4098 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

TABLE 6—CLASS II DEVICES AND UNCLASSIFIED DEVICES PROPOSED EXEMPT FROM 510(k) REQUIREMENT—Continued 

Device 

description 

Device 

class 

Product 

code 

Section in 

21 CFR 

Oxygenator, Long Term Support Greater Than 6 Hours ................................................................................ II ............. FXY ........ 878.4040 

Transmitters And Receivers, Electrocardiograph, Telephone ........................................................................ II ............. ONT ....... 878.4040 

Extracorporeal System For Long-Term Respiratory/Cardiopulmonary Failure .............................................. II ............. OMC ...... 882.1400 

Implanted Subcutaneous Securement Catheter ............................................................................................. II ............. MOS ....... 892.1000 

Subcutaneous Implanted Apheresis Port ........................................................................................................ II ............. QHY ....... 892.1650 

C. Impact of Exemptions on Patient 

Access to Medical Devices 

With this Notice, the Department is 

immediately exempting 7 devices from 

the premarket notification requirement, 

and proposes to exempt an additional 

84 devices from the requirement after 

public comment is closed. As noted 

above in Part I.A, estimates on the cost 

of preparing a 510(k) submission range 

from $100,000 to $4 million. The 

exemptions provided for and proposed 

under this Notice for these 91 device 

classes could eliminate anywhere from 

$9.1 to $364 million in startup costs if 

there were one new entrant into each 

device market. Savings could further 

accrue based on each new market 

entrant. Instead of being costs passed 

along to patients and taxpayers, these 

savings could be invested in other areas 

such as research and development and 

manufacturing. 

At the same time, should these 

waivers go into effect as proposed, 

patients stand to gain more immediate 

access to new products that would 

otherwise be required to obtain a 510(k) 

clearance prior to marketing. 

The exemptions provided for in this 

Notice also conserve FDA’s scarce 

review resources. The COVID–19 PHE 

stretched FDA’s review capacity. Under 

this Notice, FDA’s review resources can 

be redeployed to review other 

innovative technology, to include 

devices designed to mitigate the impact 

of COVID–19. 

IV. Request for Information, Data, and 

Further Study 

HHS’ review in this Notice warrants 

expansion and further study. FDA’s 

medical device Product Code database 

contains 6,651 unique codes (to include 

those discussed in this Notice). Of those 

unique codes, 157 are for class I devices 

that require 510(k) clearance, and 2,662 

are for class II devices that require 

510(k) clearance. Applying the $100,000 

to $4 million in estimated costs for 

510(k) preparation and submission to 

these 2,819 devices yields 

approximately $281.9 million to 

$11.276 billion in startup costs, 

assuming one new market entrant in 

each of the 2,819 device classes. 

Further, again assuming a 90-day review 

period and one new device entrant in 

each of the 2,819 device classes that 

require 510(k) notification, FDA’s 

current approach creates 253,710 review 

days or 695.1 review years between 

Americans and new devices. The 

question of whether the 510(k) notice is 

justified in view of safety and efficacy 

concerns merits comprehensive analysis 

for the benefit of Americans. The 

Department seeks public comment, 

research, and analysis on whether other 

devices should be exempt from the 

premarket notification requirement. 

At a more detailed level, the 

Department observed internal 

inconsistencies in FDA’s regulation of 

some device classes that merit 

discussion. Manual stethoscopes are 

exempt from the premarket notification 

requirement. 21 CFR 870.1875(a)(2). 

Electronic stethoscopes are also exempt, 

but only if the device ‘‘is a lung sound 

monitor.’’ 21 CFR 870.1875(b)(2). 

Similarly, FDA exempts ‘‘clinical 

mercury thermometer . . . device[s] 

used to measure oral, rectal, or axillary 

(armpit) body temperature using the 

thermal expansion of mercury’’ from the 

510(k) premarket notification 

requirement. 21 CFR 880.2920. By 

contrast, clinical electronic 

thermometers which never enter into 

any body orifice require 510(k) 

premarket notification. 21 CFR 

880.2910. These apparent 

inconsistencies merit scientific scrutiny. 

To that end, the Department seeks 

public comment as to whether other 

inconsistencies in the medical device 

regulatory framework exist. 

Dated: January 8, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00787 Filed 1–14–21; 8:45 am] 

BILLING CODE 4150–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1657] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey of Drug 

Product Manufacturing, Processing, 

and Packing Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

16, 2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comment’’ or 

by using the search function. The title 

of this information collection is ‘‘Survey 

of Drug Product Manufacturing, 

Processing, and Packing Facilities.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

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. 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4099 

Survey of Drug Product Manufacturing, 

Processing, and Packing Facilities—21 

CFR parts 210 and 211 

OMB Control Number 0910–NEW 

FDA has the responsibility to regulate 

the safety, as well as the efficacy and 

quality, of drugs in the United States. 

Under the Food and Drug 

Administration Safety and Innovation 

Act, enacted in 2012, the term current 

good manufacturing practice (CGMP) 

includes the implementation of 

oversight and controls over the 

manufacturing, processing, and packing 

of drugs to ensure quality, including 

managing the risk of, and establishing 

the safety of, raw materials used in the 

manufacture of drugs. The safety and 

availability of drugs can be affected by 

raw material suppliers, the material 

supply chain, and the facility’s controls 

over raw material quality. Risk 

management enables manufacturers to 

make proper choices and ensure the 

continued suitability of these materials 

and supply chains. The Agency needs to 

better understand how manufacturers, 

processors, and packers of drug 

products approach managing risks 

related to components, containers, and 

closures as well as the supply and 

distribution chains between the 

producers of raw materials and drug 

product manufacturers, processors, and 

packers. Such information will allow 

FDA to examine the potential economic 

impact of changes to regulations that 

govern the manufacturing, processing, 

and packing of drugs. 

In the Federal Register of September 

18, 2020 (85 FR 58370), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

This is a one-time information 

collection, the primary purpose of 

which is to collect industry-wide data 

on how facilities that manufacture, 

process, and pack drug products for use 

in humans and/or animals ensure the 

quality of their operations, including 

their current risk management 

approaches and practices for ensuring 

the quality and suitability of the drug 

components, containers, and closures 

that they use. FDA intends to use this 

information to inform its economic 

analyses of potential updates to CGMPs 

for human and animal drug product 

manufacturing, processing, and packing 

facilities under 21 CFR parts 210 and 

211. Survey respondents will be 

contacted by email or, if necessary, by 

regular mail. Respondents will be able 

to take the survey online or, if 

requested, they can return a hard copy 

by mail. FDA estimates the maximum 

burden of this collection of information 

as follows: 

TABLE 1.—ESTIMATED BURDEN HOURS FOR ONE-TIME DATA COLLECTION1

Type of respondent/facility Number of respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

Group 1: Facilities in United States engaged in drug manufacturing (in addition to other possible activities).394 1 394 1.1 ............... 433 

Group 2: Facilities in United States not engaged in manufacturing but engaged in other forms of drug processing 

or packing (e.g., labeling, repacking, etc.).

333 1 333 0.75 .............

(45 minutes) 

250 

Group 3: Facilities outside United States engaged in drug 

manufacturing (in addition to other possible activities).

407 1 407 2.20 ............. 895 

Group 4: Facilities outside United States not engaged in 

manufacturing but engaged in other forms of drug processing or packing (e.g., labeling, repacking, etc.).

261 1 261 1.5 ............... 392 

Total ........................................................................................ 1,395 ........................ 1,395 ..................... 1,970 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Burden hours are based on pretests of 

the survey and interviews with industry 

representatives and reflect the time 

required by each type of respondent to 

read the survey invitation and 

instructions and complete the survey 

questions. The total estimated one-time 

burden hours are 1,970. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00838 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Faculty Loan 

Repayment Program; OMB No. 0915– 

0150—Revision 

AGENCY: Health Resources and Services 

Administration, (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 16, 

2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa