12484 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

forthcoming public advisory committee 

meeting of the Circulatory System 

Devices Panel of the Medical Devices 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. 

DATES: The meeting will take place 

virtually on April 6, 2021, from 9 a.m. 

Eastern Time to 6 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability may 

be accessed at: https://www.fda.gov/ 

advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, 

MD 20993–0002, aden.asefa@

fda.hhs.gov, 301–796–0400, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On April 6, 

2021, the committee will discuss, make 

recommendations, and vote on 

information regarding the premarket 

approval application for the 

TransMedics Organ Care System (OCS) 

Heart, by TransMedics, Inc. The 

proposed Indication for Use for the 

TransMedics OCS Heart, is as follows: 

The TransMedics Organ Care System 

(OCS) Heart System is a portable 

extracorporeal heart perfusion and 

monitoring system indicated for the 

resuscitation, preservation, and 

assessment of donor hearts in a nearphysiologic, normothermic, and beating 

state intended for a potential transplant 

recipient. 

OCS Heart is indicated for donor 

hearts with one or more of the following 

characteristics: 

• Expected cross-clamp or ischemic 

time ≥4 hours due to donor or 

recipient characteristics (e.g., 

donor- recipient geographical 

distance, expected recipient 

surgical time); or 

• Expected total cross-clamp time of 

≥2 hours PLUS one of the following risk 

factors: 

• Donor Age ≥55 years; or 

• Donors with history of cardiac 

arrest and downtime ≥20 minutes; or 

• Donor history of alcoholism; or 

• Donor history of diabetes; or 

• Donor Left Ventricular Ejection 

Fraction ≤50 percent but ≥40 percent; or 

• Donor history of Left Ventricular 

Hypertrophy (septal or posterior wall 

thickness of >12 and ≤16 mm); or 

• Donor angiogram with luminal 

irregularities but no significant coronary 

artery disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

advisory-committees/circulatory-systemdevices-panel/2021-meeting-materialscirculatory-system-devices-panel. Select 

the link for the 2021 Meeting Materials. 

The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 30, 2021. 

Oral presentations from the public will 

be scheduled on April 6, 2021, between 

approximately 1 p.m. Eastern Time and 

2 p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before March 22, 2021. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 23, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallet 

at Artair.Mallet@fda.hhs.gov or 301– 

796–9638 at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04371 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1411] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for Data To Support Cross-Center 

Collaboration for Social Behavioral 

Sciences Associated With Disease 

Prevention, Treatment, and the Safety, 

Efficacy, and Usage of Food and Drug 

Administration Regulated Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a proposed collection 


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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12485 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 2, 

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 Comments’’ or 

by using the search function. The title 

of this information collection is 

‘‘Generic Clearance for Data to Support 

Cross-Center Collaboration for Social 

Behavioral Sciences Associated with 

Disease Prevention, Treatment, and the 

Safety, Efficacy, and Usage of FDA 

Regulated Products.’’ 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. 

Generic Clearance for Data To Support 

Cross-Center Collaboration for Social 

Behavioral Sciences Associated With 

Disease Prevention, Treatment, and the 

Safety, Efficacy, and Usage of FDA 

Regulated Products 

OMB Control Number 0910–NEW 

FDA is seeking to conduct qualitative 

and quantitative research studies to 

better understand consumers’, patients’, 

caregivers’, academic/scientific experts’, 

and public health professionals’ 

perceptions and behaviors regarding 

various issues and outcomes associated 

with disease prevention, treatment, and 

the safety and efficacy of all FDAregulated products. These studies may 

consist of small groups, focus groups/ 

town halls, individual indepth 

interviews, and surveys relating to the 

evaluation of disease prevention and 

treatment and the safety, efficacy, and 

usage of FDA-regulated products; the 

studies may also include 

communication messages and strategies, 

and other materials directed to 

consumers, patients, caregivers, and 

public health professionals (e.g., 

evaluate the effectiveness of 

communication messages, educational 

materials, and interventions directed 

toward promoting and protecting 

human and animal health). 

Among the general provisions of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), FDA is charged with 

promoting the public health through 

regulatory oversight as well as clinical 

research. Specifically, section 

1003(d)(2)(C) and (D) of the FD&C Act 

(21 U.S.C. 393(d)(2)(C) and (D)) provides 

that the Commissioner of Food and 

Drugs shall be responsible for research. 

Accordingly, FDA is seeking to conduct 

qualitative and quantitative research 

studies. 

The information collection is 

intended to support research conducted 

by, or on behalf of, FDA. Understanding 

consumers’, patients’, caregivers’, 

academic/scientific experts’, and public 

health professionals’ perceptions and 

behaviors plays an important role in 

improving FDA’s decision-making 

processes and communications 

impacting various stakeholders. To 

better understand consumers’, patients’, 

caregivers’, academic/scientific experts’, 

and public health professionals’ 

perceptions and behaviors regarding 

various issues and outcomes associated 

with disease prevention, treatment, and 

the safety, efficacy, and usage of 

products overseen by the Agency, FDA 

is requesting approval of this generic 

information collection request. 

The qualitative and quantitative 

research anticipated by FDA aligns with 

Agency objectives. For example, among 

eight scientific priorities is the goal to 

support social and behavioral sciences. 

Such research helps the Agency meet 

this goal by: 

• Identifying gaps in the target 

audiences’ knowledge regarding FDAregulated products, and outcomes 

associated the disease prevention and 

treatment; 

• reaching diverse audiences; 

• assessing target audiences’ 

knowledge, perceptions, and behaviors 

about FDA-regulated products; 

• evaluating the effectiveness of 

FDA’s communications; 

• exploring ways to incorporate 

patient input into decision making; 

• leveraging real-world data; 

• evaluating outcomes; and 

• integrating the knowledge gained 

from the research into Agency 

communications, activities, 

interventions, and programs. 

FDA will only submit a collection for 

approval under this generic clearance if 

it meets the following condition: 

Information provided by respondents 

will be kept private and anonymous, 

except as otherwise required by law. 

This will be communicated to 

respondents by means of introductory 

letters, explanatory texts on the cover 

pages of questionnaires, scripts read 

prior to focus groups or telephone 

interviews, and consent forms as 

appropriate. Respondents also will be 

advised of the following: (1) The nature 

of the activity; (2) the intended purpose 

and use of the data collected; (3) FDA 

sponsorship (when appropriate); and (4) 

the fact that participation is voluntary at 

all times. Because responses are 

voluntary, respondents will be assured 

that there will be no penalties if they 

decide not to respond, either to the 

information collection as a whole or to 

any individual questions. 

Only Agency or Agency-sponsored 

personnel will have access to 

individual-level surveys, interviews, or 

focus group data. All project staff from 

a contractor or cooperative agreement 

grantee conducting the information 

collection must take required measures 

to ensure respondent privacy and 

confidentiality of data. Personally 

identifiable information (PII) shall be 

limited to data that may be required in 

the process of respondent enrollment. 

PII will be accessible to only those 

contractors or cooperative agreement 

grantees who need it and will not be 

linked to interview data. Neither FDA 

employees nor any Federal employee of 

any other Agency will have access to 

PII. All PII will be destroyed by 

contractors as soon as feasible following 

data collected during interviews. 

All electronic and hard-copy data will 

be maintained securely throughout the 

information collection and data 

processing phases. While under review, 

electronic data will be stored in locked 

files on secured computers; hard-copy 

data will be maintained in secure 

building facilities in locked filing 

cabinets. As a further guarantee of 

privacy and anonymity, all data will be 

reported to FDA in aggregate form, with 

no links to individuals preserved. 

Reports generated by this information 

collection will be used only for research 

purposes and for the development of 

communication messages. 

Social and behavioral testing efforts 

described in this proposal are typically 

considered exempt from the 

‘‘Regulations for the Protection of 

Human Subjects’’ in accordance with 45 

CFR 46.101(b)(3). Before data are 

collected, FDA researchers must obtain 

either an exemption or an expedited or 

full approval for all research from FDA’s 

institutional review board (IRB). 

When FDA’s IRB determines that 

minors are capable of giving assent, the 


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12486 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

IRB shall determine whether adequate 

provisions are made for soliciting 

assent. Generally, assent requires 

securing the signature of a minor 

potentially participating in the research 

on a separate assent form, in addition to 

the consent form the parent or legal 

guardian signs. An assent document 

should: (1) Contain an explanation of 

the study; (2) a description of what is 

required of the subject (e.g., what he or 

she will experience (whether the minor 

will be in the hospital, whether the 

minor’s parents will be with him or her, 

etc.)); (3) an explanation of any risks 

and pain associated with the study; (4) 

an explanation of any anticipated 

change in the minor’s appearance; and 

(5) an explanation of the benefits to the 

minor or others. 

FDA plans to use the data collected 

under the generic clearance to inform 

the following information for education, 

interventions, outcomes, regulatory 

science programs, materials and 

resources, and disease prevention and 

treatment. FDA expects the data to 

guide the formulation of the Agency’s 

educational and public health objectives 

on FDA-regulated products and support 

development of subsequent research 

efforts. The data will not be used to 

make policy or regulatory decisions. 

Rather, these data will: (1) Inform FDA’s 

public education campaigns and other 

educational/interventional materials 

directed to informing consumers, 

patients, caregivers, and public health 

professionals about human and animal 

health issues; and (2) provide 

information on the safety, efficacy, and 

usage of FDA-regulated products. 

If these conditions are not met, FDA 

will submit an information collection 

request to OMB for approval through the 

normal PRA process. 

To obtain approval for a collection 

that meets the conditions of this generic 

clearance, an abbreviated supporting 

statement will be submitted to OMB, 

along with supporting documentation 

(e.g., a copy of the interview or 

moderator guide, screening 

questionnaire). 

FDA will submit individual 

qualitative and quantitative collections 

under this generic clearance to the 

OMB. Individual collections will also 

undergo review by FDA’s IRB, senior 

leadership for the primary investigator’s 

respective offices, and PRA specialists. 

Description of Respondents: The 

respondents to this collection of 

information are all FDA stakeholders, 

including general population 

individuals, as well as consumers of 

certain products, patients and their 

caregivers, academic/scientific experts, 

individuals from specific target labor 

groups, such as physicians, medical 

specialists, pharmacists, dentists, 

nurses, veterinarians, dietitians, and 

other public health professionals. 

In the Federal Register of July 7, 2020 

(85 FR 40655), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

Although five comments were received, 

they were not responsive to the four 

collection of information topics 

solicited and, therefore, will not be 

discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Interviews/Surveys/Focus Groups ................................. 2,520 14.6 36,792 0.25 (15 minutes) 9,198 

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

This is a new collection of 

information whose total estimated 

annual reporting burden is 9,198 hours. 

The number of participants to be 

included in each individual generic 

submission under this collection of 

information will vary, depending on the 

nature of the compliance efforts and the 

target audience. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04407 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, NIAMS. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended for the review, discussion, 

and evaluation of individual intramural 

programs and projects conducted by the 

NATIONAL INSTITUTE OF ARTHRITIS 

AND MUSCULOSKELETAL AND SKIN 

DISEASES, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Board of Scientific 

Counselors, NIAMS. 

Date: April 27–28, 2021. 

Time: April 27, 2021, 12:30 p.m. to 4:45 

p.m. 

Agenda: To review and evaluate personnel 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 10 

Center Drive, Bethesda, MD 20892, (Virtual 

Meeting). 

Time: April 28, 2021, 12:00 p.m. to 4:15 

p.m. 

Agenda: To review and evaluate personnel 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 10 

Center Drive, Bethesda, MD 20892, (Virtual 

Meeting). 

Contact Person: John J. O’Shea, MD, Ph.D., 

Scientific Director, National Institute of 

Arthritis & Musculoskeletal and Skin 

Diseases, Building 10, Room 6N204, 

Bethesda, MD 20892, (301) 496–2612, 

osheajo@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: _February 25, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–04366 Filed 3–2–21; 8:45 am] 

BILLING CODE 4140–01–P 


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