83 FR 5784 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5784-5785 | |
| FR Document | 2018-02589 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Pages 5784-5785] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02589] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0334] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements 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 March 12, 2018. 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 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0770. 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, 301-796-5733, PRAStaff@fda.hhs.gov. 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. Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements OMB Control Number 0910-0770--Extension This information collection supports information collection found in FDA regulations. In the Federal Register of June 10, 2014 (79 FR 33072), FDA published a final rule entitled ``Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements.'' The final rule amended FDA's postmarketing safety reporting regulations for human drug and biological products under 21 CFR parts 310, 314, and 600 and added part 329 to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. Specifically, this includes:Manufacturers; packers; distributors; applicants with approved new drug applications, abbreviated new drug applications, and biologics licensing applications (BLAs); and those that market prescription drugs for human use without an approved application must submit postmarketing safety reports to the Agency (Sec. Sec. 310.305, 314.80, 314.98, and 600.80); manufacturers, packers, or distributors whose name appears on the label of nonprescription human drug products marketed without an approved application must report serious adverse events associated with their products (section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379aa)); and applicants with approved BLAs must submit biological lot distribution reports to the Agency (Sec. 600.81). Under Sec. Sec. 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2), of the regulations, those who are subject to these postmarketing safety reporting requirements may request a waiver from the electronic format requirement. While FDA currently has OMB approval for the collection of postmarketing safety reports,\1\ this information collection supports respondents seeking waivers from submitting those reports in electronic format as required by the regulations. --------------------------------------------------------------------------- \1\ FDA currently has OMB approval for submission of postmarketing safety reports under parts 310, 314, and 600. The information collection for parts 310 and 314 is approved under OMB Control Numbers 0910-0291 and 0910-0230. The information collection for part 600 is approved under OMB Control Numbers 0910-0291 and 0910-0308. Submissions required by section 760 of the FD&C Act have been approved under OMB Control Number 0910-0636. --------------------------------------------------------------------------- In the Federal Register of October 30, 2017 (82 FR 50141), 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 notice. We therefore estimate the burden of this collection of information as follows: [[Page 5785]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 310.305(e)(2)................... 1 1 1 1 1 314.80(g)(2).................... 5 1 5 1 5 329.100(c)(2)................... 1 1 1 1 1 600.80(h)(2).................... 5 1 5 1 5 600.81(b)(2).................... 1 1 1 1 1 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 13 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital or operating and maintenance costs associated with this collection of information. In table 1, we estimate the burden associated with the submission of waiver requests for postmarketing safety reports in electronic format under Sec. Sec. 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2). We expect few waiver requests. We estimate only one manufacturer will request a waiver annually under Sec. Sec. 310.305(e)(2), 329.100(c)(2), and 600.81(b)(2), and approximately five manufacturers will request waivers annually under Sec. Sec. 314.80(g)(2) and 600.80(h)(2). We estimate that each waiver request takes 1 hour to prepare and submit. The burden for this information collection has not increased since the last collection. Dated: February 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02589 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
![5784 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of Total
21 CFR section responses per annual burden per
respondents hours
respondent responses response
10.75, Request for review of a scientific dispute ................ 1 4 4 10 40
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In the next 3 years, CVM anticipates DATES: Fax written comments on the to require that persons subject to
receiving one or fewer requests for collection of information by March 12, mandatory reporting requirements
review of a scientific dispute per year, 2018. submit safety reports in an electronic
on average. We base our estimate on ADDRESSES: To ensure that comments on format that FDA can process, review,
CVM’s experience over the past 6 years the information collection are received, and archive. Specifically, this includes:
in handling formal appeals for scientific OMB recommends that written • Manufacturers; packers;
disputes. The burden of this collection comments be faxed to the Office of distributors; applicants with approved
has changed. The number of Information and Regulatory Affairs, new drug applications, abbreviated new
respondents decreased from two to one OMB, Attn: FDA Desk Officer, Fax: 202– drug applications, and biologics
annually, the number of responses per 395–7285, or emailed to oira_ licensing applications (BLAs); and those
respondent remained at four annually, submission@omb.eop.gov. All that market prescription drugs for
the hours per response remained at 10 comments should be identified with the human use without an approved
annually, and the total number of hours OMB control number 0910–0770. Also application must submit postmarketing
decreased from 80 to 40. This decrease include the FDA docket number found safety reports to the Agency (§§ 310.305,
in the total hours is the result of a in brackets in the heading of this 314.80, 314.98, and 600.80);
natural fluctuation in the number of document. • manufacturers, packers, or
respondents taking advantage of this distributors whose name appears on the
dispute resolution process. FOR FURTHER INFORMATION CONTACT:
label of nonprescription human drug
Domini Bean, Office of Operations,
Dated: February 5, 2018. products marketed without an approved
Food and Drug Administration, Three
Leslie Kux, application must report serious adverse
White Flint North, 10A–12M, 11601
Associate Commissioner for Policy. events associated with their products
Landsdown St., North Bethesda, MD
[FR Doc. 2018–02593 Filed 2–8–18; 8:45 am] (section 760 of the Federal Food, Drug,
20852, 301–796–5733, PRAStaff@
and Cosmetic Act (FD&C Act) (21 U.S.C.
BILLING CODE 4164–01–P fda.hhs.gov.
379aa)); and
SUPPLEMENTARY INFORMATION: In • applicants with approved BLAs
DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA must submit biological lot distribution
HUMAN SERVICES has submitted the following proposed reports to the Agency (§ 600.81).
collection of information to OMB for Under §§ 310.305(e)(2), 314.80(g)(2),
Food and Drug Administration review and clearance. 329.100(c)(2), 600.80(h)(2), and
[Docket No. FDA–2008–N–0334] Postmarketing Safety Reports for 600.81(b)(2), of the regulations, those
Human Drug and Biological Products: who are subject to these postmarketing
Agency Information Collection Waivers From Electronic Submission safety reporting requirements may
Activities; Submission for Office of Requirements request a waiver from the electronic
Management and Budget Review; format requirement. While FDA
Comment Request; Postmarketing OMB Control Number 0910–0770— currently has OMB approval for the
Safety Reports for Human Drug and Extension collection of postmarketing safety
Biological Products: Electronic This information collection supports reports,1 this information collection
Submission Requirements information collection found in FDA supports respondents seeking waivers
AGENCY: Food and Drug Administration, regulations. In the Federal Register of from submitting those reports in
HHS. June 10, 2014 (79 FR 33072), FDA electronic format as required by the
published a final rule entitled regulations.
ACTION: Notice.
‘‘Postmarketing Safety Reports for In the Federal Register of October 30,
SUMMARY: The Food and Drug Human Drug and Biological Products: 2017 (82 FR 50141), we published a 60-
Administration (FDA) is announcing Electronic Submission Requirements.’’ day notice requesting public comment
that a proposed collection of The final rule amended FDA’s on the proposed extension of this
information has been submitted to the postmarketing safety reporting collection of information. No comments
Office of Management and Budget regulations for human drug and were received in response to the notice.
(OMB) for review and clearance under biological products under 21 CFR parts We therefore estimate the burden of
the Paperwork Reduction Act of 1995. 310, 314, and 600 and added part 329 this collection of information as follows:
sradovich on DSK3GMQ082PROD with NOTICES
1 FDA currently has OMB approval for Control Numbers 0910–0291 and 0910–0230. The FD&C Act have been approved under OMB Control
submission of postmarketing safety reports under information collection for part 600 is approved Number 0910–0636.
parts 310, 314, and 600. The information collection under OMB Control Numbers 0910–0291 and 0910–
for parts 310 and 314 is approved under OMB 0308. Submissions required by section 760 of the
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![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5785
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR section responses per burden per
respondents responses hours
respondent response
310.305(e)(2) ....................................................................... 1 1 1 1 1
314.80(g)(2) ......................................................................... 5 1 5 1 5
329.100(c)(2) ........................................................................ 1 1 1 1 1
600.80(h)(2) ......................................................................... 5 1 5 1 5
600.81(b)(2) ......................................................................... 1 1 1 1 1
Total .............................................................................. ........................ ........................ ........................ ........................ 13
1 There are no capital or operating and maintenance costs associated with this collection of information.
In table 1, we estimate the burden Recommendations for Specific • Mail/Hand delivery/Courier (for
associated with the submission of Products’’ that explained the process written/paper submissions): Dockets
waiver requests for postmarketing safety that would be used to make product- Management Staff (HFA–305), Food and
reports in electronic format under specific guidances available to the Drug Administration, 5630 Fishers
§§ 310.305(e)(2), 314.80(g)(2), public on FDA’s website. The guidances Lane, Rm. 1061, Rockville, MD 20852.
329.100(c)(2), 600.80(h)(2), and identified in this notice were developed • For written/paper comments
600.81(b)(2). We expect few waiver using the process described in that submitted to the Dockets Management
requests. We estimate only one guidance. Staff, FDA will post your comment, as
manufacturer will request a waiver well as any attachments, except for
annually under §§ 310.305(e)(2), DATES: Submit either electronic or information submitted, marked and
329.100(c)(2), and 600.81(b)(2), and written comments on the draft guidance identified, as confidential, if submitted
approximately five manufacturers will by April 10, 2018 to ensure that the as detailed in ‘‘Instructions.’’
request waivers annually under Agency considers your comment on this Instructions: All submissions received
§§ 314.80(g)(2) and 600.80(h)(2). We draft guidance before it begins work on must include the Docket No. FDA–
estimate that each waiver request takes the final version of the guidance. 2007–D–0369 for ‘‘Product-Specific
1 hour to prepare and submit. The ADDRESSES: You may submit comments Guidances; Draft and Revised Draft
burden for this information collection on any guidance at any time as follows: Guidances for Industry.’’ Received
has not increased since the last comments will be placed in the docket
Electronic Submissions and, except for those submitted as
collection.
Submit electronic comments in the ‘‘Confidential Submissions,’’ publicly
Dated: February 5, 2018. viewable at https://www.regulations.gov
Leslie Kux,
following way:
or at the Dockets Management Staff
Associate Commissioner for Policy. • Federal eRulemaking Portal:
between 9 a.m. and 4 p.m., Monday
https://www.regulations.gov. Follow the
[FR Doc. 2018–02589 Filed 2–8–18; 8:45 am] through Friday.
instructions for submitting comments. • Confidential Submissions—To
BILLING CODE 4164–01–P
Comments submitted electronically, submit a comment with confidential
including attachments, to https:// information that you do not wish to be
DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to made publicly available, submit your
HUMAN SERVICES the docket unchanged. Because your comments only as a written/paper
comment will be made public, you are submission. You should submit two
Food and Drug Administration solely responsible for ensuring that your copies total. One copy will include the
comment does not include any information you claim to be confidential
[Docket No. FDA–2007–D–0369] confidential information that you or a with a heading or cover note that states
third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
Product-Specific Guidances; Draft and such as medical information, your or
Revised Draft Guidances for Industry; CONFIDENTIAL INFORMATION.’’ The
anyone else’s Social Security number, or Agency will review this copy, including
Availability confidential business information, such the claimed confidential information, in
AGENCY: Food and Drug Administration, as a manufacturing process. Please note its consideration of comments. The
HHS. that if you include your name, contact second copy, which will have the
information, or other information that claimed confidential information
ACTION: Notice of availability.
identifies you in the body of your redacted/blacked out, will be available
SUMMARY: The Food and Drug comments, that information will be for public viewing and posted on
Administration (FDA or Agency) is posted on https://www.regulations.gov. https://www.regulations.gov. Submit
announcing the availability of • If you want to submit a comment both copies to the Dockets Management
additional draft and revised draft with confidential information that you Staff. If you do not wish your name and
product-specific guidances. The do not wish to be made available to the contact information to be made publicly
guidances provide product-specific public, submit the comment as a available, you can provide this
sradovich on DSK3GMQ082PROD with NOTICES
recommendations on, among other written/paper submission and in the information on the cover sheet and not
things, the design of bioequivalence manner detailed (see ‘‘Written/Paper in the body of your comments and you
(BE) studies to support abbreviated new Submissions’’ and ‘‘Instructions’’). must identify this information as
drug applications (ANDAs). In the ‘‘confidential.’’ Any information marked
Written/Paper Submissions
Federal Register of June 11, 2010, FDA as ‘‘confidential’’ will not be disclosed
announced the availability of a guidance Submit written/paper submissions as except in accordance with 21 CFR 10.20
for industry entitled ‘‘Bioequivalence follows: and other applicable disclosure law. For
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Document Created: 2018-02-09 00:11:47
Document Modified: 2018-02-09 00:11:47
| 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 March 12, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 5784 |
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