82 FR 56035 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Signatures
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 226 (November 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 226 (November 27, 2017)
| Page Range | 56035-56036 | |
| FR Document | 2017-25453 |
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)] [Notices] [Pages 56035-56036] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25453] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0076] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Signatures AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 27, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0303. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7729, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Electronic Records; Electronic Signatures OMB Control Number 0910-0303--Extension This information collection supports FDA regulations; specifically, in part 11 (21 CFR part 11), which sets forth criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. Under these regulations, records and reports may be submitted to FDA electronically provided the Agency has stated its ability to accept the records electronically in an Agency-established public docket and that the other requirements of part 11 are met. The recordkeeping provisions in part 11 (Sec. Sec. 11.10, 11.30, 11.50, and 11.300) require the following standard operating procedures to assure appropriate use of, and precautions for, systems using electronic records and signatures: (1) Sec. 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records; (2) Sec. 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records; (3) Sec. 11.50 specifies procedures and controls for persons who use electronic signatures; and (4) Sec. 11.300 specifies controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. The reporting provision (Sec. 11.100) requires persons to certify in writing to FDA that they will regard electronic signatures used in their systems as the legally binding equivalent of traditional handwritten signatures. The burden created by the information collection provision of this regulation is a one-time burden associated with the creation of standard operating procedures, validation, and certification. The Agency anticipates the use of electronic media will substantially reduce the paperwork burden associated with maintaining FDA required records. The respondents are businesses and other for-profit organizations, State or local governments, Federal Agencies, and nonprofit institutions. In the Federal Register of June 19, 2017 (82 FR 27838), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the information collection topics solicited in the notice. However, one comment was received regarding a related Agency draft guidance entitled, ``Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR part 11--Questions and Answers,'' and the comment has been directed to the appropriate Agency components for consideration. We therefore estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of responses per Total annual per response Total hours respondents respondent responses (in hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- 11.100............................................................. 4,500 1 4,500 1 4,500 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 56036]] Table 2--Estimated Annual Recordkeeping Burden 1 ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total annual burden per 21 CFR section respondents responses per responses response (in Total hours respondent hours) ---------------------------------------------------------------------------------------------------------------- 11.10........................... 2,500 1 2,500 20 50,000 11.30........................... 2,500 1 2,500 20 50,000 11.50........................... 4,500 1 4,500 20 90,000 11.300.......................... 4,500 1 4,500 20 90,000 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 280,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25453 Filed 11-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices 56035
guidance specifies the circumstances DATES: Fax written comments on the electronic records and signatures: (1)
under which packages and homogenous collection of information by December § 11.10 specifies procedures and
cases of product that are not labeled 27, 2017. controls for persons who use closed
with a product identifier and that are in ADDRESSES: To ensure that comments on systems to create, modify, maintain, or
the pharmaceutical distribution supply the information collection are received, transmit electronic records; (2) § 11.30
chain at the time of the effective date of OMB recommends that written specifies procedures and controls for
the requirements of section 582 of the comments be faxed to the Office of persons who use open systems to create,
FD&C Act shall be exempted from Information and Regulatory Affairs, modify, maintain, or transmit electronic
certain requirements of section 582, it OMB, Attn: FDA Desk Officer, Fax: 202– records; (3) § 11.50 specifies procedures
will have binding effect upon 395–7285, or emailed to oira_ and controls for persons who use
finalization. submission@omb.eop.gov. All electronic signatures; and (4) § 11.300
comments should be identified with the specifies controls to ensure the security
II. Electronic Access
OMB control number 0910–0303. Also and integrity of electronic signatures
Persons with access to the internet include the FDA docket number found based upon use of identification codes
may obtain the guidance document at in brackets in the heading of this in combination with passwords. The
https://www.fda.gov/Drugs/Guidance document. reporting provision (§ 11.100) requires
ComplianceRegulatoryInformation/ persons to certify in writing to FDA that
FOR FURTHER INFORMATION CONTACT:
Guidances/default.htm, https://www. they will regard electronic signatures
Domini Bean, Office of Operations,
fda.gov/BiologicsBloodVaccines/ used in their systems as the legally
Food and Drug Administration, Three
GuidanceComplianceRegulatory binding equivalent of traditional
White Flint North, 10A–12M, 11601
Information/Guidances/default.htm, or handwritten signatures.
Landsdown St., North Bethesda, MD
https://www.regulations.gov. The burden created by the
20852, 301–796–7729, PRAStaff@
Dated: November 20, 2017. fda.hhs.gov. information collection provision of this
Leslie Kux, regulation is a one-time burden
SUPPLEMENTARY INFORMATION: In associated with the creation of standard
Associate Commissioner for Policy. compliance with 44 U.S.C. 3507, FDA operating procedures, validation, and
[FR Doc. 2017–25457 Filed 11–24–17; 8:45 am] has submitted the following proposed certification. The Agency anticipates the
BILLING CODE 4164–01–P collection of information to OMB for use of electronic media will
review and clearance. substantially reduce the paperwork
Electronic Records; Electronic burden associated with maintaining
DEPARTMENT OF HEALTH AND
Signatures FDA required records. The respondents
HUMAN SERVICES
are businesses and other for-profit
OMB Control Number 0910–0303— organizations, State or local
Food and Drug Administration
Extension governments, Federal Agencies, and
This information collection supports nonprofit institutions.
[Docket No. FDA–2011–N–0076]
FDA regulations; specifically, in part 11 In the Federal Register of June 19,
Agency Information Collection (21 CFR part 11), which sets forth 2017 (82 FR 27838), we published a 60-
Activities; Submission for Office of criteria for acceptance of electronic day notice requesting public comment
Management and Budget Review; records, electronic signatures, and on the proposed extension of this
Comment Request; Electronic handwritten signatures executed to collection of information. No comments
Signatures electronic records as equivalent to paper were received in response to the
records. Under these regulations, information collection topics solicited
AGENCY: Food and Drug Administration, records and reports may be submitted to in the notice. However, one comment
HHS. FDA electronically provided the Agency was received regarding a related Agency
ACTION: Notice. has stated its ability to accept the draft guidance entitled, ‘‘Use of
records electronically in an Agency- Electronic Records and Electronic
SUMMARY: The Food and Drug established public docket and that the Signatures in Clinical Investigations
Administration (FDA) is announcing other requirements of part 11 are met. Under 21 CFR part 11—Questions and
that a proposed collection of The recordkeeping provisions in part Answers,’’ and the comment has been
information has been submitted to the 11 (§§ 11.10, 11.30, 11.50, and 11.300) directed to the appropriate Agency
Office of Management and Budget require the following standard operating components for consideration.
(OMB) for review and clearance under procedures to assure appropriate use of, We therefore estimate the burden of
the Paperwork Reduction Act of 1995. and precautions for, systems using this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in hours)
asabaliauskas on DSKBBXCHB2PROD with NOTICES
11.100 .................................................................................. 4,500 1 4,500 1 4,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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![56036 Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in hours)
11.10 .................................................................................... 2,500 1 2,500 20 50,000
11.30 .................................................................................... 2,500 1 2,500 20 50,000
11.50 .................................................................................... 4,500 1 4,500 20 90,000
11.300 .................................................................................. 4,500 1 4,500 20 90,000
Total .............................................................................. ........................ ........................ ........................ ........................ 280,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 20, 2017. ADDRESSES: The public workshop will that must be submitted to FDA and all
Leslie Kux, be held at the Conference Center at 1777 participating investigators under the
Associate Commissioner for Policy. F Street NW., Washington, DC 20006. IND safety reporting regulations at
[FR Doc. 2017–25453 Filed 11–24–17; 8:45 am] For additional travel and hotel § 312.32. The focus of this draft
BILLING CODE 4164–01–P
information, please refer to the guidance is on safety information that is
following Web site: https:// only interpretable in the aggregate and
healthpolicy.duke.edu/events/fda-ind- therefore, this guidance is most
DEPARTMENT OF HEALTH AND safety-reporting-meeting. There will also applicable to late-stage studies and drug
HUMAN SERVICES be a live webcast for those unable to development programs that have
attend the meeting in person (see multiple studies. This guidance
Food and Drug Administration Streaming Webcast of Public contains recommendations on the
Workshop). following matters that are most relevant
[Docket No. FDA–2015–D–4562] to sponsors’ review of aggregate data for
FOR FURTHER INFORMATION CONTACT:
Lauren Wedlake, Center for Drug IND safety reporting: (1) The entity that
Safety Assessment for Investigational reviews aggregate data, (2) methods for
New Drug Safety Reporting; Public Evaluation and Research, Food and
Drug Administration, 10903 New aggregate analyses of safety data, (3)
Workshop maintaining trial integrity while
Hampshire Ave., Bldg. 51, Rm. 6362,
AGENCY: Food and Drug Administration, Silver Spring, MD 20993, 301–796– reviewing unblinded data, and (4)
HHS. 2728, Lauren.Wedlake@fda.hhs.gov. reporting criteria. This guidance also
contains recommendations regarding
ACTION: Notice of public workshop. SUPPLEMENTARY INFORMATION:
the development of a plan for safety
SUMMARY: The Food and Drug I. Background surveillance, and includes
Administration (FDA, the Agency, or The IND safety reporting requirements considerations and recommendations.
we) is announcing the public workshop Timely reporting of meaningful safety
for human drugs and biological
entitled ‘‘Safety Assessment for IND information allows FDA to consider
products being studied under an IND
Safety Reporting.’’ Convened by the whether any changes in study conduct
are stated in § 312.32 (21 CFR 312.32).
Duke-Robert J. Margolis, MD, Center for should be made beyond those initiated
In 2012, FDA published final guidance
Health Policy at Duke University and by the sponsor and allows investigators
for industry and investigators regarding
supported by a cooperative agreement to make any needed changes to protect
implementation of these requirements
with FDA, the purpose of the public subjects. Simply reporting all serious
entitled ‘‘Safety Reporting Requirements
workshop is to bring the stakeholder adverse events, however, including
for INDs and BA/BE Studies.1 ’’ During
community together to discuss a variety those where there is little reason to
the evaluation of comments to the draft consider them suspected adverse
of topics related to ‘‘Safety Assessment guidance for industry and investigators
for Investigational New Drug (IND) reactions (suspected adverse reactions
entitled ‘‘Safety Reporting Requirements being those with a reasonable possibility
Safety Reporting.’’ This public for INDs and BA/BE Studies’’ (Docket
workshop is organized in response to of having been caused by the drug), does
No. FDA–2010–D–0482) and at meetings not serve this purpose because it may
public comments received to Docket No. with stakeholders, FDA identified the obscure safety information that is
FDA–2015–D–4562 for the draft need for additional guidance on IND relevant to the investigational drug.
guidance ‘‘Safety Assessment for IND safety reporting. The draft guidance for Sponsors’ effective processes for a
Safety Reporting’’ issued in December industry entitled ‘‘Safety Assessment for systematic approach to safety
2015 requesting a public meeting to IND Safety Reporting’’ was issued in surveillance, coupled with IND safety
discuss the draft guidance and its December 2015 2 as a follow-on to the reporting of suspected adverse reactions
implications. The public workshop is guidance for industry and investigators to FDA and all participating
intended to engage external entitled ‘‘Safety Reporting Requirements investigators (and subsequent reporting
stakeholders in discussions related to for INDs and BA/BE Studies’’ and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
to involved institutional review boards),
finalizing the draft guidance entitled provides recommendations for how allows all parties to focus on important
‘‘Safety Assessment for IND Safety sponsors of INDs can identify and safety issues and to take actions to
Reporting.’’ evaluate important safety information minimize the risks of participation in a
DATES: The public workshop will be clinical trial. Sponsors are encouraged
1 Available at: https://www.fda.gov/downloads/
held on January 11, 2018, from 9 a.m. to have internal processes for governing
Drugs/Guidances/UCM227351.pdf.
to 4 p.m., Eastern Time. See the 2 https://www.fda.gov/downloads/Drugs/ the safety surveillance and safety
SUPPLEMENTARY INFORMATION section for GuidanceComplianceRegulatoryInformation/ reporting for their development
registration date and information. Guidances/UCM477584.pdf. programs. Such process may include
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Document Created: 2017-11-25 01:08:39
Document Modified: 2017-11-25 01:08:39
| 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. | |
| Dates | Fax written comments on the collection of information by December 27, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7729, [email protected] | |
| FR Citation | 82 FR 56035 |
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