83 FR 48619 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 187 (September 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48619-48620 | |
| FR Document | 2018-20909 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48619-48620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20909] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-2138] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 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 October 26, 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 [email protected]. All comments should be identified with the OMB control number 0910-0800. 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, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA [[Page 48620]] has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0800--Extension This information collection supports Agency implementation of the Drug Quality and Security Act (Pub. L. 113-54), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding new section 503B (21 U.S.C. 353b). Under section 503B(b) of the FD&C Act, a compounder can register as an outsourcing facility with FDA. If the conditions outlined in section 503B(a) of the FD&C Act are satisfied, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from certain sections of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under Sec. 310.305 (21 CFR 310.305) (or any successor regulations). Accordingly, we developed the document, ``Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' For a copy of guidance documents, go to https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, insert the title of the guidance document in the ``Search'' box and follow the prompts. The guidance explains electronic reporting of adverse events in accordance with Sec. 310.305 with respect to outsourcing facilities. Under Sec. 310.305(c)(1), manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved NDA or ANDA, including, as set forth in the guidance, outsourcing facilities must submit to FDA adverse event reports within 15 calendar days of receiving the information and must submit follow-up reports within 15 calendar days of receipt of new information about the adverse event, or as requested by FDA. Outsourcing facilities must submit the adverse event report in an electronic format that FDA can process, review, and archive (collection of information is approved by OMB control number 0910-0291). A copy of the current labeling of the compounded drug product must be provided. Under Sec. 310.305(f), entities subject to the regulation must maintain for 10 years the records of all adverse events required to be reported under Sec. 310.305. The outsourcing facility should also maintain records of its efforts to obtain the data elements described in the draft guidance for each adverse event report. In the Federal Register of August 21, 2018 (83 FR 28854), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden for the information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Compounding outsourcing facility Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of adverse event reports' including copy of labeling and 55 1 55 1.1 61 other information as described in the guidance.................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of recordkeeping Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Records of adverse events, including records of efforts to obtain 55 1 55 16 880 the data elements for each adverse event report................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. This is the first extension of the information collection and we have retained the currently approved burden estimate. Based on our review of Agency data, we estimate that annually 55 outsourcing facilities (``Number of Respondents'' and ``Total Annual Responses'' in table 1) will submit adverse event reports to FDA as specified in the guidance and that preparing and submitting this information will take approximately 1.1 hours per registrant (``Average Burden per Response'' in table 1). Likewise, we estimate that annually 55 outsourcing facilities (``Number of Recordkeepers'' in table 2) will maintain records of adverse events as specified in the guidance and that preparing and maintaining the records will take approximately 16 hours per registrant (``Average Burden per Recordkeeping'' in table 2). Dated: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20909 Filed 9-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48619
TABLE 1—MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW SCHEDULE FOR FY 2019
Fee rate for
Fee category FY 2019
Application submitted with a material threat MCM priority review voucher in addition to the normal PDUFA fee ............................ $2,457,140
IV. Implementation of Material Threat If paying with a paper check, the user RA/Documents/HA2006_Ridley_
Medical Countermeasure Priority fee identification (ID) number should be Vouchers.pdf.
Review User Fee included on the check, followed by the Dated: September 20, 2018.
words ‘‘Material Threat Medical Leslie Kux,
Under section 565A(c)(4)(A) of the Countermeasure Priority Review.’’ All Associate Commissioner for Policy.
FD&C Act, the priority review user fee paper checks must be in U.S. currency [FR Doc. 2018–20910 Filed 9–25–18; 8:45 am]
is due upon submission of a human from a U.S. bank made payable and
BILLING CODE 4164–01–P
drug application for which the priority mailed to: Food and Drug
review voucher is used. Section Administration, P.O. Box 979107, St.
565A(c)(4)(B) of the FD&C Act specifies Louis, MO 63197–9000. DEPARTMENT OF HEALTH AND
that the application will be considered If checks are sent by a courier that HUMAN SERVICES
incomplete if the priority review user requests a street address, the courier can
fee and all other applicable user fees are deliver the checks to: U.S. Bank, Food and Drug Administration
not paid in accordance with FDA Attention: Government Lockbox 979107,
payment procedures. In addition, [Docket No. FDA–2014–D–2138]
1005 Convention Plaza, St. Louis, MO
section 565A(c)(4)(C) specifies that FDA 63101. (Note: This U.S. Bank address is Agency Information Collection
may not grant a waiver, exemption, for courier delivery only. If you have Activities; Submission for Office of
reduction, or refund of any fees due and any questions concerning courier Management and Budget Review;
payable under this section of the FD&C delivery, contact the U.S. Bank at 314– Comment Request; Guidance for
Act. 418–4013. This telephone number is Industry: Adverse Event Reporting for
The material threat MCM priority only for questions about courier Outsourcing Facilities Under Section
review fee established in the new fee delivery). The FDA post office box 503B of the Federal Food, Drug, and
schedule must be paid for any number (P.O. Box 979107) must be Cosmetic Act
application that is received on or after written on the check. If needed, FDA’s
October 1, 2018, and submitted with a tax identification number is 53– AGENCY: Food and Drug Administration,
priority review voucher. This fee must 0196965. HHS.
be paid in addition to any other fee due If paying by wire transfer, please ACTION: Notice.
under PDUFA. Payment must be made reference your unique user fee ID
number when completing your transfer. SUMMARY: The Food and Drug
in U.S. currency by electronic check, Administration (FDA) is announcing
check, bank draft, wire transfer, credit The originating financial institution
may charge a wire transfer fee. If the that a proposed collection of
card, or U.S. postal money order information has been submitted to the
payable to the order of the Food and financial institution charges a wire
transfer fee, it is required to add that Office of Management and Budget
Drug Administration. The preferred (OMB) for review and clearance under
payment method is online using amount to the payment to ensure that
the invoice is paid in full. The account the Paperwork Reduction Act of 1995.
electronic check (Automated Clearing
information is as follows: U.S. Dept. of DATES: Fax written comments on the
House (ACH) also known as eCheck).
Secure electronic payments can be Treasury, TREAS NYC, 33 Liberty St., collection of information by October 26,
submitted using the User Fees Payment New York, NY 10045, Account Number: 2018.
Portal at https://userfees.fda.gov/pay. 75060099, Routing Number: 021030004, ADDRESSES: To ensure that comments on
(Note: Only full payments are accepted. SWIFT: FRNYUS33. the information collection are received,
No partial payments can be made OMB recommends that written
V. Reference
online.) Once you search for your comments be faxed to the Office of
The following reference is on display Information and Regulatory Affairs,
invoice, select ‘‘Pay Now’’ to be
at the Dockets Management Staff (HFA– OMB, Attn: FDA Desk Officer, Fax: 202–
redirected to https://www.pay.gov/
305), Food and Drug Administration, 395–7285, or emailed to oira_
public/home. Note that electronic
5630 Fishers Lane, Rm. 1061, Rockville, submission@omb.eop.gov. All
payment options are based on the
MD 20852) and is available for viewing comments should be identified with the
balance due. Payment by credit card is
by interested persons between 9 a.m. OMB control number 0910–0800. Also
available for balances that are less than
and 4 p.m., Monday through Friday; it include the FDA docket number found
$25,000. If the balance exceeds this
is not available electronically at https:// in brackets in the heading of this
amount, only the ACH option is
www.regulations.gov as this reference is document.
available. Payments must be made using
copyright protected. FDA has verified
U.S. bank accounts as well as U.S. credit FOR FURTHER INFORMATION CONTACT:
the website address, as of the date this
cards. Domini Bean, Office of Operations,
document publishes in the Federal
daltland on DSKBBV9HB2PROD with NOTICES
FDA has partnered with the U.S. Food and Drug Administration, Three
Register, but websites are subject to
Department of the Treasury to use White Flint North, 10A–12M, 11601
change over time.
Pay.gov, a web-based payment Landsdown St., North Bethesda, MD
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, 20852, 301–796–5733, PRAStaff@
application, for online electronic ‘‘Developing Drugs for Developing
payment. The Pay.gov feature is fda.hhs.gov.
Countries,’’ Health Affairs, vol. 25, no. 2,
available on the FDA website after the pp. 313–324, 2006, available at: https:// SUPPLEMENTARY INFORMATION: In
user fee ID number is generated. faculty.fuqua.duke.edu/∼willm/HSM_ compliance with 44 U.S.C. 3507, FDA
VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1](https://thefederalregister.org/doc/83_FR_48806/page/1.svg)
![48620 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
has submitted the following proposed applications (ANDAs)). Drugs guidance, outsourcing facilities must
collection of information to OMB for compounded in outsourcing facilities submit to FDA adverse event reports
review and clearance. are not exempt from the requirements of within 15 calendar days of receiving the
section 501(a)(2)(B) of the FD&C Act (21 information and must submit follow-up
Guidance for Industry: Adverse Event
U.S.C. 351(a)(2)(B)) (concerning current reports within 15 calendar days of
Reporting for Outsourcing Facilities
Under Section 503B of the Federal good manufacturing practice for drugs). receipt of new information about the
Food, Drug, and Cosmetic Act Under section 503B(b)(5) of the FD&C adverse event, or as requested by FDA.
Act, an outsourcing facility must submit Outsourcing facilities must submit the
OMB Control Number 0910–0800— adverse event reports to FDA in adverse event report in an electronic
Extension accordance with the content and format format that FDA can process, review,
This information collection supports requirements established through and archive (collection of information is
Agency implementation of the Drug guidance or regulation under § 310.305 approved by OMB control number
Quality and Security Act (Pub. L. 113– (21 CFR 310.305) (or any successor 0910–0291). A copy of the current
54), which amended the Federal Food, regulations). Accordingly, we developed labeling of the compounded drug
Drug, and Cosmetic Act (FD&C Act) by the document, ‘‘Guidance for Industry: product must be provided.
adding new section 503B (21 U.S.C. Adverse Event Reporting for Under § 310.305(f), entities subject to
353b). Under section 503B(b) of the Outsourcing Facilities Under Section the regulation must maintain for 10
FD&C Act, a compounder can register as 503B of the Federal Food, Drug, and years the records of all adverse events
an outsourcing facility with FDA. If the Cosmetic Act.’’ For a copy of guidance required to be reported under § 310.305.
conditions outlined in section 503B(a) documents, go to https://www.fda.gov/ The outsourcing facility should also
of the FD&C Act are satisfied, a drug RegulatoryInformation/Guidances/ maintain records of its efforts to obtain
compounded by or under the direct default.htm, insert the title of the the data elements described in the draft
supervision of a licensed pharmacist in guidance document in the ‘‘Search’’ box guidance for each adverse event report.
an outsourcing facility is exempt from and follow the prompts. The guidance
certain sections of the FD&C Act, explains electronic reporting of adverse In the Federal Register of August 21,
including section 502(f)(1) (21 U.S.C. events in accordance with § 310.305 2018 (83 FR 28854), we published a 60-
352(f)(1)) (concerning the labeling of with respect to outsourcing facilities. day notice requesting public comment
drugs with adequate directions for use) Under § 310.305(c)(1), manufacturers, on the proposed collection of
and section 505 (21 U.S.C. 355) packers, and distributors of marketed information. No comments were
(concerning the approval of human drug prescription drug products that are not received.
products under new drug applications the subject of an approved NDA or We estimate the burden for the
(NDAs) or abbreviated new drug ANDA, including, as set forth in the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Compounding outsourcing facility responses per burden per Total hours
respondents responses
respondent response
Submission of adverse event reports’ including copy of la-
beling and other information as described in the guid-
ance .................................................................................. 55 1 55 1.1 61
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Type of recordkeeping records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Records of adverse events, including records of efforts to
obtain the data elements for each adverse event report 55 1 55 16 880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the estimate that annually 55 outsourcing Dated: September 20, 2018.
information collection and we have facilities (‘‘Number of Recordkeepers’’ Leslie Kux,
retained the currently approved burden in table 2) will maintain records of Associate Commissioner for Policy.
estimate. Based on our review of Agency adverse events as specified in the [FR Doc. 2018–20909 Filed 9–25–18; 8:45 am]
data, we estimate that annually 55 guidance and that preparing and BILLING CODE 4164–01–P
outsourcing facilities (‘‘Number of maintaining the records will take
Respondents’’ and ‘‘Total Annual approximately 16 hours per registrant
daltland on DSKBBV9HB2PROD with NOTICES
Responses’’ in table 1) will submit (‘‘Average Burden per Recordkeeping’’
adverse event reports to FDA as in table 2).
specified in the guidance and that
preparing and submitting this
information will take approximately 1.1
hours per registrant (‘‘Average Burden
per Response’’ in table 1). Likewise, we
VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 9990 E:\FR\FM\26SEN1.SGM 26SEN1](https://thefederalregister.org/doc/83_FR_48806/page/2.svg)
Document Created: 2018-09-26 00:47:13
Document Modified: 2018-09-26 00:47:13
| 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 October 26, 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 48619 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR