[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Pages 44304-44305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1450]


Electronic Submissions; Data Standards; Support for the 
International Institute of Electrical and Electronics Engineers 
Bioinformatics Computations and Analyses Standard for Bioinformatic 
Workflows

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
support for use in regulatory submissions the current version of the 
International Institute of Electrical and Electronics Engineers (IEEE) 
bioinformatics computations and analyses standard for bioinformatic 
workflows (BioCompute) and an update to include this standard in the 
FDA Data Standards Catalog for the submission of high-throughput 
sequencing (HTS) data in new drug applications (NDAs), abbreviated new 
drug applications (ANDAs), biologics license applications (BLAs), and 
investigational new drug applications (INDs) to the Center for 
Biologics Evaluation and Research (CBER), Center for Drug Evaluation 
and Research (CDER), and Center for Food Safety and Applied Nutrition 
(CFSAN).

DATES: Submit either electronic or written comments on the notice by 
August 21, 2020.

ADDRESSES: You may submit either electronic or written comments 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-

[[Page 44305]]

2020-N-1450 for ``Electronic Submissions; Data Standards; Support for 
the International Institute of Electrical and Electronics Engineers 
Bioinformatics Computations and Analyses Standard for Bioinformatic 
Workflows.'' 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, 240-402-7500.
     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 laws. 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: 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; or Chenoa Conley, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
1117, Silver Spring, MD 20993-0002, 301-796-0035; or Cindee Hogan, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2181.

SUPPLEMENTARY INFORMATION: FDA is announcing support for the use in 
regulatory submissions the current version of the IEEE BioCompute 
standard (available at https://standards.ieee.org/standard/) and an 
update to include this standard in the FDA Data Standards Catalog for 
the submission of HTS data in NDAs, ANDAs, BLAs, and INDs to CBER, 
CDER, and CFSAN.
    Scientific workflows have emerged as a model for representing and 
managing complex scientific computations. The BioCompute standard 
facilitates the exchange of HTS bioinformatics workflows (i.e., 
computations and analyses) between various organizations by specifying 
the information needed to understand and organize bioinformatic 
analyses. Currently, the range of bioinformatics tools and associated 
parameters of those tools makes it difficult to describe, exchange, and 
assess the reproducibility of a complex analysis in a standardized 
format.
    The BioCompute standard represents a distillation of the 
bioinformatics workflows, describing the mechanisms for each step on 
the pipeline. The pipeline steps are organized into groups of 
conceptually related information or domains, which provides the ability 
to describe the full extent of the analysis, the purpose of the 
experiment, and any other relevant information. BioCompute tracks the 
flow of data from the beginning to the end of the bioinformatics 
pipeline, making transformations apparent at each step. In this way, an 
analysis formatted according to the BioCompute standard provides the 
manifest (metadata) for the HTS data files.

    Dated: July 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15771 Filed 7-21-20; 8:45 am]
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