83 FR 3161 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 15 (January 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 15 (January 23, 2018)
| Page Range | 3161-3163 | |
| FR Document | 2018-01119 |
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)] [Notices] [Pages 3161-3163] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01119] ----------------------------------------------------------------------- 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, [[Page 3162]] 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.thefederalregister.org/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, [email protected]; 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, [email protected]. 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 ---------------------------------------------------------------------------------------------------------------- Federal Register notice of FDA Transition date Date requirement FDA data standards catalog support (yyyy-mm- (yyyy-mm-dd) begins (yyyy-mm- dd) 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 ---------------------------------------------------------------------------------------------------------------- [[Page 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
![Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3161
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent
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, in-
cluding 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
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 describes the annual reporting will take 1,000 hours to prepare the study data submitted electronically in
burden as a result of submitting a request for renewal. new drug applications (NDAs),
MRTPA. FDA estimates that it will The estimated total burden hours for abbreviated new drug applications
receive three MPRTAs annually and that this collection of information is (ANDAs), biologics license applications
it will take the applicant 10,000 hours estimated to be 57,280. These burden (BLAs), and certain investigational new
per response to conduct studies and estimates were computed using FDA drug applications (INDs) to the Center
collect the information needed to staff expertise and by reviewing for Biologics Evaluation and Research
support an MRTPA. FDA is also comments received from recent FDA (CBER) and the Center for Drug
including an estimation of the burden information collections for other Evaluation and Research (CDER). The
associated with preparing tobacco-related initiatives. In addition, initial implementation timetable for
environmental analyses. FDA estimates FDA notes that due to the many submitting standardized study data in
that it will take an additional 320 hours similarities between the content electronic format was 24 months for
to prepare any environmental analyses. requirements of sections 910(b)(1) (from NDAs, ANDAs, and applications, and 36
FDA encourages persons considering PMTAs) and 911(d) (for MRTPAs) of the months for certain INDs after
developing a MRTPA to meet with the FD&C Act, and the likelihood that many publication of the final guidance
Center for Tobacco Products to discuss respondents will submit joint PMTAs ‘‘Providing Regulatory Submissions in
MRTPA submission and investigational and MRTPAs, or cross-reference the Electronic Format—Standardized
requirements. FDA anticipates that eight applications, that part of the collection Study’’ in December 2014. When future
respondents considering developing of information burden for respondents updates to study data standards listed in
MRTPAs may request meetings with submitting an MRTPA will be captured the FDA Data Standards Catalog
FDA. FDA estimates it will take 40 in the preparation of the PMTA. (Catalog) occur, these updated standards
hours per response to prepare a meeting Dated: January 17, 2018. will be required in studies with a start
request, including background Leslie Kux, date no earlier than 12 months after a
information. Federal Register notice announcing
Associate Commissioner for Policy.
Section 911 of the FD&C Act requires such updates is published. When future
[FR Doc. 2018–01121 Filed 1–22–18; 8:45 am]
applicants to whom FDA issues orders new study data standards are listed in
BILLING CODE 4164–01–P
to conduct postmarket surveillance and the Catalog, these new standards will be
studies and submit relevant information required in studies with a start date no
to FDA on an annual basis. Applicants earlier than 24 months after a Federal
DEPARTMENT OF HEALTH AND
must submit and receive FDA approval Register notice announcing such new
HUMAN SERVICES
of surveillance protocols. FDA estimates standards is published.
that it will take 5,000 hours per Food and Drug Administration ADDRESSES: You may submit comments
response to collect and submit the as follows:
protocol information to FDA, conduct [Docket No. FDA–2017–N–6879]
the postmarket surveillance and studies Electronic Submissions
and to submit results of postmarket Electronic Study Data Submission;
Submit electronic comments in the
surveillance and studies to FDA Data Standards; Timetable for Updates
following way:
annually. FDA expects five respondents to the Food and Drug Administration • Federal eRulemaking Portal:
to carry out postmarket surveillance and Data Standards Catalog for Study Data https://www.regulations.gov. Follow the
studies annually. Submitted Electronically Under the instructions for submitting comments.
Because orders issued under section Federal Food, Drug, and Cosmetic Act Comments submitted electronically,
911(g) of the FD&C Act are valid for including attachments, to https://
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Food and Drug Administration,
only a set number of years, FDA expects HHS. www.regulations.gov will be posted to
applicants will submit requests for ACTION: Notice. the docket unchanged. Because your
renewal. Because the dates on which comment will be made public, you are
orders are issued and the length of the SUMMARY: The Food and Drug solely responsible for ensuring that your
period for which the order is valid will Administration (FDA or Agency) is comment does not include any
vary, FDA expects one request for announcing the timetable for updates to confidential information that you or a
renewal annually. FDA estimates that it the FDA Data Standards Catalog for third party may not wish to be posted,
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![Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3163
Dated: January 17, 2018. comments, that information will be FR 56469, September 18, 2015, or access
Leslie Kux, posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Associate Commissioner for Policy. • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2018–01119 Filed 1–22–18; 8:45 am] with confidential information that you 23389.pdf.
BILLING CODE 4164–01–P
do not wish to be made available to the Docket: For access to the docket to
public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper received, go to https://
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
Food and Drug Administration heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
[Docket No. FDA–2016–D–2343] follows: and/or go to the Dockets Management
• Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
Hazard Analysis and Risk-Based written/paper submissions): Dockets
Preventive Controls for Food for Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any
Animals; Draft Guidance for Industry; Drug Administration, 5630 Fishers
Availability guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
• For written/paper comments
AGENCY: Food and Drug Administration, Submit written requests for single
submitted to the Dockets Management
HHS. copies of the guidance to the Policy and
Staff, FDA will post your comment, as
ACTION: Notice of availability. Regulations Staff (HFV–6), Center for
well as any attachments, except for
Veterinary Medicine, Food and Drug
information submitted, marked and
SUMMARY: The Food and Drug Administration, 7500 Standish Pl.,
identified, as confidential, if submitted
Administration (FDA, we, or Agency) is Rockville, MD 20855. Send one self-
as detailed in ‘‘Instructions.’’
announcing the availability of a draft Instructions: All submissions received addressed adhesive label to assist that
guidance for industry #245 entitled must include the Docket No. FDA– office in processing your requests. See
‘‘Hazard Analysis and Risk-Based 2016–D–2343 for ‘‘Hazard Analysis and the SUPPLEMENTARY INFORMATION section
Preventive Controls for Food for Risk-Based Preventive Controls for Food for electronic access to the draft
Animals.’’ This draft guidance for Animals.’’ Received comments will guidance document.
document, when finalized, will help be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
animal food facilities comply with the those submitted as ‘‘Confidential Jenny Murphy, Center for Veterinary
requirements for hazard analysis and Submissions,’’ publicly viewable at Medicine (HFV–200), Food and Drug
risk-based preventive controls under our https://www.regulations.gov or at the Administration, 7519 Standish Pl.,
regulation ‘‘Current Good Dockets Management Staff between 9 Rockville, MD 20855, 240–402–6246,
Manufacturing Practice, Hazard a.m. and 4 p.m., Monday through jenny.murphy@fda.hhs.gov.
Analysis, and Risk-Based Preventive Friday. SUPPLEMENTARY INFORMATION:
Controls for Food for Animals.’’ • Confidential Submissions—To
DATES: Submit either electronic or submit a comment with confidential I. Background
written comments on the draft guidance information that you do not wish to be The FDA Food Safety Modernization
by July 23, 2018 to ensure that the made publicly available, submit your Act (FSMA) (Pub. L. 111–353) enables
Agency considers your comment on this comments only as a written/paper FDA to better protect public (human
draft guidance before it begins work on submission. You should submit two and animal) health by helping to ensure
the final version of the guidance. copies total. One copy will include the the safety and security of the food
ADDRESSES: You may submit comments information you claim to be confidential supply. FSMA enables FDA to focus
on any guidance at any time as follows: with a heading or cover note that states more on preventing animal food safety
‘‘THIS DOCUMENT CONTAINS problems rather than relying primarily
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The on reacting to problems after they occur.
Submit electronic comments in the Agency will review this copy, including Section 103 of FSMA amended the
following way: the claimed confidential information, in Federal Food, Drug, and Cosmetic Act
• Federal eRulemaking Portal: its consideration of comments. The (FD&C Act), by adding section 418 (21
https://www.regulations.gov. Follow the second copy, which will have the U.S.C. 350g) with requirements for
instructions for submitting comments. claimed confidential information hazard analysis and risk-based
Comments submitted electronically, redacted/blacked out, will be available preventive controls for establishments
including attachments, to https:// for public viewing and posted on that are required to register as food
www.regulations.gov will be posted to https://www.regulations.gov. Submit facilities under our regulations in 21
the docket unchanged. Because your both copies to the Dockets Management CFR part 1, subpart H, in accordance
comment will be made public, you are Staff. If you do not wish your name and with section 415 of the FD&C Act (21
solely responsible for ensuring that your contact information to be made publicly U.S.C. 350d). We have established
comment does not include any available, you can provide this regulations to implement the hazard
confidential information that you or a information on the cover sheet and not analysis and risk-based preventive
third party may not wish to be posted, in the body of your comments and you controls requirements within part 507
sradovich on DSK3GMQ082PROD with NOTICES
such as medical information, your or must identify this information as (21 CFR part 507).
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked We are announcing the availability of
confidential business information, such as ‘‘confidential’’ will not be disclosed a draft guidance for industry #245
as a manufacturing process. Please note except in accordance with 21 CFR 10.20 entitled ‘‘Hazard Analysis and Risk-
that if you include your name, contact and other applicable disclosure law. For Based Preventive Controls for Food for
information, or other information that more information about FDA’s posting Animals.’’ This multi-chapter draft
identifies you in the body of your of comments to public dockets, see 80 guidance for industry is intended to
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Document Created: 2018-01-23 01:09:07
Document Modified: 2018-01-23 01:09:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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, [email protected]; 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, [email protected] | |
| FR Citation | 83 FR 3161 |
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