estimation of the burden 

associated with preparing 

environmental analyses. FDA estimates 

that it will take an additional 320 hours 

to prepare any environmental analyses. 

FDA encourages persons considering 

developing a MRTPA to meet with the 

Center for Tobacco Products to discuss 

MRTPA submission and investigational 

requirements. FDA anticipates that eight 

respondents considering developing 

MRTPAs may request meetings with 

FDA. FDA estimates it will take 40 

hours per response to prepare a meeting 

request, including background 

information. 

Section 911 of the FD&C Act requires 

applicants to whom FDA issues orders 

to conduct postmarket surveillance and 

studies and submit relevant information 

to FDA on an annual basis. Applicants 

must submit and receive FDA approval 

of surveillance protocols. FDA estimates 

that it will take 5,000 hours per 

response to collect and submit the 

protocol information to FDA, conduct 

the postmarket surveillance and studies 

and to submit results of postmarket 

surveillance and studies to FDA 

annually. FDA expects five respondents 

to carry out postmarket surveillance and 

studies annually. 

Because orders issued under section 

911(g) of the FD&C Act are valid for 

only a set number of years, FDA expects 

applicants will submit requests for 

renewal. Because the dates on which 

orders are issued and the length of the 

period for which the order is valid will 

vary, FDA expects one request for 

renewal annually. FDA estimates that it 

will take 1,000 hours to prepare the 

request for renewal. 

The estimated total burden hours for 

this collection of information is 

estimated to be 57,280. These burden 

estimates were computed using FDA 

staff expertise and by reviewing 

comments received from recent FDA 

information collections for other 

tobacco-related initiatives. In addition, 

FDA notes that due to the many 

similarities between the content 

requirements of sections 910(b)(1) (from 

PMTAs) and 911(d) (for MRTPAs) of the 

FD&C Act, and the likelihood that many 

respondents will submit joint PMTAs 

and MRTPAs, or cross-reference the 

applications, that part of the collection 

of information burden for respondents 

submitting an MRTPA will be captured 

in the preparation of the PMTA. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01121 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6879] 

Electronic Study Data Submission; 

Data Standards; Timetable for Updates 

to the Food and Drug Administration 

Data Standards Catalog for Study Data 

Submitted Electronically Under the 

Federal Food, Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the timetable for updates to 

the FDA Data Standards Catalog for 

study data submitted electronically in 

new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), biologics license applications 

(BLAs), and certain investigational new 

drug applications (INDs) to the Center 

for Biologics Evaluation and Research 

(CBER) and the Center for Drug 

Evaluation and Research (CDER). The 

initial implementation timetable for 

submitting standardized study data in 

electronic format was 24 months for 

NDAs, ANDAs, and applications, and 36 

months for certain INDs after 

publication of the final guidance 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized 

Study’’ in December 2014. When future 

updates to study data standards listed in 

the FDA Data Standards Catalog 

(Catalog) occur, these updated standards 

will be required in studies with a start 

date no earlier than 12 months after a 

Federal Register notice announcing 

such updates is published. When future 

new study data standards are listed in 

the Catalog, these new standards will be 

required in studies with a start date no 

earlier than 24 months after a Federal 

Register notice announcing such new 

standards is published. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

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, 


sradovich on DSK3GMQ082PROD with NOTICES
3162 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

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–N–6879 for ‘‘Electronic Study 

Data Submission; Data Standards; 

Timetable for Updates to the FDA Data 

Standards Catalog for Electronic 

Submissions of Study Data.’’ 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. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, 

cderdatastandards@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, Stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 17, 2014, FDA published final 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’ posted on FDA’s Study Data 

Standards Resources web page at 

https://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The guidance implemented 

the electronic submission requirements 

of section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 379k–1) for study data contained 

in NDAs, ANDAs, applications under 

subsection (a) or (k) of section 351 of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 262), and certain INDs. The 

initial implementation date for the 

electronic submission requirement for 

standardized study data was 24 months 

after final guidance for NDAs, ANDAs, 

and applications under subsection (a) or 

(k) of section 351 of the PHS Act 

(December 17, 2016) and 36 months 

after final guidance for INDs (December 

17, 2017). To provide a consistent 

timetable for announcing FDA’s support 

and requirement for future version 

updates and new study data standards, 

the guidance states that a Federal 

Register notice will specify a transition 

date with a specific month and day for 

the transition date. When a Federal 

Register notice is published after March 

15 of the current calendar year, the 

transition date will be March 15 of the 

next calendar year. 

When future version updates to 

supported study data standards and new 

study data standards are announced in 

the Federal Register, they will be 

required in studies that have a start date 

no earlier than 12 months after the 

transition date for version updates and 

no earlier than 24 months after the 

transition date for new study data 

standards. Table 1 presents an example 

of timetables for the requirement to use 

future version updates and new study 

data standards after publication of 

Federal Register notices. In the 

example, a new study data transport 

format standard and a version update to 

the Study Data Tabulation Model 

Implementation Guide (SDTMIG) each 

have a single date listed when the 

standard will be required. The new 

study data transport format is supported 

as of the date of the Federal Register 

notice, but will only be required in 

studies that start 24 months after the 

transition date of March 15, 2019. The 

SDTMIG version update is supported as 

of the date of the Federal Register 

notice, but will only be required in 

studies that start 12 months after the 

transition date of March 15, 2019. 

TABLE 1—EXAMPLE OF TIMETABLES FOR REQUIRED STUDY DATA STANDARDS

FDA data standards catalog 

Federal 

Register 

notice of FDA 

support 

(yyyy–mm–dd) 

Transition date 

(yyyy–mm–dd) 

Date 

requirement 

begins 

(yyyy–mm–dd) 

New Study Data Transport .............................................................................................. 2019–02–20 2019–03–15 2021–03–15 

SDTMIG Version Update ................................................................................................. 2018–09–05 2019–03–15 2020–03–15 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3163 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01119 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2343] 

Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a draft 

guidance for industry #245 entitled 

‘‘Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals.’’ This draft guidance 

document, when finalized, will help 

animal food facilities comply with the 

requirements for hazard analysis and 

risk-based preventive controls under our 

regulation ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 23, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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. 

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– 

2016–D–2343 for ‘‘Hazard Analysis and 

Risk-Based Preventive Controls for Food 

for Animals.’’ 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 guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed 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: 

Jenny Murphy, Center for Veterinary 

Medicine (HFV–200), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–6246, 

jenny.murphy@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353) enables 

FDA to better protect public (human 

and animal) health by helping to ensure 

the safety and security of the food 

supply. FSMA enables FDA to focus 

more on preventing animal food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

Section 103 of FSMA amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), by adding section 418 (21 

U.S.C. 350g) with requirements for 

hazard analysis and risk-based 

preventive controls for establishments 

that are required to register as food 

facilities under our regulations in 21 

CFR part 1, subpart H, in accordance 

with section 415 of the FD&C Act (21 

U.S.C. 350d). We have established 

regulations to implement the hazard 

analysis and risk-based preventive 

controls requirements within part 507 

(21 CFR part 507). 

We are announcing the availability of 

a draft guidance for industry #245 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Food for 

Animals.’’ This multi-chapter draft 

guidance for industry is intended to 


sradovich on DSK3GMQ082PROD with NOTICES