81_FR_65099 81 FR 64916 - Reporting of Computational Modeling Studies in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability

81 FR 64916 - Reporting of Computational Modeling Studies in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 183 (September 21, 2016)

Page Range64916-64917
FR Document2016-22708

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Reporting of Computational Modeling Studies in Medical Device Submissions.'' The purpose of this guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation (CM&S) studies that are used as valid scientific evidence to support medical device submissions, and to assist FDA staff in the review of computational modeling and simulation studies by improving the consistency and predictability of the review of CM&S and facilitating full interpretation and complete review of those studies.

Federal Register, Volume 81 Issue 183 (Wednesday, September 21, 2016) 
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64916-64917]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1530]


Reporting of Computational Modeling Studies in Medical Device 
Submissions; Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Reporting of Computational 
Modeling Studies in Medical Device Submissions.'' The purpose of this 
guidance document is to provide recommendations to industry on the 
formatting, organization, and content of reports of computational 
modeling and simulation (CM&S) studies that are used as valid 
scientific evidence to support medical device submissions, and to 
assist FDA staff in the review of computational modeling and simulation 
studies by improving the consistency and predictability of the review 
of CM&S and facilitating full interpretation and complete review of 
those studies.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2013-D-1530] for ``Reporting of Computational Modeling Studies in 
Medical Device Submissions.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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

[[Page 64917]]

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 http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Reporting of Computational Modeling Studies in Medical Device 
Submissions'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Tina Morrison, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 2204, Silver Spring, MD 20993-0002, 301-796-6310.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Reporting of Computational Modeling Studies in 
Medical Device Submissions.'' This guidance is intended to provide 
recommendations to industry on the formatting, organization, and 
content of reports for CM&S studies that are used as valid scientific 
evidence to support medical device submissions.
    In the Federal Register on January 17, 2014 (79 FR 3211), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by April 17, 2014.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Reporting of Computational Modeling 
Studies in Medical Device Submissions''. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Reporting of Computational 
Modeling Studies in Medical Device Submissions'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1807 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 814, 
subparts A through E have been approved under OMB control number 0910-
0231; and the collections of information in 21 CFR part 814, subpart H 
have been approved under OMB control number 0910-0332.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22708 Filed 9-20-16; 8:45 am]
 BILLING CODE 4164-01-P

64916 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices products listed in the table, there was considered for reintroduction to the • Federal eRulemaking Portal: http:// significant unmet medical need. With market. www.regulations.gov. Follow the the approval of additional therapies Accordingly, the Agency will remove instructions for submitting comments. with less severe adverse drug effects, CHLOROMYCETIN (chloramphenicol) Comments submitted electronically, FDA has determined that the risks Capsules, 50 mg and 100 mg; including attachments, to http:// associated with CHLOROMYCETIN AMPHICOL (chloramphenicol) www.regulations.gov will be posted to (chloramphenicol) Capsules, 50 mg and Capsules, 100 mg; and the docket unchanged. Because your 100 mg; AMPHICOL (chloramphenicol) CHLOROMYCETIN PALMITATE comment will be made public, you are Capsules, 100 mg; and (chloramphenicol palmitate) Oral solely responsible for ensuring that your CHLOROMYCETIN PALMITATE Suspension, 150 mg/5 mL, from the list comment does not include any (chloramphenicol palmitate) Oral of drug products published in the confidential information that you or a Suspension, 150 mg/5 mL, as currently Orange Book. FDA will not accept or third party may not wish to be posted, labeled, outweigh the benefits. Most approve ANDAs that refer to these drug such as medical information, your or important, CHLOROMYCETIN products. anyone else’s Social Security number, or (chloramphenicol) Capsules, 50 mg and Dated: September 14, 2016. confidential business information, such 100 mg; AMPHICOL (chloramphenicol) as a manufacturing process. Please note Leslie Kux, Capsules, 100 mg; and that if you include your name, contact Associate Commissioner for Policy. information, or other information that CHLOROMYCETIN PALMITATE [FR Doc. 2016–22660 Filed 9–20–16; 8:45 am] identifies you in the body of your (chloramphenicol palmitate) Oral Suspension, 150 mg/5 mL, may cause a BILLING CODE 4164–01–P comments, that information will be number of adverse reactions, the most posted on http://www.regulations.gov. serious being bone marrow depression • If you want to submit a comment DEPARTMENT OF HEALTH AND with confidential information that you (anemia, thrombocytopenia, and HUMAN SERVICES do not wish to be made available to the granulocytopenia temporally associated with treatment). A boxed warning in the public, submit the comment as a Food and Drug Administration written/paper submission and in the prescribing information for chloramphenicol sodium succinate [Docket No. FDA–2013–D–1530] manner detailed (see ‘‘Written/Paper injection and chloramphenicol capsules Submissions’’ and ‘‘Instructions’’). Reporting of Computational Modeling and oral suspension states that serious Written/Paper Submissions Studies in Medical Device hypoplastic anemia, thrombocytopenia, Submissions; Guidance for Industry Submit written/paper submissions as and granulocytopenia are known to and Food and Drug Administration follows: occur after administration of • Mail/Hand delivery/Courier (for Staff; Availability chloramphenicol. The drug product written/paper submissions): Division of labeling recommends extensive safety AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food monitoring, including baseline blood HHS. and Drug Administration, 5630 Fishers studies followed by periodic blood ACTION: Notice. Lane, Rm. 1061, Rockville, MD 20852. studies approximately every 2 days • For written/paper comments during therapy. The boxed warning also SUMMARY: The Food and Drug submitted to the Division of Dockets describes fatal aplastic anemia Administration (FDA or Agency) is Management, FDA will post your associated with administration of the announcing the availability of the comment, as well as any attachments, drug and aplastic anemia attributed to guidance entitled ‘‘Reporting of except for information submitted, chloramphenicol that later terminated Computational Modeling Studies in marked and identified, as confidential, in leukemia. Published literature Medical Device Submissions.’’ The if submitted as detailed in suggests that the risk of fatal aplastic purpose of this guidance document is to ‘‘Instructions.’’ anemia associated with oral provide recommendations to industry Instructions: All submissions received formulations of chloramphenicol may on the formatting, organization, and must include the Docket No. [FDA– be higher than the risk associated with content of reports of computational 2013–D–1530] for ‘‘Reporting of the intravenous formulation. modeling and simulation (CM&S) Computational Modeling Studies in FDA has also reviewed approved studies that are used as valid scientific Medical Device Submissions.’’ Received labeling for the products and has evidence to support medical device comments will be placed in the docket determined that a Risk Evaluation and submissions, and to assist FDA staff in and, except for those submitted as Mitigation Strategy (REMS) would be the review of computational modeling ‘‘Confidential Submissions,’’ publicly required to ensure that the benefits of and simulation studies by improving the viewable at http://www.regulations.gov the drug outweigh its risks. The REMS consistency and predictability of the or at the Division of Dockets may include Elements to Assure Safe review of CM&S and facilitating full Management between 9 a.m. and 4 p.m., Use, including restricted distribution, interpretation and complete review of Monday through Friday. and a Medication Guide could be those studies. • Confidential Submissions—To required as part of the labeling. FDA has DATES: Submit either electronic or submit a comment with confidential determined that additional nonclinical written comments on this guidance at information that you do not wish to be and possibly clinical studies of safety any time. General comments on Agency made publicly available, submit your and efficacy would be necessary before guidance documents are welcome at any comments only as a written/paper mstockstill on DSK3G9T082PROD with NOTICES CHLOROMYCETIN (chloramphenicol) time. submission. You should submit two Capsules, 50 mg and 100 mg; ADDRESSES: You may submit comments copies total. One copy will include the AMPHICOL (chloramphenicol) as follows: information you claim to be confidential Capsules, 100 mg; and with a heading or cover note that states CHLOROMYCETIN PALMITATE Electronic Submissions ‘‘THIS DOCUMENT CONTAINS (chloramphenicol palmitate) Oral Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The Suspension, 150 mg/5 mL, could be following way: Agency will review this copy, including VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64917 the claimed confidential information, in Submissions.’’ This guidance is H have been approved under OMB its consideration of comments. The intended to provide recommendations control number 0910–0332. second copy, which will have the to industry on the formatting, Dated: September 15, 2016. claimed confidential information organization, and content of reports for Leslie Kux, redacted/blacked out, will be available CM&S studies that are used as valid Associate Commissioner for Policy. for public viewing and posted on http:// scientific evidence to support medical device submissions. [FR Doc. 2016–22708 Filed 9–20–16; 8:45 am] www.regulations.gov. Submit both copies to the Division of Dockets In the Federal Register on January 17, BILLING CODE 4164–01–P Management. If you do not wish your 2014 (79 FR 3211), FDA announced the name and contact information to be availability of the draft guidance document. Interested persons were DEPARTMENT OF HEALTH AND made publicly available, you can invited to comment by April 17, 2014. HUMAN SERVICES provide this information on the cover sheet and not in the body of your II. Significance of Guidance Food and Drug Administration comments and you must identify this information as ‘‘confidential.’’ Any This guidance is being issued [Docket No. FDA–2004–N–0451] information marked as ‘‘confidential’’ consistent with FDA’s good guidance will not be disclosed except in practices regulation (21 CFR 10.115). Food and Drug Administration accordance with 21 CFR 10.20 and other The guidance represents the current Modernization Act of 1997: applicable disclosure law. For more thinking of FDA on ‘‘Reporting of Modifications to the List of Recognized information about FDA’s posting of Computational Modeling Studies in Standards, Recognition List Number: comments to public dockets, see 80 FR Medical Device Submissions’’. It does 045 56469, September 18, 2015, or access not establish any rights for any person AGENCY: Food and Drug Administration, the information at: http://www.fda.gov/ and is not binding on FDA or the public. HHS. regulatoryinformation/dockets/ You can use an alternative approach if it satisfies the requirements of the ACTION: Notice. default.htm. Docket: For access to the docket to applicable statutes and regulations. SUMMARY: The Food and Drug read background documents or the III. Electronic Access Administration (FDA or Agency) is electronic and written/paper comments announcing a publication containing Persons interested in obtaining a copy received, go to http:// modifications the Agency is making to of the guidance may do so by www.regulations.gov and insert the the list of standards FDA recognizes for downloading an electronic copy from docket number, found in brackets in the use in premarket reviews (FDA the Internet. A search capability for all heading of this document, into the Recognized Consensus Standards). This Center for Devices and Radiological ‘‘Search’’ box and follow the prompts publication, entitled ‘‘Modifications to Health guidance documents is available and/or go to the Division of Dockets the List of Recognized Standards, at http://www.fda.gov/MedicalDevices/ Management, 5630 Fishers Lane, Rm. Recognition List Number: 045’’ DeviceRegulationandGuidance/ 1061, Rockville, MD 20852. (Recognition List Number: 045), will GuidanceDocuments/default.htm. An electronic copy of the guidance assist manufacturers who elect to Guidance documents are also available document is available for download declare conformity with consensus at http://www.regulations.gov. Persons from the Internet. See the standards to meet certain requirements unable to download an electronic copy SUPPLEMENTARY INFORMATION section for for medical devices. of ‘‘Reporting of Computational information on electronic access to the DATES: Submit electronic or written Modeling Studies in Medical Device guidance. Submit written requests for a comments concerning this document at Submissions’’ may send an email single hard copy of the guidance any time. These modifications to the list request to CDRH-Guidance@fda.hhs.gov document entitled ‘‘Reporting of of recognized standards are effective to receive an electronic copy of the Computational Modeling Studies in September 21, 2016. document. Please use the document Medical Device Submissions’’ to the number 1807 to identify the guidance ADDRESSES: You may submit comments Office of the Center Director, Guidance you are requesting. as follows: and Policy Development, Center for Devices and Radiological Health, Food IV. Paperwork Reduction Act of 1995 Electronic Submissions and Drug Administration, 10903 New This guidance refers to previously Submit electronic comments in the Hampshire Ave., Bldg. 66, Rm. 5431, approved collections of information following way: Silver Spring, MD 20993–0002. Send found in FDA regulations. These • Federal eRulemaking Portal: http:// one self-addressed adhesive label to collections of information are subject to www.regulations.gov. Follow the assist that office in processing your review by the Office of Management and instructions for submitting comments. request. Budget (OMB) under the Paperwork Comments submitted electronically, FOR FURTHER INFORMATION CONTACT: Tina Reduction Act of 1995 (44 U.S.C. 3501– including attachments, to http:// Morrison, Center for Devices and 3520). The collections of information in www.regulations.gov will be posted to Radiological Health, Food and Drug 21 CFR part 807, subpart E have been the docket unchanged. Because your Administration, 10903 New Hampshire approved under OMB control number comment will be made public, you are Ave., Bldg. 62, Rm. 2204, Silver Spring, 0910–0120; the collections of solely responsible for ensuring that your MD 20993–0002, 301–796–6310. information in 21 CFR part 812 have comment does not include any mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: been approved under OMB control confidential information that you or a number 0910–0078; the collections of third party may not wish to be posted, I. Background information in 21 CFR part 814, such as medical information, your or FDA is announcing the availability of subparts A through E have been anyone else’s Social Security number, or a guidance for industry and FDA staff approved under OMB control number confidential business information, such entitled ‘‘Reporting of Computational 0910–0231; and the collections of as a manufacturing process. Please note Modeling Studies in Medical Device information in 21 CFR part 814, subpart that if you include your name, contact VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2016-09-21 01:30:58
Document Modified: 2016-09-21 01:30:58
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.
DatesSubmit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
ContactTina Morrison, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2204, Silver Spring, MD 20993-0002, 301-796-6310.
FR Citation81 FR 64916 
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