82 FR 27838 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 116 (June 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 116 (June 19, 2017)
| Page Range | 27838-27840 | |
| FR Document | 2017-12619 |
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)] [Notices] [Pages 27838-27840] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12619] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0076] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements governing the acceptance of electronic records and electronic signatures. DATES: Submit either electronic or written comments on the collection of information by August 18, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 18, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-2011-N-0076 for ``Electronic Records; Electronic Signatures.'' Received [[Page 27839]] comments, those filed in a timely manner (see ADDRESSES), 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: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Electronic Records; Electronic Signatures--21 CFR Part 11; OMB Control Number 0910-0303--Extension FDA regulations in part 11 (21 CFR part 11) provide 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 electronically to FDA provided the Agency has stated its ability to electronically accept the records 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. FDA estimates the burden for the 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 27840]] Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Average burden Number of Number of Total annual per 21 CFR section recordkeepers records per records recordkeeping Total hours recordkeeper (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: June 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12619 Filed 6-16-17; 8:45 am] BILLING CODE 4164-01-P
![27838 Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Total annual Hours per
21 CFR section frequency Total hours
respondents responses response
per response
Content and format when seeking written recommenda-
tions; results of studies; amendments (316.10, 316.12 &
316.14) ............................................................................. 1 1 1 50 50
Content and format of a request for orphan-drug designa-
tion; request for verification of orphan-drug status;
amendments (316.20, 316.21 & 316.26) FDA Form
3671 .................................................................................. 496 1.25 620 150 93,000
60 1.5 90 5 450
Notifications of changes in agents (316.22) ........................ 70 1 70 2 140
Deficiency letters and granting orphan-drug designation
(316.24(a)) ........................................................................ 20 1 20 2 40
Submissions to change ownership of orphan-drug des-
ignation (316.27) .............................................................. 63 1 63 5 315
Annual reports (316.30) ....................................................... 744 1 744 3 2,232
Assurance of the availability of sufficient quantities of the
orphan drug; holder’s consent for the approval of other
marketing applications for the same drug (316.36) ......... 2 3 6 15 90
Total .............................................................................. ........................ ........................ ........................ ........................ 96,317
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has experienced increases in: (1) proposed collection of certain posted to the docket unchanged.
The number of submissions to change information by the Agency. Under the Because your comment will be made
ownership of orphan-drug designation Paperwork Reduction Act of 1995 public, you are solely responsible for
(21 CFR 316.27), (2) the number of (PRA), Federal Agencies are required to ensuring that your comment does not
annual reports 21 CFR 316.30, and (3) publish notice in the Federal Register include any confidential information
assurances of the availability of concerning each proposed collection of that you or a third party may not wish
sufficient quantities of the orphan drug information, including each proposed to be posted, such as medical
and the holder’s consent for the extension of an existing collection of information, your or anyone else’s
approval of other marketing information, and to allow 60 days for Social Security number, or confidential
applications for the same drug (21 CFR public comment in response to the business information, such as a
316.36). In contrast, however, the use of notice. This notice solicits comments on manufacturing process. Please note that
Form FDA 3671, the application form to requirements governing the acceptance if you include your name, contact
submit for product designation to the of electronic records and electronic information, or other information that
European Medicines Agency and to the signatures. identifies you in the body of your
FDA Office of Orphan Products, has comments, that information will be
DATES: Submit either electronic or
decreased from 6,760 to 450 total posted on https://www.regulations.gov/.
written comments on the collection of
burden hours. • If you want to submit a comment
information by August 18, 2017.
Dated: June 13, 2017. with confidential information that you
ADDRESSES: You may submit comments do not wish to be made available to the
Anna K. Abram, as follows. Please note that late,
Deputy Commissioner for Policy, Planning,
public, submit the comment as a
untimely filed comments will not be written/paper submission and in the
Legislation, and Analysis. considered. Electronic comments must
[FR Doc. 2017–12620 Filed 6–16–17; 8:45 am]
manner detailed (see ‘‘Written/Paper
be submitted on or before August 18, Submissions’’ and ‘‘Instructions’’).
BILLING CODE 4164–01–P 2017. The https://www.regulations.gov
electronic filing system will accept Written/Paper Submissions
comments until midnight Eastern Time Submit written/paper submissions as
DEPARTMENT OF HEALTH AND at the end of August 18, 2017. follows:
HUMAN SERVICES Comments received by mail/hand • Mail/Hand delivery/Courier (for
Food and Drug Administration delivery/courier (for written/paper written/paper submissions): Dockets
submissions) will be considered timely Management Staff (HFA–305), Food and
[Docket No. FDA–2011–N–0076] if they are postmarked or the delivery Drug Administration, 5630 Fishers
service acceptance receipt is on or Lane, Rm. 1061, Rockville, MD 20852.
Agency Information Collection before that date. • For written/paper comments
Activities; Proposed Collection; submitted to the Dockets Management
Comment Request; Electronic Electronic Submissions
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Staff, FDA will post your comment, as
Records; Electronic Signatures Submit electronic comments in the well as any attachments, except for
AGENCY: Food and Drug Administration, following way: information submitted, marked and
HHS. • Federal eRulemaking Portal: identified, as confidential, if submitted
ACTION: Notice. https://www.regulations.gov/. Follow as detailed in ‘‘Instructions.’’
the instructions for submitting Instructions: All submissions received
SUMMARY: The Food and Drug comments. Comments submitted must include the Docket No. FDA–
Administration (FDA) is announcing an electronically, including attachments, to 2011–N–0076 for ‘‘Electronic Records;
opportunity for public comment on the https://www.regulations.gov/ will be Electronic Signatures.’’ Received
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![27840 Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section records per Total hours
recordkeepers records recordkeeping
recordkeeper (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: June 13, 2017. at the end of August 18, 2017. identified, as confidential, if submitted
Anna K. Abram, Comments received by mail/hand as detailed in ‘‘Instructions.’’
Deputy Commissioner for Policy, Planning, delivery/courier (for written/paper Instructions: All submissions received
Legislation, and Analysis. submissions) will be considered timely must include the Docket No. FDA–
[FR Doc. 2017–12619 Filed 6–16–17; 8:45 am] if they are postmarked or the delivery 2014–N–0345 for ‘‘Data to Support Drug
BILLING CODE 4164–01–P service acceptance receipt is on or Product Communications as Used by the
before that date. Food and Drug Administration.’’
Received comments, those filed in a
DEPARTMENT OF HEALTH AND Electronic Submissions timely manner (see ADDRESSES), will be
HUMAN SERVICES Submit electronic comments in the placed in the docket and, except for
following way: those submitted as ‘‘Confidential
Food and Drug Administration • Federal eRulemaking Portal: Submissions,’’ publicly viewable at
[Docket No. FDA–2014–N–0345] https://www.regulations.gov. Follow the https://www.regulations.gov or at the
instructions for submitting comments. Dockets Management Staff between 9
Agency Information Collection Comments submitted electronically, a.m. and 4 p.m., Monday through
Activities; Proposed Collection; including attachments, to https:// Friday.
Comment Request; Data To Support www.regulations.gov will be posted to • Confidential Submissions—To
Drug Product Communications as the docket unchanged. Because your submit a comment with confidential
Used by the Food and Drug comment will be made public, you are information that you do not wish to be
Administration solely responsible for ensuring that your made publicly available, submit your
comments only as a written/paper
AGENCY: Food and Drug Administration, comment does not include any
submission. You should submit two
HHS. confidential information that you or a
copies total. One copy will include the
ACTION: Notice. third party may not wish to be posted,
information you claim to be confidential
such as medical information, your or
with a heading or cover note that states
SUMMARY: The Food and Drug anyone else’s Social Security number, or
‘‘THIS DOCUMENT CONTAINS
Administration (FDA or Agency) is confidential business information, such
CONFIDENTIAL INFORMATION.’’ The
announcing an opportunity for public as a manufacturing process. Please note
Agency will review this copy, including
comment on the proposed collection of that if you include your name, contact
the claimed confidential information, in
certain information by the Agency. information, or other information that
its consideration of comments. The
Under the Paperwork Reduction Act of identifies you in the body of your second copy, which will have the
1995 (PRA), Federal Agencies are comments, that information will be claimed confidential information
required to publish notice in the posted on https://www.regulations.gov. redacted/blacked out, will be available
Federal Register concerning each • If you want to submit a comment for public viewing and posted on
proposed collection of information, with confidential information that you https://www.regulations.gov. Submit
including each proposed extension of an do not wish to be made available to the both copies to the Dockets Management
existing collection of information, and public, submit the comment as a Staff. If you do not wish your name and
to allow 60 days for public comment in written/paper submission and in the contact information to be made publicly
response to the notice. This notice manner detailed (see ‘‘Written/Paper available, you can provide this
solicits comments on a generic Submissions’’ and ‘‘Instructions’’). information on the cover sheet and not
clearance to collect information to in the body of your comments and you
Written/Paper Submissions
support communications used by FDA must identify this information as
about drug products. Submit written/paper submissions as ‘‘confidential.’’ Any information marked
DATES: Submit either electronic or follows: as ‘‘confidential’’ will not be disclosed
written comments on the collection of • Mail/Hand delivery/Courier (for except in accordance with 21 CFR 10.20
information by August 18, 2017. written/paper submissions): Dockets
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and other applicable disclosure law. For
ADDRESSES: You may submit comments Management Staff (HFA–305), Food and more information about FDA’s posting
as follows. Please note that late, Drug Administration, 5630 Fishers of comments to public dockets, see 80
untimely filed comments will not be Lane, Rm. 1061, Rockville, MD 20852. FR 56469, September 18, 2015, or access
considered. Electronic comments must • For written/paper comments the information at: https://www.gpo.gov/
be submitted on or before August 18, submitted to the Dockets Management fdsys/pkg/FR-2015-09-18/pdf/2015-
2017. The https://www.regulations.gov Staff, FDA will post your comment, as 23389.pdf.
electronic filing system will accept well as any attachments, except for Docket: For access to the docket to
comments until midnight Eastern Time information submitted, marked and read background documents or the
VerDate Sep<11>2014 17:09 Jun 16, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1](https://thefederalregister.org/doc/82_FR_27954/page/3.svg)
Document Created: 2017-06-17 01:48:32
Document Modified: 2017-06-17 01:48:32
| 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 | Submit either electronic or written comments on the collection of information by August 18, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 27838 |
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