83 FR 8284 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 38 (February 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 38 (February 26, 2018)
| Page Range | 8284-8286 | |
| FR Document | 2018-03847 |
[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)] [Notices] [Pages 8284-8286] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03847] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6175] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations 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 28, 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 0910-0249. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [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. FDA Recall Regulations--21 CFR Part 7 OMB Control Number 0910-0249--Extension Section 701 of the Federal Food, Drug, and Cosmetic Act charges the Secretary of Health and Human Services, through FDA, with the responsibility of assuring recalls (21 U.S.C. 371, Regulations and Hearings, and 21 CFR part 7, Enforcement Policy, Subpart C, Recalls (Including Product Corrections)--Guidance on Policy, Procedures, and Industry Responsibilities which pertain to the recall regulations and provide guidance to manufacturers on recall responsibilities). The regulations and guidance apply to all FDA-regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). These responsibilities of companies conducting recalls include providing FDA with complete details of the recall including: (1) Reason(s) for the removal or correction, risk evaluation, quantity produced, distribution information, firm's recall strategy, a copy of any recall communication(s), and a contact official (Sec. 7.46); (2) notifying direct accounts of the recall, providing guidance regarding further distribution, giving instructions as to what to do with [[Page 8285]] the product, providing recipients with a ready means of reporting to the recalling firm (Sec. 7.49); and (3) submitting periodic status reports so that FDA may assess the progress of the recall. Status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks and product returns (Sec. 7.53), and providing the opportunity for a firm to request in writing that FDA terminate the recall (Sec. 7.55(b)). A search of the FDA database was performed to determine the number of recalls that took place during fiscal years 2014 to 2016. The resulting number of total recalls and terminations (8,560) from this database search were then averaged over the 3 years, and the resulting per year average of recalls and terminations (2,853) are used in estimating the current annual reporting and third party disclosure burden in this notice. FDA estimates, in the following tables, the total annual reporting and third party burden to collect and provide the required information to be 584,477 hours. In the Federal Register of November 17, 2017 (82 FR 54359), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment that did not suggest any changes to the information collection or burden estimates. The following is a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the reporting requirements of FDA's recall regulations. Recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA's regulated products, this summary reflects numbers across FDA. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Firm initiated recall (Sec. 2,853 1 2,853 25 71,325 7.46) and recall communications (Sec. 7.49).. Recall status reports (Sec. 2,853 13 37,089 10 370,890 7.53)......................... Termination of a recall (Sec. 2,853 1 2,853 10 28,530 7.55(b))...................... General industry guidance (Sec. 2,853 1 2,853 15 42,795 7.59)....................... -------------------------------------------------------------------------------- Total...................... .............. ............... .............. .............. 513,540 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. A. Firm Initiated Recall and Recall Communications We request firms that voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and tobacco to immediately notify the appropriate FDA District Office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms' recall strategy, and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. The estimates in table 1 are multiplied across the FDA product centers to arrive at a reporting burden estimate of 71,325 for firm initiated recall and recall communications. B. Recall Status Reports We request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This request only applies to firms with active recalls, and periodic status reports are estimated to be reported every 2 to 4 weeks. The estimates in table 1 are multiplied across the FDA product centers to arrive at a reporting burden estimate of 370,890 hours for recall status reports. C. Termination of a Recall We provide the firms an opportunity to request in writing that FDA end the recall. The Agency estimates it will receive 2,853 responses annually based on the average number of terminations over the past 3 fiscal years. The estimates in table 1 are multiplied across the FDA product centers to arrive at a reporting burden estimate of 28,530 for termination of a recall. D. Enforcement Policy We request that firms prepare and maintain a current written contingency plan for use in initiating and effecting a recall in accordance with Sec. Sec. 7.40 through 7.49, 7.53, and 7.55; use sufficient coding of regulated products to make possible positive lot identification and to facilitate effective recall of all violative lots and maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention. The estimates in table 1 are multiplied across the FDA product centers to arrive at a reporting burden estimate of 42,795 for enforcement policy. E. Recall Communications We request that firms notify their consignees of the recall and to provide recipients with a ready means of reporting to the recalling firm. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Recall communications (Sec. 2,853 518 1,477,854 0.048 (2.88 70,937 7.49). minutes). ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this information collections. [[Page 8286]] The estimates in table 2 are multiplied across the FDA product centers to arrive at a total third party disclosure burden estimate of 70,937. FDA regulates many different types of products including, but not limited to, medical products, food and feed, cosmetics, and tobacco products. FDA notes that not all third-party disclosures provided by firms to their consignees are similar in nature and may entail different methods and mediums of communication. The total burden hours have decreased since the last information collection approval based on a reduction in the number of respondents. Dated: February 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03847 Filed 2-23-18; 8:45 am] BILLING CODE 4164-01-P
![8284 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices
and/or go to the Dockets Management proposed participants, and an Office of Management and Budget
Staff, 5630 Fishers Lane, Rm. 1061, indication of the approximate time (OMB) for review and clearance under
Rockville, MD 20852. requested to make their presentation on the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: or before March 5, 2018. Time allotted DATES: Fax written comments on the
Kalyani Bhatt, Center for Drug for each presentation may be limited. If collection of information by March 28,
Evaluation and Research, Food and the number of registrants requesting to 2018.
Drug Administration, 10903 New speak is greater than can be reasonably ADDRESSES: To ensure that comments on
Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled the information collection are received,
Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may OMB recommends that written
796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the comments be faxed to the Office of
PDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public Information and Regulatory Affairs,
Committee Information Line, 1–800– hearing session. The contact person will OMB, Attn: FDA Desk Officer, Fax: 202–
741–8138 (301–443–0572 in the notify interested persons regarding their 395–7285, or emailed to oira_
Washington, DC area). A notice in the request to speak by March 6, 2018. submission@omb.eop.gov. All
Federal Register about last minute Persons attending FDA’s advisory comments should be identified with the
modifications that impact a previously committee meetings are advised that OMB control number 0910–0249. Also
announced advisory committee meeting FDA is not responsible for providing include the FDA docket number found
cannot always be published quickly access to electrical outlets. in brackets in the heading of this
enough to provide timely notice. For press inquiries, please contact the document.
Therefore, you should always check the Office of Media Affairs at fdaoma@
FOR FURTHER INFORMATION CONTACT:
FDA’s website at https://www.fda.gov/ fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the Jonna Capezzuto, Office of Operations,
AdvisoryCommittees/default.htm and Food and Drug Administration, Three
scroll down to the appropriate advisory public at its advisory committee
meetings and will make every effort to White Flint North, 10A–12M, 11601
committee meeting link, or call the Landsdown St., North Bethesda, MD
advisory committee information line to accommodate persons with disabilities.
If you require accommodations due to a 20852, 301–796–3794, PRAStaff@
learn about possible modifications fda.hhs.gov.
before coming to the meeting. disability, please contact Kalyani Bhatt
(see FOR FURTHER INFORMATION CONTACT) SUPPLEMENTARY INFORMATION: In
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss at least 7 days in advance of the compliance with 44 U.S.C. 3507, FDA
new drug application (NDA) 209229, meeting. has submitted the following proposed
lofexidine hydrochloride, submitted by FDA is committed to the orderly collection of information to OMB for
US WorldMeds, LLC, for mitigation of conduct of its advisory committee review and clearance.
symptoms associated with opioid meetings. Please visit our website at FDA Recall Regulations—21 CFR Part 7
withdrawal and facilitation of https://www.fda.gov/
completion of opioid discontinuation AdvisoryCommittees/About OMB Control Number 0910–0249—
treatment. AdvisoryCommittees/ucm111462.htm Extension
FDA intends to make background for procedures on public conduct during Section 701 of the Federal Food, Drug,
material available to the public no later advisory committee meetings. and Cosmetic Act charges the Secretary
than 2 business days before the meeting. Notice of this meeting is given under of Health and Human Services, through
If FDA is unable to post the background the Federal Advisory Committee Act (5 FDA, with the responsibility of assuring
material on its website prior to the U.S.C. app. 2). recalls (21 U.S.C. 371, Regulations and
meeting, the background material will Dated: February 20, 2018. Hearings, and 21 CFR part 7,
be made publicly available at the Leslie Kux, Enforcement Policy, Subpart C, Recalls
location of the advisory committee Associate Commissioner for Policy. (Including Product Corrections)—
meeting, and the background material [FR Doc. 2018–03808 Filed 2–23–18; 8:45 am] Guidance on Policy, Procedures, and
will be posted on FDA’s website after Industry Responsibilities which pertain
BILLING CODE 4164–01–P
the meeting. Background material is to the recall regulations and provide
available at https://www.fda.gov/ guidance to manufacturers on recall
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND responsibilities). The regulations and
default.htm. Scroll down to the HUMAN SERVICES guidance apply to all FDA-regulated
appropriate advisory committee meeting products (i.e., food, including animal
link. Food and Drug Administration feed; drugs, including animal drugs;
Procedure: Interested persons may medical devices, including in vitro
present data, information, or views, [Docket No. FDA–2017–N–6175] diagnostic products; cosmetics;
orally or in writing, on issues pending biological products intended for human
Agency Information Collection
before the committee. All electronic and use; and tobacco).
Activities; Submission for Office of
written submissions submitted to the These responsibilities of companies
Management and Budget Review;
docket (see ADDRESSES) on or before conducting recalls include providing
Comment Request; Food and Drug
March 13, 2018, will be provided to the FDA with complete details of the recall
Administration Recall Regulations
committee. Oral presentations from the including: (1) Reason(s) for the removal
public will be scheduled between AGENCY: Food and Drug Administration, or correction, risk evaluation, quantity
daltland on DSKBBV9HB2PROD with NOTICES
approximately 1 p.m. and 2 p.m. Those HHS. produced, distribution information,
individuals interested in making formal ACTION: Notice. firm’s recall strategy, a copy of any
oral presentations should notify the recall communication(s), and a contact
contact person and submit a brief SUMMARY: The Food and Drug official (§ 7.46); (2) notifying direct
statement of the general nature of the Administration (FDA) is announcing accounts of the recall, providing
evidence or arguments they wish to that a proposed collection of guidance regarding further distribution,
present, the names and addresses of information has been submitted to the giving instructions as to what to do with
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The estimates in table 2 are Landsdown St., North Bethesda, MD (§ 589.2001(c)(2)(ii)). Renderers that
multiplied across the FDA product 20852, 301–796–7726, PRAStaff@ receive, manufacture, process, blend, or
centers to arrive at a total third party fda.hhs.gov. distribute CMPAF, are required to
disclosure burden estimate of 70,937. SUPPLEMENTARY INFORMATION: In establish and maintain records
FDA regulates many different types of compliance with 44 U.S.C. 3507, FDA sufficient to track the CMPAF to ensure
products including, but not limited to, has submitted the following proposed that they are not introduced into animal
medical products, food and feed, collection of information to OMB for feed (§ 589.2001(c)(2)(vi)).
cosmetics, and tobacco products. FDA review and clearance. Renderers that receive, manufacture,
notes that not all third-party disclosures process, blend, or distribute any cattle
provided by firms to their consignees Substances Prohibited From Use in materials must establish and maintain
are similar in nature and may entail Animal Food or Feed—21 CFR records sufficient to demonstrate that
different methods and mediums of 589.2001 material rendered for use in animal feed
communication. The total burden hours OMB Control Number 0910–0627— was not manufactured from, processed
have decreased since the last Extension with, or does not otherwise contain,
information collection approval based CMPAF (§ 589.2001(c)(3)(i)).
on a reduction in the number of This information collection supports Renderers that receive, manufacture,
respondents. Agency regulations regarding substances process, blend, or distribute any cattle
prohibited from use in animal food or materials must, if these materials were
Dated: February 21, 2018. feed. Bovine spongiform obtained from an establishment that
Leslie Kux, encephalopathy (BSE) is a progressive segregates CMPAF from other materials,
Associate Commissioner for Policy. and fatal neurological disorder of cattle establish and maintain records to
[FR Doc. 2018–03847 Filed 2–23–18; 8:45 am] that results from an unconventional demonstrate that the supplier has
BILLING CODE 4164–01–P transmissible agent. BSE belongs to the adequate procedures in place to
family of diseases known as effectively exclude CMPAF from any
transmissible spongiform materials supplied (§ 589.2001(c)(3)(i)).
DEPARTMENT OF HEALTH AND encephalopathies (TSEs). All TSEs Records will meet this requirement if
HUMAN SERVICES affect the central nervous system of they include either: (1) Certification or
infected animals. Our regulation at other documentation from the supplier
Food and Drug Administration § 589.2001 (21 CFR 589.2001) entitled that materials supplied do not include
[Docket No. FDA–2011–N–0510] ‘‘Cattle materials prohibited in animal CMPAF (§ 589.2001(c)(3)(i)(A)) or (2)
food or feed to prevent the transmission documentation of another method
Agency Information Collection of bovine spongiform encephalopathy’’ acceptable to FDA, such as third-party
Activities; Submission for Office of is designed to further strengthen certification (§ 589.2001(c)(3)(i)(B)).
Management and Budget Review; existing safeguards against the Reporting: Under our regulations, we
Comment Request; Substances establishment and amplification of BSE may designate a country from which
Prohibited From Use in Animal Food or in the United States through animal cattle materials are not considered
Feed feed. The regulation prohibits the use of CMPAF. Section 589.2001(f) provides
certain cattle origin materials in the that a country seeking to be so
AGENCY: Food and Drug Administration, food or feed of all animals. These designated must send a written request
HHS. materials are referred to as ‘‘cattle to the Director of the Center for
ACTION: Notice. materials prohibited in animal feed’’ or Veterinary Medicine. The information
SUMMARY: The Food and Drug CMPAF. Under § 589.2001, no animal the country is required to submit
Administration (FDA) is announcing feed or feed ingredient can contain includes information about that
that a proposed collection of CMPAF. As a result, we impose country’s BSE case history, risk factors,
information has been submitted to the requirements on renderers of measures to prevent the introduction
Office of Management and Budget specifically defined cattle materials, and transmission of BSE, and any other
(OMB) for review and clearance under including reporting and recordkeeping information relevant to determining
the Paperwork Reduction Act of 1995. requirements. For purposes of the whether the cattle materials from the
regulation, we define a renderer as any requesting country do or do not meet
DATES: Fax written comments on the
firm or individual that processes the definitions set forth in
collection of information by March 28,
slaughter byproducts, animals unfit for § 589.2001(b)(1). We use the information
2018.
human consumption, including to determine whether to grant a request
ADDRESSES: To ensure that comments on
carcasses of dead cattle, or meat scraps. for designation and to impose
the information collection are received, Reporting and recordkeeping conditions if a request is granted.
OMB recommends that written requirements are necessary because Section 589.2001(f) further states that
comments be faxed to the Office of once materials are separated from an countries designated under that section
Information and Regulatory Affairs, animal it may not be possible, without will be subject to our future review to
OMB, Attn: FDA Desk Officer, Fax: 202– records, to know whether the cattle determine whether their designations
395–7285, or emailed to oira_ material meets the requirements of our remain appropriate. As part of this
submission@omb.eop.gov. All regulation. process, we may ask designated
comments should be identified with the Recordkeeping: Renderers that countries from time to time to confirm
OMB control number 0910–0627. Also receive, manufacture, process, blend, or that their BSE situation and the
daltland on DSKBBV9HB2PROD with NOTICES
include the FDA docket number found distribute CMPAF, or products that information submitted by them in
in brackets in the heading of this contain or may contain CMPAF, must support of their original application
document. take measures to ensure that the remains unchanged. We may revoke a
FOR FURTHER INFORMATION CONTACT: Ila materials are not introduced into animal country’s designation if we determine
S. Mizrachi, Office of Operations, Food feed, including maintaining adequate that it is no longer appropriate.
and Drug Administration, Three White written procedures specifying how such Therefore, designated countries may
Flint North, 10 a.m.–12 p.m., 11601 processes are to be carried out respond to our periodic requests by
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Document Created: 2018-02-24 01:00:49
Document Modified: 2018-02-24 01:00:49
| 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 28, 2018. | |
| Contact | Jonna Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 83 FR 8284 |
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