Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry; Availability; Extension of Comment Period, 72248-72249 [2021-27521]

Download as PDF 72248 Federal Register / Vol. 86, No. 242 / Tuesday, December 21, 2021 / Notices agencies, entities, and persons is reasonably necessary to assist in connection with HHS’s efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm. b. Information may be disclosed to another federal agency or federal entity when HHS determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the federal government, or national security, resulting from a suspected or confirmed breach. POLICIES AND PRACTICES FOR STORAGE OF RECORDS: The records are stored electronically. POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS: Records are retrieved by the parent’s, guardian’s, or third-party caretaker’s name or SSN. POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS: Upon approval of a disposition schedule by the National Archives and Records Administration (NARA), the records will be deleted when eligible for destruction under the schedule, if the records are no longer needed for administrative, audit, legal, or operational purposes. ACF anticipates requesting NARA’s approval of retention periods of approximately 60 days for the information contained in the transmission files (i.e., long enough to confirm receipt or to resend if necessary) and up to 7 years for the audit log records. Approved disposal methods for electronic records and media include overwriting, degaussing, erasing, disintegration, pulverization, burning, melting, incineration, shredding, or sanding. jspears on DSK121TN23PROD with NOTICES1 ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS: The system leverages cloud service providers that maintain an authority to operate in accordance with applicable laws, rules, and policies, including Federal Risk and Authorization Management Program (FedRAMP) requirements. Specific administrative, technical, and physical controls are in place to ensure that the records collected, maintained, and transmitted using the OCSE Data Center General Support System are secure from unauthorized access. Access to the VerDate Sep<11>2014 18:02 Dec 20, 2021 Jkt 256001 records within the system is restricted to authorized personnel who are advised of the confidentiality of the records and the civil and criminal penalties for misuse, and who sign a nondisclosure oath to that effect. Agency personnel are provided privacy and security training before being granted access to the records and annually thereafter. Additional safeguards include protecting the facilities where records are stored or accessed with security guards, badges, and cameras; limiting access to electronic databases to authorized users based on roles and either two-factor authentication or user ID and password (as appropriate); using a secured operating system protected by encryption, firewalls, and intrusion detection systems; reviewing security controls on a periodic basis; and using secure destruction methods prescribed in NIST SP 800–88 to dispose of eligible records. All safeguards conform to the HHS Information Security and Privacy Program, https://www.hhs.gov/ocio/ securityprivacy/. RECORD ACCESS PROCEDURES: To request access to a record about you in this system of records, submit a written access request to the System Manager identified in the ‘‘System Manager’’ section of this System of Records Notice (SORN). The request must reasonably describe the record sought and must include (for contact purposes and identity verification purposes) your full name, current address, telephone number and/or email address, date and place of birth, and signature, and (if needed by the agency) sufficient particulars contained in the records (such as your SSN) to enable the System Manager to distinguish between records on subject individuals with the same name. In addition, to verify your identity, your signature must be notarized or the request must include your written certification that you are the individual who you claim to be and that you understand that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense subject to a fine of up to $5,000. You may request that copies of the records be sent to you, or you may request an appointment to review the records in person (including with a person of your choosing, if you provide written authorization for agency personnel to discuss the records in that person’s presence). You may also request an accounting of disclosures that have been made of records about you, if any. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 CONTESTING RECORD PROCEDURES: To request correction of a record about you in this system of records, submit a written amendment request to the System Manager identified in the ‘‘System Manager’’ section of this SORN. The request must contain the same information required for an access request and include verification of your identity in the same manner required for an access request. In addition, the request must reasonably identify the record and specify the information contested, the corrective action sought, and the reasons for requesting the correction; and should include supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. NOTIFICATION PROCEDURES: To find out if the system of records contains a record about you, submit a written notification request to the System Manager identified in the ‘‘System Manager’’ section of this SORN. The request must identify this system of records, contain the same information required for an access request, and include verification of your identity in the same manner required for an access request. EXEMPTIONS PROMULGATED FOR THE SYSTEM: None. HISTORY: None. [FR Doc. 2021–27324 Filed 12–20–21; 8:45 am] BILLING CODE 4184–42–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0548] Data Standards for Drug and Biological Product Submissions Containing RealWorld Data; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled ‘‘Data Standards for Drug and Biological Product Submissions Containing RealWorld Data; Draft Guidance for Industry’’ that appeared in the Federal Register on October 22, 2021. The Agency is taking this action in response SUMMARY: E:\FR\FM\21DEN1.SGM 21DEN1 Federal Register / Vol. 86, No. 242 / Tuesday, December 21, 2021 / Notices to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the ‘‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry’’ published October 22, 2021 (86 FR 58672). Submit either electronic or written comments by February 4, 2022 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’’). jspears on DSK121TN23PROD with NOTICES1 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– 2021–D–0548 for ‘‘Data Standards for Drug and Biological Product VerDate Sep<11>2014 18:02 Dec 20, 2021 Jkt 256001 Submissions Containing Real-World Data; Draft Guidance for Industry.’’ 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 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.govinfo.gov/content/pkg/FR-201509-18/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 72249 your requests. See the SUPPLEMENTARY section for electronic access to the draft guidance document. INFORMATION FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993–0002, 301– 796–2500, dianne.paraoan@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: I. Background In the Federal Register of October 22, 2021, FDA published a notice of availability with a 60-day comment period to provide comments on the draft guidance entitled ‘‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Draft Guidance for Industry.’’ FDA has received requests to extend the comment period to allow sufficient time to develop and submit meaningful comments. FDA has considered the requests and is extending the comment period for 45 days, until February 4, 2022. The Agency believes that a 45-day extension allows adequate time for interested persons to submit comments. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: December 15, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–27521 Filed 12–20–21; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72248-72249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27521]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0548]


Data Standards for Drug and Biological Product Submissions 
Containing Real-World Data; Draft Guidance for Industry; Availability; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability entitled 
``Data Standards for Drug and Biological Product Submissions Containing 
Real-World Data; Draft Guidance for Industry'' that appeared in the 
Federal Register on October 22, 2021. The Agency is taking this action 
in response

[[Page 72249]]

to requests for an extension to allow interested persons additional 
time to submit comments.

DATES: FDA is extending the comment period on the ``Data Standards for 
Drug and Biological Product Submissions Containing Real-World Data; 
Draft Guidance for Industry'' published October 22, 2021 (86 FR 58672). 
Submit either electronic or written comments by February 4, 2022 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-2021-D-0548 for ``Data Standards for Drug and Biological Product 
Submissions Containing Real-World Data; Draft Guidance for Industry.'' 
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 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.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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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: Dianne Paraoan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-
796-2500, [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:

I. Background

    In the Federal Register of October 22, 2021, FDA published a notice 
of availability with a 60-day comment period to provide comments on the 
draft guidance entitled ``Data Standards for Drug and Biological 
Product Submissions Containing Real-World Data: Draft Guidance for 
Industry.'' FDA has received requests to extend the comment period to 
allow sufficient time to develop and submit meaningful comments. FDA 
has considered the requests and is extending the comment period for 45 
days, until February 4, 2022. The Agency believes that a 45-day 
extension allows adequate time for interested persons to submit 
comments.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27521 Filed 12-20-21; 8:45 am]
BILLING CODE 4164-01-P

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