82 FR 26807 - Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 110 (June 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 110 (June 9, 2017)
| Page Range | 26807-26810 | |
| FR Document | 2017-12007 |
[Federal Register Volume 82, Number 110 (Friday, June 9, 2017)] [Notices] [Pages 26807-26810] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12007] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2901] Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s. DATES: These actions are effective on August 8, 2017. FOR FURTHER INFORMATION CONTACT: Constance Soves, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1437, Silver Spring, MD 20993-0002, 301- 796-6951. SUPPLEMENTARY INFORMATION: I. Background The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.), as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, based on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as post-amendments devices), are classified automatically by statute (section 513(f) of the FD&C Act) into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless FDA initiates one of the following procedures: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the FD&C Act; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i), to a predicate device that is already legally marketed. The Agency determines whether new devices are substantially equivalent to predicate devices through review of premarket notifications under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and its implementing regulations, codified in Title 21 of the Code of Federal Regulations (21 CFR part 807, subpart E), require persons who intend to market a new device that does not require a premarket approval application under section 515 of the FD&C Act (21 U.S.C. 360e) to submit a premarket notification report (510(k)) containing information that allows FDA to determine whether the new device is ``substantially equivalent'' within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. On December 13, 2016, the President signed into law the 21st Century Cures Act (Pub. L. 114-255) (Ref. 1). Section 3059 of the 21st Century Cures Act, in part, amends section 510 of the FD&C Act to require FDA to publish in the Federal Register a notice identifying a list of reusable device types that must include validated instructions for use and validation data regarding cleaning, disinfection, and sterilization in their 510(k) submissions. This section also [[Page 26808]] provides that a 510(k) submission for a reusable device may not be substantially equivalent to a predicate device if the validated instructions for use and reprocessing validation data submitted as part of the 510(k) are inadequate. Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use under 21 CFR 801.5 and 801.109. However, in recent years, there have been significant changes in knowledge and technology involved in reprocessing reusable medical devices. Additionally, there has been an evolution towards more complex reusable medical device designs that are more difficult to clean, disinfect, and sterilize. FDA believes reusable devices must be designed for adequate reprocessing and safe reuse, with comprehensive and clear instructions for effective reprocessing procedures for use by health care facilities that reprocess these devices. II. Requirements for Validated Reprocessing Instructions and Reprocessing Validation Data for Reusable Medical Devices A reusable medical device is one intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing steps between uses. FDA has issued recommendations for reprocessing reusable devices in relevant documents, including the FDA guidance ``Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,'' as information on the reprocessing validation methods necessary to be reported in a 510(k) submission (Ref. 2). FDA expects specific required validation data regarding cleaning, disinfection, and sterilization to be included in 510(k) submissions for certain reusable medical device types as outlined in tables 1 and 2 below. FDA believes that a majority of manufacturers for the reusable devices listed below are already conducting validation of their reprocessing instructions because FDA already has provided recommendations for reprocessing validation in relevant FDA documents. Sponsors of new 510(k) notifications for reusable devices identified in the tables below must also include validation data regarding cleaning, disinfection, and sterilization, in addition to all the other required elements of a 510(k) identified in 21 CFR 807.87, starting on August 8, 2017. III. List of Certain Reusable Medical Devices and Design Features The 21st Century Cures Act (section 3059) requires the Agency to identify and publish a list of reusable device types that are required to include ``instructions for use'' and ``validation data'' regarding cleaning, disinfection, and sterilization in 510(k) notifications. Accordingly, FDA is publishing the list in table 1 that identifies those reusable medical devices that FDA has determined pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. FDA believes arthroscopes, laparoscopic instruments, and electrosurgical instruments, and their respective accessories with specific design features, identified in table 2, may pose a challenge to adequate reprocessing. 510(k) notifications for such devices that incorporate any of the design features listed in table 2 must include validated reprocessing instructions and reprocessing validation data reports, and if such are determined to be inadequate, FDA will find the device not substantially equivalent. Table 1--Reusable Devices That Require Validation Data and Validated Reprocessing Instructions Be Included in 510(k) Notification and Upon Which FDA Will Determine Substantial Equivalence ---------------------------------------------------------------------------------------------------------------- Device type Product code Device name 21 CFR section ---------------------------------------------------------------------------------------------------------------- Bronchoscopes (flexible or rigid) EOQ Bronchoscope (flexible 21 CFR 874.4680 and accessories. PSV or rigid). 21 CFR 892.1550 Ultrasound bronchoscope. KTI Bronchoscope accessory 21 CFR 874.4680 BTG Brush, biopsy, 21 CFR 874.4680 bronchoscope (non- rigid). JEI Claw, foreign body, 21 CFR 874.4680 bronchoscope (non- rigid). JEL Curette, biopsy, 21 CFR 874.4680 bronchoscope (rigid). BST Curette, biopsy, 21 CFR 874.4680 bronchoscope (non- rigid). BWH Forceps, biopsy, 21 CFR 874.4680 bronchoscope (non- rigid). JEK Forceps, biopsy, 21 CFR 874.4680 bronchoscope (rigid). ENZ Telescope, laryngeal- 21 CFR 874.4680 bronchial. KTR Tube, aspirating, 21 CFR 874.4680 bronchoscope (rigid). JEJ Tubing, 21 CFR 874.4680 Instrumentation, bronchoscope (brush sheath A/O aspirating). Ear, Nose, and Throat (ENT) EOX Esophagoscope 21 CFR 874.4710 endoscopes and accessories. GCL (flexible or rigid). 21 CFR 876.1500 Esophagoscope, general & plastic surgery. FDW Esophagoscope, rigid, 21 CFR 876.1500 gastro-urology. EOB Nasopharyngoscope 21 CFR 874.4760 (flexible or rigid). EQN Laryngoscope, 21 CFR 874.4760 nasopharyngoscope. EWY Mediastinoscope, 21 CFR 874.4720 surgical, and accessories. Gastroenterology and Urology FDT Duodenoscope and 21 CFR 876.1500 Endoscopes that have elevator FAK accessories, flexible/ 21 CFR 876.1500 channels (not including ODF rigid. 21 CFR 876.1500 accessories). Panendoscope [e.g., duodenoscopes used for (gastroduodenoscope). endoscopic retrograde Mini endoscope, cholangiopancreatography (ERCP)]. gastroenterology- urology. Automated Reprocessors for Reusable FEB Accessories, cleaning, 21 CFR 876.1500 Devices. NZA for endoscopes. 21 CFR 876.1500 Accessories, germicide, cleaning, for endoscopes. OUJ High level 21 CFR 892.1570 disinfection reprocessing instrument for ultrasonic transducers, mist. NVE Washer, cleaner, 21 CFR 876.1500 automated, endoscope. PSW High level 21 CFR 892.1570 disinfection reprocessing instrument for ultrasonic transducers, liquid. [[Page 26809]] Other Flexible Gastroenterology and FDF Colonoscope and 21 CFR 876.1500 Urology Endoscopes \1\ (not FBN accessories, flexible/ 21 CFR 876.1500 including accessories). rigid. Choledochoscope and accessories, flexible/ rigid. FDA Enteroscope and 21 CFR 876.1500 accessories. FDS Gastroscope and 21 CFR 876.1500 accessories, flexible/ rigid. FAJ Cystoscope and 21 CFR 876.1500 accessories, flexible/ rigid. FGB Ureteroscope and 21 CFR 876.1500 accessories, flexible/ rigid. ODG Endoscopic ultrasound 21 CFR 876.1500 system, gastroenterology- urology. Neurological endoscopes (not GWG Endoscope, 21 CFR 882.1480 including accessories). neurological. Water-based heater-cooler systems DWC Controller, 21 CFR 870.4250 for use in operating rooms. DWJ Temperature, 21 CFR 870.5900 Cardiopulmonary Bypass. System, Thermal Regulating. System, Surgical, Computer NAY System, Surgical, 21 CFR 876.1500 Controlled Instrument. Computer Controlled Instrument. Arthroscopes and accessories \2\.... HRX Arthroscope........... 21 CFR 888.1100 Laparoscopic instruments and GCJ Laparoscope, general 21 CFR 876.1500 accessories \2\. and plastic surgery. Electrosurgical instruments and GEI Electrosurgical, 21 CFR 878.4400 accessories \2\. cutting and coagulation and accessories. ---------------------------------------------------------------------------------------------------------------- \1\ For endoscopes that fall under these product codes, 510(k) submissions must include reprocessing validation data for those endoscopes which are flexible. \2\ For devices that fall under these product codes, 510(k) submissions must include reprocessing validation data if the device possesses any of the design features listed in table 2 below. Table 2--Design Features Which May Pose a Challenge to Adequate Reprocessing for Arthroscopes, Laparoscopic Instruments, and Electrosurgical Instruments, and Their Respective Accessories ------------------------------------------------------------------------ ------------------------------------------------------------------------- Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, lumens with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too small to permit a brush to pass through). Hinges, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise ``roughened'' surfaces (e.g., jaws). Interior device channels. Sleeves surrounding rods, blades, activators, inserters, etc. Shafts within lumens. Adjacent device surfaces between which debris can be forced or caught during use. O-rings. Stopcocks/Valves. Crevices. Fittings with very close tolerances. Clamps that cannot be fully opened for cleaning. Small internal parts (e.g., springs, magnets, etc.) that may become soiled. Ridges, articulations or grooves. Rough, irregular, discontinuous surfaces that can entrap or retain soil. Capillary gaps. Luer locks. Porous materials (smooth surfaces are desirable, where possible). Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments). Dead-ended chambers. Internal movable device components such as multiple cables. Device features that may entrap debris that can later become aerosolized (e.g., through application of power, etc.). Devices with these or other design features that cannot be disassembled for reprocessing. ------------------------------------------------------------------------ The Agency believes that these devices currently have the greatest risk of infection transmission and inadequate performance if not adequately reprocessed. In the future, the Agency may reevaluate and revise both tables as it deems necessary. IV. Paperwork Reduction Act of 1995 This notice refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 801 have been approved under OMB control number 0910-0485 (medical device labeling); the collections of information in part 807, subpart E have been approved under OMB control number 0910-0120 (premarket notification); and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073 (quality system regulation). V. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. 21st Century Cures Act, Public Law 114-255, available at https://www.congress.gov/114/bills/hr34/BILLS-114hr34eah.pdf. 2. FDA's Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 2015, available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf. [[Page 26810]] Dated: June 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12007 Filed 6-8-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 110 / Friday, June 9, 2017 / Notices 26807
Location Grantee Amount
New York, NY ........................................... Cayuga Home for Children DBA Cayuga Centers ...................................................... 5,404,388
New York, NY ........................................... Cayuga Home for Children DBA Cayuga Centers ...................................................... 1,052,501
New York, NY ........................................... Catholic Guardian Services ......................................................................................... 1,664,514
Yonkers, NY .............................................. Leake and Watts Services, Inc .................................................................................... 1,804,974
Yonkers, NY .............................................. Leake and Watts Services, Inc .................................................................................... 473,826
U.S. Multi-City ........................................... Southwest Keys, Inc .................................................................................................... 10,257,820
U.S. Multi-City ........................................... Southwest Keys, Inc .................................................................................................... 1,330,080
ORR is continuously monitoring its DEPARTMENT OF HEALTH AND regulatory controls needed to provide
capacity to provide post-release services HUMAN SERVICES reasonable assurance of their safety and
to the unaccompanied alien children in effectiveness. The three categories of
HHS custody. ORR has specific Food and Drug Administration devices are class I (general controls),
requirements for the provision of [Docket No. FDA–2017–N–2901] class II (special controls), and class III
services. Award recipients must have (premarket approval).
the infrastructure, licensing, experience, Medical Devices; Validated Devices introduced into interstate
and appropriate level of trained staff to Instructions for Use and Validation commerce for the first time on or after
Data Requirements for Certain May 28, 1976 (generally referred to as
meet those requirements. The expansion
Reusable Medical Devices in post-amendments devices), are
of the existing post-release services
Premarket Notifications classified automatically by statute
program through this supplemental (section 513(f) of the FD&C Act) into
award is a key strategy for ORR to be AGENCY: Food and Drug Administration, class III without any FDA rulemaking
prepared to meet its responsibility of HHS. process. These devices remain in class
safe and timely release of ACTION: Notice. III and require premarket approval,
Unaccompanied Alien Children referred unless FDA initiates one of the
to its care by DHS and so that the US SUMMARY: The Food and Drug following procedures: (1) FDA
Border Patrol can continue its vital Administration (FDA or Agency) has reclassifies the device into class I or II;
national security mission to prevent determined that it is necessary for (2) FDA issues an order classifying the
illegal migration, trafficking, and protect manufacturers of certain reusable device into class I or II in accordance
the borders of the United States. medical devices to include in their with section 513(f)(2) of the FD&C Act;
premarket notifications (510(k)s) or (3) FDA issues an order finding the
Statutory Authority: This program is instructions for use which have been
authorized by— device to be substantially equivalent,
validated and validation data regarding under section 513(i), to a predicate
(A) Section 462 of the Homeland cleaning, disinfection, and sterilization, device that is already legally marketed.
Security Act of 2002, which in March for which a substantial equivalence The Agency determines whether new
2003, transferred responsibility for the determination may be based. This notice devices are substantially equivalent to
care and custody of Unaccompanied includes a list of these reusable devices predicate devices through review of
Alien Children from the Commissioner that will require validated instructions premarket notifications under section
of the former Immigration and for use and validation data in their 510(k) of the FD&C Act (21 U.S.C.
Naturalization Service (INS) to the premarket notification. FDA is 360(k)). Section 510(k) of the FD&C Act
Director of ORR of the Department of publishing this list in accordance with and its implementing regulations,
Health and Human Services (HHS). the requirements established by the 21st codified in Title 21 of the Code of
Century Cures Act. This action ensures Federal Regulations (21 CFR part 807,
(B) The Flores Settlement Agreement, that the premarket requirements for subpart E), require persons who intend
Case No. CV85–4544RJK (C.D. Cal. these device types are clear and to market a new device that does not
1996), as well as the William predictable which facilitates more require a premarket approval
Wilberforce Trafficking Victims efficient review of these 510(k)s. application under section 515 of the
Protection Reauthorization Act of 2008 DATES: These actions are effective on FD&C Act (21 U.S.C. 360e) to submit a
(Pub. L. 110–457), which authorizes August 8, 2017. premarket notification report (510(k))
post release services under certain FOR FURTHER INFORMATION CONTACT: containing information that allows FDA
conditions to eligible children. All Constance Soves, Food and Drug to determine whether the new device is
programs must comply with the Flores Administration, Center for Devices and ‘‘substantially equivalent’’ within the
Settlement Agreement, Case No. CV85– Radiological Health, 10903 New meaning of section 513(i) of the FD&C
4544–RJK (C.D. Cal. 1996), pertinent Hampshire Ave., Bldg. 66, Rm. 1437, Act to a legally marketed device that
regulations and ORR policies and Silver Spring, MD 20993–0002, 301– does not require premarket approval.
procedures. 796–6951. On December 13, 2016, the President
SUPPLEMENTARY INFORMATION: signed into law the 21st Century Cures
Elizabeth Leo,
Act (Pub. L. 114–255) (Ref. 1). Section
Grants Policy Specialist, Division of Grants I. Background 3059 of the 21st Century Cures Act, in
Policy, Office of Administration, The Federal Food, Drug, and Cosmetic part, amends section 510 of the FD&C
mstockstill on DSK30JT082PROD with NOTICES
Administration for Children and Families. Act (the FD&C Act) (21 U.S.C. 301 et Act to require FDA to publish in the
[FR Doc. 2017–11940 Filed 6–8–17; 8:45 am] seq.), as amended, established a Federal Register a notice identifying a
BILLING CODE 4184–45–P comprehensive system for the regulation list of reusable device types that must
of medical devices intended for human include validated instructions for use
use. Section 513 of the FD&C Act (21 and validation data regarding cleaning,
U.S.C. 360c) establishes three categories disinfection, and sterilization in their
(classes) of devices, based on the 510(k) submissions. This section also
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![26808 Federal Register / Vol. 82, No. 110 / Friday, June 9, 2017 / Notices
provides that a 510(k) submission for a same or different patients, with III. List of Certain Reusable Medical
reusable device may not be substantially appropriate cleaning and other Devices and Design Features
equivalent to a predicate device if the reprocessing steps between uses. FDA
validated instructions for use and has issued recommendations for The 21st Century Cures Act (section
reprocessing validation data submitted reprocessing reusable devices in 3059) requires the Agency to identify
as part of the 510(k) are inadequate. relevant documents, including the FDA and publish a list of reusable device
Manufacturers of reusable medical guidance ‘‘Reprocessing Medical types that are required to include
devices are responsible for having Devices in Health Care Settings: ‘‘instructions for use’’ and ‘‘validation
labeling that bears adequate directions Validation Methods and Labeling,’’ as data’’ regarding cleaning, disinfection,
for use, including instructions on information on the reprocessing and sterilization in 510(k) notifications.
preparing a device for use under 21 CFR validation methods necessary to be Accordingly, FDA is publishing the list
801.5 and 801.109. However, in recent reported in a 510(k) submission (Ref. 2). in table 1 that identifies those reusable
years, there have been significant FDA expects specific required medical devices that FDA has
changes in knowledge and technology validation data regarding cleaning, determined pose a greater likelihood of
involved in reprocessing reusable disinfection, and sterilization to be microbial transmission and represent a
medical devices. Additionally, there has included in 510(k) submissions for high risk of infection (subclinical or
been an evolution towards more certain reusable medical device types as clinical) if they are not adequately
complex reusable medical device outlined in tables 1 and 2 below. reprocessed.
designs that are more difficult to clean, FDA believes that a majority of
manufacturers for the reusable devices FDA believes arthroscopes,
disinfect, and sterilize. FDA believes
reusable devices must be designed for listed below are already conducting laparoscopic instruments, and
adequate reprocessing and safe reuse, validation of their reprocessing electrosurgical instruments, and their
with comprehensive and clear instructions because FDA already has respective accessories with specific
instructions for effective reprocessing provided recommendations for design features, identified in table 2,
procedures for use by health care reprocessing validation in relevant FDA may pose a challenge to adequate
facilities that reprocess these devices. documents. Sponsors of new 510(k) reprocessing. 510(k) notifications for
notifications for reusable devices such devices that incorporate any of the
II. Requirements for Validated identified in the tables below must also design features listed in table 2 must
Reprocessing Instructions and include validation data regarding include validated reprocessing
Reprocessing Validation Data for cleaning, disinfection, and sterilization, instructions and reprocessing validation
Reusable Medical Devices in addition to all the other required data reports, and if such are determined
A reusable medical device is one elements of a 510(k) identified in 21 to be inadequate, FDA will find the
intended for repeated use either on the CFR 807.87, starting on August 8, 2017. device not substantially equivalent.
TABLE 1—REUSABLE DEVICES THAT REQUIRE VALIDATION DATA AND VALIDATED REPROCESSING INSTRUCTIONS BE
INCLUDED IN 510(k) NOTIFICATION AND UPON WHICH FDA WILL DETERMINE SUBSTANTIAL EQUIVALENCE
Product
Device type Device name 21 CFR section
code
Bronchoscopes (flexible or rigid) and accessories .... EOQ Bronchoscope (flexible or rigid) ......................................... 21 CFR 874.4680
PSV Ultrasound bronchoscope .................................................. 21 CFR 892.1550
KTI Bronchoscope accessory ................................................... 21 CFR 874.4680
BTG Brush, biopsy, bronchoscope (non-rigid) ........................... 21 CFR 874.4680
JEI Claw, foreign body, bronchoscope (non-rigid) ................... 21 CFR 874.4680
JEL Curette, biopsy, bronchoscope (rigid) ................................ 21 CFR 874.4680
BST Curette, biopsy, bronchoscope (non-rigid) ......................... 21 CFR 874.4680
BWH Forceps, biopsy, bronchoscope (non-rigid) ........................ 21 CFR 874.4680
JEK Forceps, biopsy, bronchoscope (rigid) ............................... 21 CFR 874.4680
ENZ Telescope, laryngeal-bronchial .......................................... 21 CFR 874.4680
KTR Tube, aspirating, bronchoscope (rigid) .............................. 21 CFR 874.4680
JEJ Tubing, Instrumentation, bronchoscope (brush sheath A/ 21 CFR 874.4680
O aspirating).
Ear, Nose, and Throat (ENT) endoscopes and ac- EOX Esophagoscope (flexible or rigid) ....................................... 21 CFR 874.4710
cessories. GCL Esophagoscope, general & plastic surgery ....................... 21 CFR 876.1500
FDW Esophagoscope, rigid, gastro-urology ................................ 21 CFR 876.1500
EOB Nasopharyngoscope (flexible or rigid) ............................... 21 CFR 874.4760
EQN Laryngoscope, nasopharyngoscope .................................. 21 CFR 874.4760
EWY Mediastinoscope, surgical, and accessories ...................... 21 CFR 874.4720
Gastroenterology and Urology Endoscopes that FDT Duodenoscope and accessories, flexible/rigid ................... 21 CFR 876.1500
have elevator channels (not including acces- FAK Panendoscope (gastroduodenoscope) .............................. 21 CFR 876.1500
sories). ODF Mini endoscope, gastroenterology-urology ........................ 21 CFR 876.1500
[e.g., duodenoscopes used for endoscopic retro-
mstockstill on DSK30JT082PROD with NOTICES
grade cholangiopancreatography (ERCP)].
Automated Reprocessors for Reusable Devices ...... FEB Accessories, cleaning, for endoscopes .............................. 21 CFR 876.1500
NZA Accessories, germicide, cleaning, for endoscopes ............ 21 CFR 876.1500
OUJ High level disinfection reprocessing instrument for ultra- 21 CFR 892.1570
sonic transducers, mist.
NVE Washer, cleaner, automated, endoscope .......................... 21 CFR 876.1500
PSW High level disinfection reprocessing instrument for ultra- 21 CFR 892.1570
sonic transducers, liquid.
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Dated: June 5, 2017. Block Grant to States Program: enhanced definition of ‘‘evidence-base’’
Anna K. Abram, Guidance and Forms for the Title V provided. Clarifying instructions and
Deputy Commissioner for Policy, Planning, Application/Annual Report. This state examples of ESMs have been
Legislation, and Analysis. guidance is used annually by the 50 added.
[FR Doc. 2017–12007 Filed 6–8–17; 8:45 am] states and 9 jurisdictions (hereafter (5) Expectations around state Title V
BILLING CODE 4164–01–P state) in applying for Block Grants reporting on family/consumer
under Title V of the Social Security Act partnership have been clarified. These
and in preparing the required annual expectations include enhanced
DEPARTMENT OF HEALTH AND report. The updates proposed by discussion of specific program
HUMAN SERVICES HRSA’s Maternal and Child Health activities, the impact they have on all
Bureau (MCHB) for this edition of the sectors of the MCH population, and
Health Resources and Services guidance are intended to reinforce the their demonstrated value in improving
Administration role of the state in developing a Title V MCH outcomes.
Maternal and Child Health (MCH) (6) The narrative reporting
Agency Information Collection Action Plan that addresses its priority requirements around services for
Activities: Proposed Collection: Public needs. These proposed updates further CSHCN have been strengthened to allow
Comment Request; Information refine the reporting structure and vision each state to identify and define the
Collection Request Title: Title V that was outlined in the previous components of its system of services.
Maternal and Child Health Services edition. As such, they are intended to States are also encouraged to reflect on
Block Grant to States Program: enable a state to articulate its Title V the impact of these services within the
Guidance and Forms for the Title V program activities and leadership efforts context of the identified priority needs
Application/Annual Report OMB No. for serving the MCH population. The and the measures selected for the State
0915–0172—Revision proposed updates to the guidance are Action Plan.
informed by comments received from (7) Further anticipated reductions to
AGENCY: Health Resources and Services state burden have been incorporated
Administration (HRSA), Department of state Title V MCH program leaders,
national MCH leaders, and other MCH through more streamlined narrative
Health and Human Services. reporting, particularly between the State
stakeholders.
ACTION: Notice. Overview, Needs Assessment, and State
Specific updates to this edition of the
SUMMARY: In compliance with the Title V Maternal and Child Health Action Plan sections; clearer
requirement for opportunity for public Services Block Grant to States Program: descriptions of expected content in each
comment on proposed data collection Guidance and Forms for the Title V of the narrative sections; and refined
projects, HRSA announces plans to Application/Annual Report include the instructions for completing the data
submit an Information Collection following: reporting forms. Notable among these
Request (ICR), described below, to the (1) The performance measure updates is the restructuring of the State
Office of Management and Budget framework has been maintained, but a Action Plan narrative discussion to
(OMB). Prior to submitting the ICR to state has added flexibility to determine allow a Title V program greater
OMB, HRSA seeks comments from the the best combination of National flexibility in describing its public health
public regarding the burden estimate, Performance Measures (NPMs) and State framework (e.g., life course model),
below, or any other aspect of the ICR. Performance Measures (SPMs) for leadership and partnership roles, cross-
addressing its identified MCH priority cutting strategies, and the leveraging of
DATES: Comments on this ICR must be
needs. States will address each priority resources.
received no later than August 8, 2017. need by either a NPM or SPM. The full extent of the anticipated
ADDRESSES: Submit your comments to (2) The required minimum number of burden reduction will be realized over
paperwork@hrsa.gov or mail the HRSA NPMs to be selected by a state has been time as states become more familiar
Information Collection Clearance reduced from eight to five. States will with the updated instructions and
Officer, Room 14N39, 5600 Fishers select at least one NPM in each of the reporting requirements. The burden
Lane, Rockville, MD 20857. five population health domains, estimates presented in the table below
FOR FURTHER INFORMATION CONTACT: To specifically: (1) Women/Maternal are based on previous burden estimates
request more information on the Health; (2) Perinatal/Infant Health; (3) and consultation with a few states.
proposed project or to obtain a copy of Child Health; (4) Children with Special Need and Proposed Use of the
the data collection plans and draft Health Care Needs (CSHCN); and (5) Information: Each year, states are
instruments, email paperwork@hrsa.gov Adolescent Health. required to submit an application/
or call the HRSA Information Collection (3) A sixth and optional domain, annual report for Federal funds for their
Clearance Officer at (301) 443–1984. Cross-cutting and Systems Building, has Title V MCH Services Block Grant to
SUPPLEMENTARY INFORMATION: When been added to replace the Cross-cutting/ States Program to HRSA’s MCHB
submitting comments or requesting Life Course domain. The three NPMs (Section 505(a) of Title V of the Social
information, please include the that were formerly included in the Security Act). In addition, each state is
information request collection title for Cross-cutting/Life Course domain (i.e., required to conduct a comprehensive
reference, in compliance with Section NPM #13A/B, NPM #14 A/B and NPM needs assessment every 5 years. The
3506(c)(2)(A) of the Paperwork #15) have been incorporated into the information and instructions for the
Reduction Act of 1995. relevant population health domain(s). preparation and submission of this
Information Collection Request Title: No NPMs are included in the Cross- application/annual report are contained
mstockstill on DSK30JT082PROD with NOTICES
Title V Maternal and Child Health cutting and Systems Building domain; in the Title V Maternal and Child
Services Block Grant to States Program: however, a state may choose to include Health Services Block Grant to States
Guidance and Forms for the Title V a SPM in this domain if relevant to its Program: Guidance and Forms for the
Application/Annual Report, OMB No. priority needs. Title V Application/Annual Report.
0915–0172—Revision (4) The focus on evidence-based or Likely Respondents: Per section 505(a)
Abstract: HRSA is updating the Title evidence-informed strategies and of Title V of the Social Security Act, the
V Maternal and Child Health Services measures (ESMs) continues, with an MCH Block Grant application/annual
VerDate Sep<11>2014 19:25 Jun 08, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\09JNN1.SGM 09JNN1](https://thefederalregister.org/doc/82_FR_26917/page/4.svg)
Document Created: 2017-06-09 01:11:44
Document Modified: 2017-06-09 01:11:44
| 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 | These actions are effective on August 8, 2017. | |
| Contact | Constance Soves, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1437, Silver Spring, MD 20993-0002, 301- 796-6951. | |
| FR Citation | 82 FR 26807 |
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