82 FR 13822 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 49 (March 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13822-13823 | |
| FR Document | 2017-05100 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13822-13823] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05100] [[Page 13822]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0719] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 (PRA). DATES: Fax written comments on the collection of information by April 14, 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 0910-0675. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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. Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products OMB Control Number 0910-0675--Extension The guidance recommends that manufacturers of drug and therapeutic biological products and manufacturers of raw materials and components used in those products develop a written Emergency Plan (Plan) for maintaining an adequate supply of medically necessary drug products (MNPs) during an emergency that results in high employee absenteeism. The guidance discusses the issues that should be covered by the Plan, such as: (1) Identifying a person or position title (as well as two designated alternates) with the authority to activate and deactivate the Plan and make decisions during the emergency; (2) prioritizing the manufacturer's drug products based on medical necessity; (3) identifying actions that should be taken prior to an anticipated period of high absenteeism; (4) identifying criteria for activating the Plan; (5) performing quality risk assessments to determine which manufacturing activities may be reduced to enable the company to meet a demand for MNPs; (6) returning to normal operations and conducting a post-execution assessment of the execution outcomes; and (7) testing the Plan. The guidance recommends developing a Plan for each individual manufacturing facility as well as a broader Plan that addresses multiple sites within the organization. For purposes of this information collection analysis, we consider the Plan for an individual manufacturing facility as well as the broader Plan to comprise one Plan for each manufacturer. Based on FDA's data on the number of manufacturers that would be covered by the guidance, we estimate that approximately 70 manufacturers will develop a Plan as recommended by the guidance (i.e., one Plan per manufacturer to include all manufacturing facilities, sites, and drug products), and that each Plan will take approximately 500 hours to develop, maintain, and update. The guidance also encourages manufacturers to include a procedure in their Plan for notifying the Center for Drug Evaluation and Research (CDER) when the Plan is activated and when returning to normal operations. The guidance recommends that these notifications occur within 1 day of a Plan's activation and within 1 day of a Plan's deactivation. The guidance specifies the information that should be included in these notifications, such as which drug products will be manufactured under altered procedures, which products will have manufacturing temporarily delayed, and any anticipated or potential drug shortages. We expect that approximately two notifications (for purposes of this analysis, we consider an activation and a deactivation notification to equal one notification) will be sent to CDER by approximately two manufacturers each year, and that each notification will take approximately 16 hours to prepare and submit. The guidance also refers to previously approved collections of information found in FDA regulations. Under the guidance, if a manufacturer obtains information after releasing an MNP under its Plan leading to suspicion that the product might be defective, CDER should be contacted immediately at [email protected] in adherence to existing recall reporting regulations (21 CFR 7.40) (OMB control number 0910-0249), or defect reporting requirements for drug application products (21 CFR 314.81(b)(1)) and therapeutic biological products regulated by CDER (21 CFR 600.14) (OMB control numbers 0910-0001 and 0910-0458, respectively). In addition, the following collections of information found in FDA current good manufacturing practice (CGMP) regulations in part 211 (21 CFR part 211) are approved under OMB control number 0190-0139. The guidance encourages manufacturers to maintain records, in accordance with the CGMP requirements (see, e.g., Sec. 211.180) that support decisions to carry out changes to approved procedures for manufacturing and release of products under the Plan. The guidance states that a Plan should be developed, written, reviewed, and approved within the site's change control quality system in accordance with the requirements in Sec. Sec. 211.100(a) and 211.160(a); execution of the Plan should be documented in accordance with the requirements described in Sec. 211.100(b); and standard operating procedures should be reviewed and revised or supplementary procedures developed and approved to enable execution of the Plan. In the Federal Register of November 3, 2016 (81 FR 76618), 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 estimate the burden of this information collection as follows: [[Page 13823]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Absenteeism guidance Number of responses per Total annual Average burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- Notify FDA of Plan Activation and Deactivation...... 2 1 2 16 32 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 Number of records Total annual Average burden per Absenteeism guidance recordkeepers per recordkeeper records recordkeeping Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Develop Initial Plan................................ 70 1 70 500 35,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05100 Filed 3-14-17; 8:45 am] BILLING CODE 4164-01-P
![13822 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
DEPARTMENT OF HEALTH AND of raw materials and components used any anticipated or potential drug
HUMAN SERVICES in those products develop a written shortages. We expect that approximately
Emergency Plan (Plan) for maintaining two notifications (for purposes of this
Food and Drug Administration an adequate supply of medically analysis, we consider an activation and
[Docket No. FDA–2013–N–0719] necessary drug products (MNPs) during a deactivation notification to equal one
an emergency that results in high notification) will be sent to CDER by
Agency Information Collection employee absenteeism. The guidance approximately two manufacturers each
Activities; Submission for Office of discusses the issues that should be year, and that each notification will take
Management and Budget Review; covered by the Plan, such as: (1) approximately 16 hours to prepare and
Comment Request; Guidance for Identifying a person or position title (as submit.
Industry on Planning for the Effects of well as two designated alternates) with
The guidance also refers to previously
High Absenteeism To Ensure the authority to activate and deactivate
approved collections of information
Availability of Medically Necessary the Plan and make decisions during the
found in FDA regulations. Under the
Drug Products emergency; (2) prioritizing the
guidance, if a manufacturer obtains
manufacturer’s drug products based on
AGENCY: Food and Drug Administration, medical necessity; (3) identifying information after releasing an MNP
HHS. actions that should be taken prior to an under its Plan leading to suspicion that
ACTION: Notice. anticipated period of high absenteeism; the product might be defective, CDER
(4) identifying criteria for activating the should be contacted immediately at
SUMMARY: The Food and Drug Plan; (5) performing quality risk drugshortages@fda.hhs.gov in
Administration (FDA or we) is assessments to determine which adherence to existing recall reporting
announcing that a proposed collection manufacturing activities may be regulations (21 CFR 7.40) (OMB control
of information has been submitted to the reduced to enable the company to meet number 0910–0249), or defect reporting
Office of Management and Budget a demand for MNPs; (6) returning to requirements for drug application
(OMB) for review and clearance under normal operations and conducting a products (21 CFR 314.81(b)(1)) and
the Paperwork Reduction Act of 1995 post-execution assessment of the therapeutic biological products
(PRA). execution outcomes; and (7) testing the regulated by CDER (21 CFR 600.14)
DATES: Fax written comments on the Plan. The guidance recommends (OMB control numbers 0910–0001 and
collection of information by April 14, developing a Plan for each individual 0910–0458, respectively).
2017. manufacturing facility as well as a In addition, the following collections
ADDRESSES: To ensure that comments on
broader Plan that addresses multiple of information found in FDA current
the information collection are received, sites within the organization. For good manufacturing practice (CGMP)
OMB recommends that written purposes of this information collection regulations in part 211 (21 CFR part
comments be faxed to the Office of analysis, we consider the Plan for an 211) are approved under OMB control
Information and Regulatory Affairs, individual manufacturing facility as number 0190–0139. The guidance
OMB, Attn: FDA Desk Officer, FAX: well as the broader Plan to comprise one encourages manufacturers to maintain
202–395–7285, or emailed to oira_ Plan for each manufacturer. Based on records, in accordance with the CGMP
submission@omb.eop.gov. All FDA’s data on the number of requirements (see, e.g., § 211.180) that
manufacturers that would be covered by support decisions to carry out changes
comments should be identified with the
the guidance, we estimate that to approved procedures for
OMB control number 0910–0675. Also
approximately 70 manufacturers will manufacturing and release of products
include the FDA docket number found
develop a Plan as recommended by the under the Plan. The guidance states that
in brackets in the heading of this
guidance (i.e., one Plan per a Plan should be developed, written,
document.
manufacturer to include all reviewed, and approved within the
FOR FURTHER INFORMATION CONTACT: FDA manufacturing facilities, sites, and drug site’s change control quality system in
PRA Staff, Office of Operations, Food products), and that each Plan will take accordance with the requirements in
and Drug Administration, Three White approximately 500 hours to develop, §§ 211.100(a) and 211.160(a); execution
Flint North, 10A63, 11601 Landsdown maintain, and update. of the Plan should be documented in
St., North Bethesda, MD 20852, The guidance also encourages accordance with the requirements
PRAStaff@fda.hhs.gov. manufacturers to include a procedure in described in § 211.100(b); and standard
SUPPLEMENTARY INFORMATION: In their Plan for notifying the Center for operating procedures should be
compliance with 44 U.S.C. 3507, FDA Drug Evaluation and Research (CDER) reviewed and revised or supplementary
has submitted the following proposed when the Plan is activated and when procedures developed and approved to
collection of information to OMB for returning to normal operations. The enable execution of the Plan.
review and clearance. guidance recommends that these
notifications occur within 1 day of a In the Federal Register of November
Guidance for Industry on Planning for Plan’s activation and within 1 day of a 3, 2016 (81 FR 76618), we published a
the Effects of High Absenteeism To Plan’s deactivation. The guidance 60-day notice requesting public
Ensure Availability of Medically specifies the information that should be comment on the proposed extension of
Necessary Drug Products OMB Control included in these notifications, such as this collection of information. No
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
Number 0910–0675—Extension which drug products will be comments were received in response to
The guidance recommends that manufactured under altered procedures, the notice.
manufacturers of drug and therapeutic which products will have We estimate the burden of this
biological products and manufacturers manufacturing temporarily delayed, and information collection as follows:
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![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13823
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Absenteeism guidance responses per Total hours
respondents responses per response
respondent
Notify FDA of Plan Activation and De-
activation ............................................ 2 1 2 16 32
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 Number of records Total annual Average burden
Absenteeism guidance Total hours
recordkeepers per recordkeeper records per recordkeeping
Develop Initial Plan ................................ 70 1 70 500 35,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017. ADDRESSES: Sheraton College Park North Written/Paper Submissions
Leslie Kux, Hotel, Chesapeake Ballroom, 4095 Submit written/paper submissions as
Associate Commissioner for Policy. Powder Mill Road, Beltsville, MD follows:
[FR Doc. 2017–05100 Filed 3–14–17; 8:45 am] 20705. The hotel’s telephone number is • Mail/Hand delivery/Courier (for
BILLING CODE 4164–01–P 301–937–4422. Answers to commonly written/paper submissions): Division of
asked questions including information Dockets Management (HFA–305), Food
regarding special accommodations due and Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND to a disability, visitor parking, and Lane, Rm. 1061, Rockville, MD 20852.
HUMAN SERVICES transportation may be accessed at: • For written/paper comments
http://www.fda.gov/ submitted to the Division of Dockets
Food and Drug Administration Management, FDA will post your
AdvisoryCommittees/
[Docket No. FDA–2017–N–1063] AboutAdvisoryCommittees/ comment, as well as any attachments,
ucm408555.htm. except for information submitted,
Oncologic Drugs Advisory Committee; marked and identified, as confidential,
Notice of Meeting; Establishment of a You may submit comments as if submitted as detailed in
Public Docket; Request for Comments follows: ‘‘Instructions.’’
Instructions: All submissions received
AGENCY: Food and Drug Administration, Electronic Submissions
must include the Docket No. FDA–
HHS. Submit electronic comments in the 2017–N–1063 for ‘‘Oncologic Drugs
ACTION: Notice; establishment of a following way: Advisory Committee; Notice of Meeting;
public docket; request for comments. Establishment of a Public Docket;
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SUMMARY: The Food and Drug https://www.regulations.gov. Follow the comments, those filed in a timely
Administration (FDA) announces a instructions for submitting comments. manner (see DATES), will be placed in
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Submit either electronic or written confidential business information, such comments only as a written/paper
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Document Created: 2017-03-15 06:04:07
Document Modified: 2017-03-15 06:04:07
| 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 April 14, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 13822 |
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