81 FR 40312 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 119 (June 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 119 (June 21, 2016)
| Page Range | 40312-40315 | |
| FR Document | 2016-14584 |
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)] [Notices] [Pages 40312-40315] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14584] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0297] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions 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 July 21, 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 0910-0660. 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Prevention of Salmonella Enteritidis in Shell Eggs During Production-- Recordkeeping and Registration Provisions--21 CFR 118.10 and 118.11; OMB Control Number 0910-0660--Extension Shell eggs contaminated with Salmonella Enteritidis (SE) are responsible for more than 140,000 illnesses per year. The Public Health Service Act (PHS Act) authorizes the Secretary to make and enforce such regulations as ``are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States . . . or from one State . . . into any other State'' (section 361(a) of the PHS Act). This authority has been delegated to the Commissioner of Food and Drugs. Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4)), a food is adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. Under part 118 (21 CFR part 118), shell egg producers are required to implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation. Shell egg producers also [[Page 40313]] are required to maintain records concerning their compliance with part 118 and to register with FDA. As described in more detail with regard to each information collection provision of part 118, each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, must refrigerate, register, and keep certain records. Farms that do not send all of their eggs to treatment are also required to have an SE prevention plan and to test for SE. Section 118.10 of FDA's regulations requires recordkeeping for all measures the farm takes to prevent SE in its flocks. Since many existing farms participate in voluntary egg quality assurance programs, those respondents may not have to collect any additional information. Records are maintained on file at each farm site and examined there periodically by FDA inspectors. Section 118.10 also requires each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, and does not have all of the shell eggs treated, to design and implement an SE prevention plan. Section 118.10 requires recordkeeping for each of the provisions included in the plan and for plan review and modifications if corrective actions are taken. Finally, Sec. 118.11 of FDA's regulations requires that each farm covered by Sec. 118.1(a) register with FDA using Form FDA 3733. The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at http://www.access.fda.gov. We strongly encourage electronic registration because it is faster and more convenient. The system can accept electronic registrations 24 hours a day, 7 days a week. A registering shell egg producer receives confirmation of electronic registration instantaneously once all the required fields on the registration screen are completed. However, paper registrations will also be accepted. Form FDA 3733 is available for download for registration by mail or CD-ROM. Recordkeeping and registration are necessary for the success of the SE prevention measures. Written SE prevention plans and records of actions taken due to each provision are essential for farms to implement SE prevention plans effectively. Further, they are essential for us to be able to determine compliance. Information provided under these regulations helps us to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply. In addition, data collected through registration is used to support our enforcement activities. Description of Respondents: Respondents to this information collection include farm sites with 3,000 or more egg laying hens that sell raw eggs to the table egg market, other than directly to the consumer. In the Federal Register of January 28, 2016 (81 FR 4923), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two comments in response, both of which supported the collection of information by FDA to ensure that farms are in compliance with the FD&C Act and regulations, and that adequate control measures for prevention of SE are being implemented. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of Description and 21 CFR section recordkeepers records per Total annual Average burden per recordkeeping Total hours \2\ recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Refrigeration Records, Sec. 118.10(a)(3)(iv) 2,600 52 135,200 .5 (30 minutes) 67,600 Testing, Diversion, and Treatment Records, 343 52 17,836 .5 (30 minutes) 8,918 Sec. 118.10(a)(3)(v) through (viii) (positive) \3\. Egg Testing, Sec. 118.10(a)(3)(vii)......... 331 7 2,317 8.3 19,231 Environmental Testing, Sec. 118.10(a)(3)(v) 6,308 23 145,084 .25 (15 minutes) 36,271 \3\. Testing, Diversion, and Treatment Records, 5,965 1 5,965 .5 (30 minutes) 2,983 Sec. 118.10(a)(3)(v) through (viii) (negative) \3\. Prevention Plan Review and Modifications, Sec. 331 1 331 10 3,310 118.10(a)(4). Chick and Pullet Procurement Records, Sec. 4,731 1 4,731 .5 (30 minutes) 2,366 118.10(a)(2). Rodent and Other Pest Control, Sec. 9,462 52 492,024 .5 (30 minutes) 246,012 118.10(a)(3)(ii), and Biosecurity Records, Sec. 118.10(a)(3)(i). Prevention Plan Design, Sec. 118.10(a)(1)... 300 1 300 20 6,000 Cleaning and Disinfection Records, Sec. 331 1 331 .5 (30 minutes) 166 118.10(a)(3)(iii). --------------------------------------------------------------------------------------------------------- Total hours............................... 392,857 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Some records are kept on a by-farm basis and others are kept on a by-house basis. \3\ Calculations include requirements for pullet and layer houses. We are basing our estimates for the recordkeeping burden and the reporting burden on our experience with similar recordkeeping activities and the number of registrations and cancellations received in the past 3 years. The number of recordkeepers estimated in column 2 of table 1 is drawn from estimates of the total number of layer and pullet houses affected by part 118. We assume that those farms that are operating according to recognized industry or State quality assurance plans are already largely in compliance with the plan design and recordkeeping provisions discussed in this section, and therefore are not experiencing additional costs to comply with recordkeeping provisions. We found that 59 percent of farms with more than 50,000 layers are members of State or industry quality assurance plans. Fewer than 8 percent of farms with fewer than 50,000 layers are members of quality assurance plans. Thus, we estimate the number of layer farms incurring a new recordkeeping [[Page 40314]] burden because of part 118 to be 2,600, and the number of houses affected to be 4,731. Prevention plan design (Sec. 118.10(a)(1)) records are kept on a per farm basis, so we assume that new prevention plan design is only undertaken by new entrants to the industry. Refrigeration records (Sec. 118.10(a)(3)(iv)) are also kept on a per farm basis so the estimated number of recordkeepers for this provision is 2,600. Records of chick and pullet procurement (Sec. 118.10(a)(2)), rodent and other pest control (Sec. 118.10(a)(3)(ii)), and biosecurity (Sec. 118.10(a)(3)(i)) are kept on a per house basis, so the estimated number of recordkeepers for these provisions is 4,731. Records of cleaning and disinfection (Sec. 118.10(a)(3)(iii)) are also kept on a per house basis, but only need to be kept in the event that a layer house tests environmentally positive for SE. Prevention plan review and modifications (Sec. 118.10(a)(4)) also need to be performed every time a house tests positive, which we estimate that 7 percent tests positive. Therefore, the number of recordkeepers for these provisions is calculated to be 331 (4,731 houses x 0.070) annually. Records of testing, diversion, and treatment (Sec. 118.10(a)(3)(v) through (viii)) are kept on a per house basis and include records on flocks from pullet houses. We estimate that there are one-third as many pullet houses as there are layer houses. Therefore the total number of recordkeepers for these provisions is 6,308 (4,731 + (4,731/3)). The number of annual records kept depends on whether or not houses test positive for SE. Annually, 343 layer and pullet houses ((4,731 layer houses x 0.070) + (4731/3 pullet houses) x 0.0075)) are expected to test positive and 5,965 are expected to test negative ((4,731 layer houses x 0.930) + (4731/3 pullet houses) x 0.9925)). We assume that refrigeration records are kept on a weekly basis on a per farm basis under Sec. 118.10(a)(3)(iv)). We estimate that 2,600 recordkeepers maintain 52 records each for a total of 135,200 records and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for refrigeration records is calculated to be 67,600 hours (135,200 x 0.5 hour). We assume that records of testing, diversion, and treatment under Sec. 118.10(a)(3)(v) through (viii) are kept weekly in the event a layer house tests environmentally positive for SE. We estimate that 343 layer and pullet houses test positive and thus 343 recordkeepers maintain 52 records each for a total of 17,836 records and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for testing, diversion, and treatment records in the event of a positive test result is calculated to be 8,918 hours (17,836 x 0.5 hour). Given a positive environmental test for SE, we estimate the weighted average number of egg tests per house under Sec. 118.10(a)(3)(vii)) to be 7. We estimate that 331 recordkeepers maintain 7 records each for a total of 2,317 records and that it takes approximately 8.3 hours per recordkeeping. Thus, the total annual burden for egg testing is calculated to be 19,231 hours (2,317 x 8.3 hours). We estimate that all 1,577 pullet and 4,731 layer houses not currently testing (6,308 recordkeepers) incur the burden of a single environmental test annually under Sec. 118.10(a)(3)(v)). The number of samples taken during the test depends on whether a farm employs the row based method (an average of 12 samples per house) or the random sampling method (32 samples per house). We estimate that roughly 50 percent of the houses affected employ a row based method and 50 percent employs a random sampling method, implying an average of 23 samples per house. Thus, we estimate that 6,308 recordkeepers take 23 samples each for a total of 145,084 samples. The time burden of sampling is estimated on a per swab sample basis. We estimate that it takes approximately 15 minutes to collect and pack each sample. Thus, the total annual burden for environmental testing is calculated to be 36,271 hours (145,084 x 0.25 hour). We estimate that records of testing, diversion, and treatment under Sec. 118.10(a)(3)(v) through (viii) are kept annually in the event a layer house tests environmentally negative for SE. We estimate that 5,965 layer and pullet houses test negative and thus 5,965 recordkeepers maintain 1 record of that testing that takes approximately 0.5 hour per record. Thus, the total annual burden for testing, diversion, and treatment records in the event of a negative test result is calculated to be 2,983 hours (5,965 x 0.5 hour). Prevention plan review and modifications under Sec. 118.10(a)(4)) need to be performed every time a house tests positive. We estimate that 331 layer houses test positive requiring plan review and modifications and that it takes 10 hours to complete this work. Thus, the total annual burden for prevention plan review and modifications in the event of a positive test result is calculated to be 3,310 hours (331 x 10 hours). We estimate that chick and pullet procurement records under Sec. 118.10(a)(2) is kept roughly once annually per layer house basis. We estimate that 4,731 layer houses maintain 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for chick and pullet procurement recordkeeping is calculated to be 2,366 hours (4,731 x 0.5 hour). We estimate that rodent and other pest control records under Sec. 118.10(a)(3)(ii)) and biosecurity records under Sec. 118.10(a)(3)(i) are kept weekly on a per layer house basis. We assume that 4,731 layer houses maintain a weekly record under each provision. Thus, we estimate 9,462 recordkeepers maintain 52 records each for a total of 492,024 records. We estimate a recordkeeping burden of 0.5 hours per record for a total of 246,012 burden hours (492,024 x 0.5 hour). New prevention plan design required by Sec. 118.10(a)(1) is only undertaken by new farms and records are kept on a per farm basis. We estimate that there are 300 new farm registrations annually and we assume that this reflects 300 new farms requiring prevention plan design. This is an increase from our previous estimate based on new registrations received. We estimate that it takes 20 hours to complete this work. Thus, the total annual burden for prevention plan design is calculated to be 6,000 hours (300 x 20 hours). Cleaning and disinfection recordkeeping under Sec. 118.10(a)(3)(iii) needs to be performed every time a house tests positive. We estimate that 331 layer houses test positive requiring 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for cleaning and disinfection recordkeeping in the event of a positive test result is calculated to be 166 hours (331 x 0.5 hour). [[Page 40315]] Table 2--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Description and 21 CFR section FDA form No. Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Registrations or Updates, Sec. 118.11... Form FDA 3733 \2\........... 300 1 300 2.3 690 Cancellations, Sec. 118.11.............. Form FDA 3733............... 30 1 30 1 30 ------------------------------------------------------------------------------------------------------------- Total................................. ............................ .............. .............. .............. .............. 720 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at http://www.access.fda.gov per Sec. 118.11(b)(1). This estimate is based on the average number of new shell egg producer registrations and cancellations received in the past 3 years under Sec. 118.11. We estimate that we will receive an average of 300 registrations or updates per year over the next 3 years. Based on the number of cancellations previously received, we estimate that we will receive approximately 30 cancellations per year over the next 3 years. We estimate that it takes the average farm 2.3 hours to register, taking into account that some respondents completing the registration may not have readily available Internet access. Thus, the total annual burden for new shell egg producer registrations or updates is calculated to be 690 hours (300 x 2.3 hours). We estimate cancelling a registration, on average, requires a burden of approximately 1 hour, taking into account that some respondents may not have readily available Internet access. Thus, the total annual burden for cancelling shell egg producer registrations is calculated to be 30 hours (30 cancellations x 1 hour). Dated: June 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14584 Filed 6-20-16; 8:45 am] BILLING CODE 4164-01-P
![40312 Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
respondents, including through the use Holocaust survivors living in the U.S., (OMB) for review and clearance under
of automated collection techniques and other isolated groups of older the Paperwork Reduction Act of 1995.
when appropriate, and other forms of adults. To that end, comments are DATES: Fax written comments on the
information technology. specifically requested on the extent to collection of information by July 21,
To be eligible to receive a formula which the direction provided is 2016.
grant under Section 307 (a) of the Older sufficient for states to fully assess the
Americans Act (OAA) of 1965, as existence of, and develop plans for ADDRESSES: To ensure that comments on
amended, each State Unit on Aging serving, these individuals and their the information collection are received,
(SUA) is required to develop a State families. If commenters believe the OMB recommends that written
Plan on Aging that conforms to proposed direction is insufficient, this comments be faxed to the Office of
requirements and priorities outlined by solicitation requests comments Information and Regulatory Affairs,
the Assistant Secretary for Aging. Such containing the specific guidance desired OMB, Attn: FDA Desk Officer, FAX:
plans are required, by statute, to be as well as the practical means and data 202–395–7285, or emailed to oira_
completed by each state and territory available to implement said guidance, submission@omb.eop.gov. All
every two, three or four years. States direction and requirements for states. comments should be identified with the
with current two- or three-year plans When completed annually by ACL/ OMB control number 0910–0660. Also
may request an extension, or may AoA staff, the template presented here include the FDA docket number found
amend their current plans if needed; for comment will yield a Program in brackets in the heading of this
however, at the end of a four-year plan, Instruction containing the necessary document.
states must develop a new plan. There information states need to develop and FOR FURTHER INFORMATION CONTACT: FDA
is no statutory authority to extend a submit their state plans on aging. ACL/ PRA Staff, Office of Operations, Food
plan beyond a four-year period. AoA estimates the burden of this data and Drug Administration, 8455
State plans must address key collection as follows: approximately one Colesville Rd., COLE–14526, Silver
objectives and focus areas as articulated third (1⁄3) of the 56 State Units on Aging Spring, MD 20993–0002, PRAStaff@
by the Assistant Secretary for Aging. (or approximately 18 states per year) fda.hhs.gov.
Objectives and focus areas may change submit a new state plan in a given year.
periodically in accordance with the SUPPLEMENTARY INFORMATION: In
Estimates as to the amount of time it compliance with 44 U.S.C. 3507, FDA
evolution of policies and practices takes to prepare and submit a state plan
pertaining to the provision of home and has submitted the following proposed
vary greatly. Recent feedback from states collection of information to OMB for
community-based supportive services to indicates that, on average, it takes a state
older adults and their family caregivers. review and clearance.
approximately 750 hours to prepare and
Additionally, state plans must include submit a state plan on aging. The Prevention of Salmonella Enteritidis
specific assurances that the state will in Shell Eggs During Production—
proposed Program Instruction template
carry out certain activities in accordance Recordkeeping and Registration
may be found on the ACL Web site for
with the OAA. Finally, states are Provisions—21 CFR 118.10 and 118.11;
review at: http://www.aoa.acl.gov/AoA_
required to develop (or revise) and OMB Control Number 0910–0660—
Programs/OAA/Aging_Network/pi/PI-
submit an Intrastate Funding Formula Extension
Template.aspx.
(IFF), detailing how Federal funds made
available under the OAA will be Dated: June 14, 2016. Shell eggs contaminated with
disbursed throughout the state. The Kathy Greenlee, Salmonella Enteritidis (SE) are
information submitted to ACL/AoA via Administrator and Assistant Secretary for responsible for more than 140,000
the state plan is used for Federal Aging. illnesses per year. The Public Health
oversight of Title III and VII programs, [FR Doc. 2016–14612 Filed 6–20–16; 8:45 am] Service Act (PHS Act) authorizes the
ensuring that OAA funds are serving as BILLING CODE 4154–01–P
Secretary to make and enforce such
a base for a broader system of long-term regulations as ‘‘are necessary to prevent
services and supports for older adults in the introduction, transmission, or
the state and that funds are being DEPARTMENT OF HEALTH AND spread of communicable diseases from
targeted in accordance with the HUMAN SERVICES foreign countries into the States . . . or
requirements of the Act. from one State . . . into any other
With respect to targeting, LGBT Food and Drug Administration State’’ (section 361(a) of the PHS Act).
advocates are urging ACL to require This authority has been delegated to the
[Docket No. FDA–2013–N–0297] Commissioner of Food and Drugs.
states, in their state plans, to provide
assurances that they will assess all Under section 402(a)(4) of the Federal
Agency Information Collection
groups that may be eligible for Food, Drug, and Cosmetic Act (the
Activities; Submission for Office of
designation as a ‘‘greatest social need’’ FD&C Act) (21 U.S.C. 342(a)(4)), a food
Management and Budget Review;
population and expressly include LGBT is adulterated if it is prepared, packed,
Comment Request; Prevention of
older adults as one of those groups or held under insanitary conditions
Salmonella Enteritidis in Shell Eggs
whose needs must be assessed by the whereby it may have been contaminated
During Production; Recordkeeping and
State Unit on Aging. Additionally, the with filth or rendered injurious to
Registration Provisions
recently reauthorized OAA directs the health. Under section 701(a) of the
Assistant Secretary for Aging to issue Food and Drug Administration, FD&C Act (21 U.S.C. 371(a)), FDA is
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY:
guidance for conducting outreach to, HHS. authorized to issue regulations for the
and serving, Holocaust survivors. In this ACTION: Notice. efficient enforcement of the FD&C Act.
regard, ACL wants to know whether the Under part 118 (21 CFR part 118),
targeting guidance as articulated on SUMMARY: The Food and Drug shell egg producers are required to
pages 5–6 of the template is feasible and Administration (FDA) is announcing implement measures to prevent SE from
likely to ensure maximum inclusion of that a proposed collection of contaminating eggs on the farm and
all populations of seniors, including information has been submitted to the from further growth during storage and
older American Indians, LGBT seniors, Office of Management and Budget transportation. Shell egg producers also
VerDate Sep<11>2014 18:37 Jun 20, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1](https://thefederalregister.org/doc/81_FR_40431/page/1.svg)
![Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices 40315
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Description and 21 CFR section FDA form No. responses per burden per Total hours
respondents responses
respondent response
Registrations or Updates, § 118.11 ... Form FDA 3733 2 300 1 300 2.3 690
Cancellations, § 118.11 ...................... Form FDA 3733 ... 30 1 30 1 30
Total ............................................ .............................. ........................ ........................ ........................ ........................ 720
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 3733’’ refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Reg-
istration Module, which is available at http://www.access.fda.gov per § 118.11(b)(1).
This estimate is based on the average information has been submitted to the FDA to make a classification
number of new shell egg producer Office of Management and Budget determination for the accessory device
registrations and cancellations received (OMB) for review and clearance under according to the criteria in section
in the past 3 years under § 118.11. We the Paperwork Reduction Act of 1995 513(a)(1) of the FD&C Act. The de novo
estimate that we will receive an average (the PRA). must include a description of the device
of 300 registrations or updates per year DATES: Fax written comments on the and detailed information and reasons
over the next 3 years. Based on the collection of information by July 21, for any recommended classification (see
number of cancellations previously 2016. section 513(f)(2)(A)(v) of the FD&C Act).
received, we estimate that we will In the Federal Register of January 20,
ADDRESSES: To ensure that comments on
receive approximately 30 cancellations 2015 (80 FR 2710), FDA published a 60-
the information collection are received,
per year over the next 3 years. day notice requesting public comment
OMB recommends that written
We estimate that it takes the average on the proposed collection of
comments be faxed to the Office of
farm 2.3 hours to register, taking into information. We received a total of 12
Information and Regulatory Affairs,
account that some respondents comments on the guidance. Of these the
OMB, Attn: FDA Desk Officer, FAX:
completing the registration may not following were related to the
202–395–7285, or emailed to oira_
have readily available Internet access. information collection:
submission@omb.eop.gov. All
Thus, the total annual burden for new
comments should be identified with the Two comments raised concerns
shell egg producer registrations or
OMB control number 0910–NEW and regarding the possible difficulties for
updates is calculated to be 690 hours
title ‘‘Medical Device Accessories.’’ Also manufacturers to submit a de novo for
(300 × 2.3 hours).
We estimate cancelling a registration, include the FDA docket number found new accessories and for risk- and
in brackets in the heading of this regulatory control-based classification of
on average, requires a burden of
document. accessories that were approved under
approximately 1 hour, taking into
account that some respondents may not FOR FURTHER INFORMATION CONTACT: FDA the premarket approval application
have readily available Internet access. PRA Staff, Office of Operations, Food (PMA) for the parent medical devices.
Thus, the total annual burden for and Drug Administration, 8455 One comment questioned whether FDA
cancelling shell egg producer Colesville Rd., COLE–14526, Silver considered the possible ‘‘practical and
registrations is calculated to be 30 hours Spring, MD 20993–0002, PRAStaff@ economic impact’’ of the proposed
(30 cancellations × 1 hour). fda.hhs.gov. definition of ‘‘accessories’’ that may
result in manufacturers being obligated
Dated: June 15, 2016. SUPPLEMENTARY INFORMATION: In
to list some components as accessories
Leslie Kux, compliance with 44 U.S.C. 3507, FDA for FDA’s registration and listing
Associate Commissioner for Policy. has submitted the following proposed
process. The second comment
collection of information to OMB for
[FR Doc. 2016–14584 Filed 6–20–16; 8:45 am] anticipates that ‘‘few companies are
review and clearance.
BILLING CODE 4164–01–P likely to pursue this route given the
Medical Device Accessories—OMB associated costs and minimal advantage
Control Number 0910–NEW in time to market.’’ Neither comment
DEPARTMENT OF HEALTH AND The draft guidance encourages specifically discusses the potential PRA
HUMAN SERVICES manufacturers and other parties to burden hours of voluntarily submitting
utilize the process defined in section a de novo application; however, it may
Food and Drug Administration be inferred that this could impact their
513(f)(2) of the Federal Food, Drug, and
[Docket No. FDA–2016–N–1593] Cosmetic Act (the FD&C Act) to request resources under the PRA for submitting
risk- and regulatory control-based a de novo.
Agency Information Collection classifications of new types of Also, FDA is not proposing to limit or
Activities; Submission for Office of accessories. This process provides a remove any mechanism that currently
Management and Budget Review; pathway to class I or class II exists for manufacturers to obtain
Comment Request; Medical Device classification for accessory devices for marketing authorization for accessories.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Accessories which general controls, or general and De novos are typically less burdensome
AGENCY: Food and Drug Administration, special controls, provide a reasonable than PMAs for the purpose of
HHS. assurance of safety and effectiveness, classifying a new accessory.
ACTION: Notice. but for which there is no legally Furthermore, if a manufacturer wishes
marketed predicate device. for an accessory to remain in the same
SUMMARY: The Food and Drug In accordance with section 513(f)(2) of regulatory class as the parent device,
Administration (FDA) is announcing the FD&C Act, manufacturers and other that manufacturer may continue to
that a proposed collection of parties may submit a de novo requesting submit the accessory for clearance or
VerDate Sep<11>2014 18:37 Jun 20, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1](https://thefederalregister.org/doc/81_FR_40431/page/4.svg)
Document Created: 2016-06-21 01:30:09
Document Modified: 2016-06-21 01:30:09
| 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 July 21, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 40312 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR