81 FR 51204 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 149 (August 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 149 (August 3, 2016)
| Page Range | 51204-51205 | |
| FR Document | 2016-18299 |
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)] [Notices] [Pages 51204-51205] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18299] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0375] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization 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 September 2, 2016. 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 0910-0131. 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 10A-12M, 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. Agreement for Shipment of Devices for Sterilization--21 CFR 801.150-- OMB Control Number 0910-0131--Extension Under sections 501(c) and 502(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are adulterated and misbranded. FDA regulations in Sec. 801.150(e) (21 CFR 801.150(e)) establish a control mechanism by which firms may manufacture and label medical devices as sterile at one establishment and ship the devices in interstate commerce for sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Under Sec. 801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following: (1) Instructions for maintaining accountability of the number of units in each shipment, (2) acknowledgment that the devices that are nonsterile are being shipped for further processing, and (3) specifications for sterilization processing. This agreement allows the manufacturer to ship misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. During routine plant inspections, FDA normally reviews agreements that must be kept for 2 years after final shipment or delivery of devices (Sec. 801.150(a)(2)). The respondents to this collection of information are device manufacturers and contract sterilizers. FDA's estimate of the reporting burden is based on data obtained from industry over the past several years. It is estimated that each of the firms subject to this requirement prepares an average of 20 written agreements each year. This estimate varies greatly, from 1 to 100, because some firms provide sterilization services on a part-time basis for only one customer, while others are large facilities with many customers. The average time required to prepare each written agreement is estimated to be 4 hours. This estimate varies depending on whether the agreement is the initial agreement or an annual renewal, on the format each firm elects to use, and on the length of time required to reach agreement. The estimate applies only to those portions of the written agreement that pertain to the requirements [[Page 51205]] imposed by this regulation. The written agreement generally also includes contractual agreements that are a usual and customary business practice. The recordkeeping requirements of Sec. 801.150(a)(2) consist of making copies and maintaining the records required under the third- party disclosure section of this collection. In the Federal Register of April 20, 2016 (81 FR 23309), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden ---------------------------------------------------------------------------------------------------------------- Average burden Number of Number of Total annual per 21 CFR section recordkeepers records per records recordkeeping Total hours recordkeeper (hours) ---------------------------------------------------------------------------------------------------------------- Record retention, 801.150(a)(2). 90 20 1,800 .5 900 ---------------------------------------------------------------------------------------------------------------- Table 2--Estimated Annual Third-Party Disclosure Burden ---------------------------------------------------------------------------------------------------------------- Number of Average burden Activity/21 CFR section Number of disclosures Total annual per disclosure Total hours respondents per respondent disclosures (hours) ---------------------------------------------------------------------------------------------------------------- Agreement and labeling 90 20 1,800 4 7,200 requirements, 801.150(e)....... ---------------------------------------------------------------------------------------------------------------- Dated: July 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18299 Filed 8-2-16; 8:45 am] BILLING CODE 4164-01-P
![51204 Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1,2,3—Continued
Number of Average
Activity/21 CFR Number of Total annual
FDA form responses per burden per Total hours
section respondents responses
respondent response
Annual reports— 3628—General .................................. 1,466 1 1,466 18 26,388
1002.13(a)–(b). 3634—TV ...........................................
3638—Diagnostic x-ray .....................
3641—Cabinet x-ray ..........................
3643—Microwave oven .....................
3636—Laser ......................................
3631—Sunlamp .................................
3647—Mercury vapor lamp ...............
3645—Ultrasonic therapy ..................
1 This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not
include all ICs approved under OMB control number 0910–0025. The draft guidance, if finalized, would be a reduction to the burden estimate for
these ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to
avoid confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the
draft guidance.
2 There are no capital costs or operating and maintenance costs associated with this collection of information.
3 Totals may not sum due to rounding.
The draft guidance also refers to (OMB) for review and clearance under sterilization at another establishment, a
previously approved collections of the Paperwork Reduction Act of 1995. practice that facilitates the processing of
information found in FDA regulations. DATES: Fax written comments on the devices and is economically necessary
These collections of information are collection of information by September for some firms.
subject to review by OMB under the 2, 2016. Under § 801.150(e)(1), manufacturers
PRA. The collections of information in ADDRESSES: To ensure that comments on
and sterilizers may sign an agreement
21 CFR part 807, subpart E have been the information collection are received, containing the following: (1)
approved under OMB control number OMB recommends that written Instructions for maintaining
0910–0120; the collections of accountability of the number of units in
comments be faxed to the Office of
information in 21 CFR part 801 have each shipment, (2) acknowledgment that
Information and Regulatory Affairs,
been approved under OMB control the devices that are nonsterile are being
OMB, Attn: FDA Desk Officer, FAX:
number 0910–0485; the collections of shipped for further processing, and (3)
202–395–7285, or emailed to oira_
information in 21 CFR part 820 have specifications for sterilization
submission@omb.eop.gov. All
been approved under OMB control processing. This agreement allows the
comments should be identified with the
number 0910–0073. The collections of manufacturer to ship misbranded
OMB control number 0910–0131. Also
information in 21 CFR parts 1002 products to be sterilized without
include the FDA docket number found
through 1050 are approved under OMB initiating regulatory action and provides
in brackets in the heading of this
control number 0910–0025. FDA with a means to protect consumers
document. from use of nonsterile products. During
Dated: July 28, 2016. FOR FURTHER INFORMATION CONTACT: FDA routine plant inspections, FDA normally
Leslie Kux, PRA Staff, Office of Operations, Food reviews agreements that must be kept
Associate Commissioner for Policy. and Drug Administration, Three White for 2 years after final shipment or
[FR Doc. 2016–18300 Filed 8–2–16; 8:45 am] Flint North 10A–12M, 11601 delivery of devices (§ 801.150(a)(2)).
BILLING CODE 4164–01–P Landsdown St., North Bethesda, MD The respondents to this collection of
20852, PRAStaff@fda.hhs.gov. information are device manufacturers
SUPPLEMENTARY INFORMATION: In and contract sterilizers. FDA’s estimate
DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA of the reporting burden is based on data
HUMAN SERVICES has submitted the following proposed obtained from industry over the past
collection of information to OMB for several years. It is estimated that each of
Food and Drug Administration the firms subject to this requirement
review and clearance.
prepares an average of 20 written
[Docket No. FDA–2013–N–0375] Agreement for Shipment of Devices for agreements each year. This estimate
Sterilization—21 CFR 801.150—OMB varies greatly, from 1 to 100, because
Agency Information Collection Control Number 0910–0131—Extension some firms provide sterilization services
Activities; Submission for Office of
Under sections 501(c) and 502(a) of on a part-time basis for only one
Management and Budget Review;
the Federal Food, Drug, and Cosmetic customer, while others are large
Comment Request; Agreement for
Act (the FD&C Act) (21 U.S.C. 351(c) facilities with many customers. The
Shipment of Devices for Sterilization
and 352(a)), nonsterile devices that are average time required to prepare each
Food and Drug Administration, labeled as sterile but are in interstate written agreement is estimated to be 4
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY:
HHS. transit to a facility to be sterilized are hours. This estimate varies depending
ACTION: Notice. adulterated and misbranded. FDA on whether the agreement is the initial
regulations in § 801.150(e) (21 CFR agreement or an annual renewal, on the
SUMMARY: The Food and Drug 801.150(e)) establish a control format each firm elects to use, and on
Administration (FDA) is announcing mechanism by which firms may the length of time required to reach
that a proposed collection of manufacture and label medical devices agreement. The estimate applies only to
information has been submitted to the as sterile at one establishment and ship those portions of the written agreement
Office of Management and Budget the devices in interstate commerce for that pertain to the requirements
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![Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices 51205
imposed by this regulation. The written and maintaining the records required comment on the proposed collection of
agreement generally also includes under the third-party disclosure section information. No comments were
contractual agreements that are a usual of this collection. received.
and customary business practice. The In the Federal Register of April 20, FDA estimates the burden of this
recordkeeping requirements of 2016 (81 FR 23309), FDA published a collection of information as follows:
§ 801.150(a)(2) consist of making copies 60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Average
Number of
Number of Total annual burden per
21 CFR section records per Total hours
recordkeepers records recordkeeping
recordkeeper (hours)
Record retention, 801.150(a)(2) .......................................... 90 20 1,800 .5 900
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of Average
Number of disclosures Total annual burden per
Activity/21 CFR section Total hours
respondents per disclosures disclosure
respondent (hours)
Agreement and labeling requirements, 801.150(e) ............. 90 20 1,800 4 7,200
Dated: July 28, 2016. DEPARTMENT OF HEALTH AND and Transplantation Research; 93.856,
Leslie Kux, HUMAN SERVICES Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Associate Commissioner for Policy.
[FR Doc. 2016–18299 Filed 8–2–16; 8:45 am] National Institutes of Health Dated: July 28, 2016.
BILLING CODE 4164–01–P Melanie J. Gray,
National Institute of Allergy and
Program Analyst, Office of Federal Advisory
Infectious Diseases; Notice of Closed
Committee Policy.
Meeting
DEPARTMENT OF HEALTH AND [FR Doc. 2016–18391 Filed 8–2–16; 8:45 am]
HUMAN SERVICES Pursuant to section 10(d) of the BILLING CODE 4140–01–P
Federal Advisory Committee Act, as
Office of the Secretary amended (5 U.S.C. App.), notice is
hereby given of the following meeting. DEPARTMENT OF HEALTH AND
Delegation of Authorities The meeting will be closed to the HUMAN SERVICES
Notice is hereby given that I have public in accordance with the
provisions set forth in sections Substance Abuse and Mental Health
delegated to the Commissioner of Food
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Services Administration
and Drugs (the Commissioner) those
authorities vested in the Secretary of the as amended. The grant applications and [Docket No. SAMHSA–2016–0002]
Department of Health and Human the discussions could disclose
Services under sections 1002; 1003; confidential trade secrets or commercial Request for Comment on Report
1004; 1005(f); and 1006(b) and (d) of the property such as patentable material, Entitled: Advancing the Care of
Food and Drug Administration and personal information concerning Pregnant and Parenting Women With
Amendments Act of 2007 (Pub. L. 110– individuals associated with the grant Opioid Use Disorder and Their Infants:
85), which relate to the functions of the applications, the disclosure of which A Foundation for Clinical Guidance
Food and Drug Administration. would constitute a clearly unwarranted
invasion of personal privacy. AGENCY: Substance Abuse and Mental
This authority may be re-delegated. Health Services Administration
This delegation will be exercised in Name of Committee: National Institute of (SAMHSA), Department of Health and
accordance with the Department of Allergy and Infectious Diseases Special
Emphasis Panel; NIAID SBIR Phase II Human Services (HHS).
Health and Human Services’ applicable Clinical Trial Implementation (U44). ACTION: Request for comment.
policies, procedures, guidelines, and Date: August 30, 2016.
regulations. Time: 1:00 p.m. to 3:00 p.m. SUMMARY: SAMHSA, Center for
I ratify and affirm any actions taken Agenda: To review and evaluate grant Substance Abuse Treatment (CSAT), in
by the Commissioner or the applications. HHS announces the opening of a docket
Commissioner’s subordinates that Place: National Institutes of Health, 3F100, to obtain public comment on a report
5601 Fishers Lane, Rockville, MD 20892, entitled: Advancing the Care of Pregnant
involved the exercise of the authority (Telephone Conference Call). and Parenting Women with Opioid Use
asabaliauskas on DSK3SPTVN1PROD with NOTICES
delegated herein prior to the effective Contact Person: Lynn Rust, Ph.D.,
date of this delegation. This delegation Scientific Review Officer, Scientific Review Disorder and their Infants: A
was effective on November 17, 2015. Program, Division of Extramural Activities, Foundation for Clinical Guidance.
Room 3G42A, National Institutes of Health/ This report describes the formal
Dated: July 27, 2016. process agreed on and followed under
NIAID, 5601 Fishers Lane, MSC 9823,
Sylvia M. Burwell, Bethesda, MD 20892–9823, (240) 669–5069, the guidance of the federal steering
Secretary. lrust@niaid.nih.gov. committee (FSC). It explains the RAND
[FR Doc. 2016–18417 Filed 8–2–16; 8:45 am] (Catalogue of Federal Domestic Assistance Corporation (RAND)/University of
BILLING CODE P Program Nos. 93.855, Allergy, Immunology, California Los Angeles (UCLA)
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Document Created: 2016-08-02 23:44:04
Document Modified: 2016-08-02 23:44:04
| 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 September 2, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 51204 |
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