48516 Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices 

the docket number, found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christian Hussong, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5261, Silver Spring, 

MD 20993–0002, 240–402–2246, 

Christian.Hussong@fda.hhs.gov or ELP 

Management, ELP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for ensuring the 

safety and effectiveness of medical 

devices marketed in the United States. 

Additionally, CDRH assures patients 

and providers have timely and 

continued access to high-quality, safe, 

and effective medical devices. Since 

CDRH has identified Partnering with 

Patients and Promoting a Culture of 

Quality and Organizational Excellence 

as strategic priorities, for the 2018 ELP, 

our goal is to specifically understand 

the perspective of our stakeholders and 

understand implementation of these 

topics within their institutions. The 

Center encourages applicants to 

consider including opportunities to 

discuss patient perspective and 

incorporating quality system design and 

management in their proposals as they 

contribute to the success of the device 

development life cycle. 

CDRH is committed to advancing 

regulatory science, providing industry 

with predictable, consistent, 

transparent, and efficient regulatory 

pathways, and helping to ensure 

consumer confidence in medical 

devices marketed in the United States 

and throughout the world. The ELP is 

intended to provide CDRH and other 

FDA staff with an opportunity to 

understand the laboratory and 

manufacturing practices, quality system 

management, patient perspective/input, 

and other challenges and how they 

impact the medical device development 

life cycle. ELP is a collaborative effort to 

enhance communication with our 

stakeholders to facilitate medical device 

reviews. The Center is committed to 

understanding current industry 

practices, innovative technologies, 

regulatory impacts and needs, and how 

patient perspective and quality systems 

management advances the development 

and evaluation of medical devices, and 

to monitor the performance of marketed 

devices. 

These formal training visits are not 

intended for FDA to inspect, assess, 

judge, or perform a regulatory function 

(e.g., compliance inspection), but rather, 

they are an opportunity to provide 

CDRH and other FDA staff a better 

understanding of the products they 

review, how they are developed, the 

voice of the patient, challenges related 

to quality systems development and 

management in the product life cycle, 

and how medical devices fit into the 

larger health care system. CDRH is 

formally requesting participation from 

industry, academia, and clinical 

facilities, medical device incubators and 

accelerators, health technology 

assessment groups, and those that have 

previously participated in the ELP or 

other FDA site visit programs. 

Additional information regarding the 

CDRH ELP, including the table of areas 

of interest, submission dates, a sample 

request, and an example of the site visit 

agenda, is available on CDRH’s Web site 

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

scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

II. CDRH ELP 

A. Areas of Interest 

In the ELP training program, groups of 

CDRH and other FDA staff will observe 

operations in the areas of research, 

device development, in making 

coverage decisions and assessments, 

incorporating patient information and 

reimbursement, manufacturing, and 

health care facilities. The areas of 

interest for visits include various topics 

identified by managers at CDRH and 

other areas within FDA. These areas of 

interest are listed on the ELP Web site 

and are intended to be updated 

quarterly. 

To submit a proposal addressing one 

of the Center’s training needs, visit the 

link for the table of areas of interest at: 

https://www.fda.gov/ScienceResearch/ 

ScienceCareerOpportunities/ 

UCM380676.htm. Once you have 

determined an area of interest to address 

in your ELP proposal, follow the 

instructions in section III to complete 

the site visit request template and 

agenda provided at: https://

www.fda.gov/downloads/ 

ScienceResearch/ 

ScienceCareerOpportunities/ 

UCM392988.pdf and at: https://

www.fda.gov/downloads/ 

ScienceResearch/ 

ScienceCareerOpportunities/ 

UCM487190.pdf. 

Submit all proposals at ELP@

fda.hhs.gov within the dates provided at 

the ELP Web site at: https://

www.fda.gov/scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

B. Site Selection 

CDRH and FDA will be responsible 

for its own staff travel expenses 

associated with the site visits. CDRH 

and FDA will not provide funds to 

support the training provided by the site 

to the ELP. Selection of potential 

facilities will be based on CDRH and 

FDA’s priorities for staff training and 

resources available to fund this 

program. In addition to logistical and 

other resource factors, all sites must 

have a successful compliance record 

with FDA or another Agency with 

which FDA has a memorandum of 

understanding (if applicable). If a site 

visit involves a visit to a separate 

physical location of another firm under 

contract with the site, that firm must 

agree to participate in the ELP and must 

also have a satisfactory compliance 

history, and must be listed in the 

proposal along with a Facility 

Establishment Identifier number, if 

applicable. 

III. Request To Participate 

Information regarding the CDRH ELP, 

including a sample request and an 

example of a site visit agenda, and 

submission dates is available on CDRH’s 

Web site at: https://www.fda.gov/ 

scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. Proposals to 

participate should be submitted to ELP@

fda.hhs.gov, within the dates provided, 

at the ELP Web site at https://

www.fda.gov/scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

Dated: October 13, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22626 Filed 10–17–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5569] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Device Tracking 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 


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announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection requirements for the tracking 

of medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 18, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 18, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 18, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–5569 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Devices; Device Tracking.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A63, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Devices; Device Tracking—21 

CFR Part 821 

OMB Control Number 0910–0442— 

Extension 

Section 211 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

became effective on February 19, 1998. 

FDAMA amended the previous medical 

device tracking provisions under section 

519(e)(1) and (2) of the Federal Food, 


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Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360i(e)(1) and (2)) that were 

added by the Safe Medical Devices Act 

of 1990 (SMDA) (Pub. L. 101–629). 

Unlike the tracking provisions under 

SMDA, which required tracking of any 

medical device meeting certain criteria, 

FDAMA allows FDA discretion in 

applying tracking provisions to medical 

devices meeting certain criteria and 

provides that tracking requirements for 

medical devices can be imposed only 

after FDA issues an order. In the Federal 

Register of February 8, 2002 (67 FR 

5943), FDA issued a final rule that 

conformed existing tracking regulations 

to changes in tracking provisions 

effected by FDAMA under part 821 (21 

CFR part 821). 

Section 519(e)(1) of the FD&C Act, as 

amended by FDAMA, provides that 

FDA may require by order that a 

manufacturer adopt a method for 

tracking a class II or III medical device, 

if the device meets one of the three 

following criteria: (1) The failure of the 

device would be reasonably likely to 

have serious adverse health 

consequences, (2) the device is intended 

to be implanted in the human body for 

more than 1 year (referred to as a 

‘‘tracked implant’’), or (3) the device is 

life-sustaining or life-supporting 

(referred to as a ‘‘tracked l/s-l/s device’’) 

and is used outside a device user 

facility. 

Tracked device information is 

collected to facilitate identifying the 

current location of medical devices and 

patients possessing those devices, to the 

extent that patients permit the 

collection of identifying information. 

Manufacturers and FDA (where 

necessary) use the data to: (1) Expedite 

the recall of distributed medical devices 

that are dangerous or defective and (2) 

facilitate the timely notification of 

patients or licensed practitioners of the 

risks associated with the medical 

device. 

In addition, the regulations include 

provisions for: (1) Exemptions and 

variances; (2) system and content 

requirements for tracking; (3) 

obligations of persons other than device 

manufacturers, e.g., distributors; (4) 

records and inspection requirements; (5) 

confidentiality; and (6) record retention 

requirements. 

Respondents for this collection of 

information are medical device 

manufacturers, importers, and 

distributors of tracked implants or 

tracked l/s-l/s devices used outside a 

device user facility. Distributors include 

multiple and final distributors, 

including hospitals. 

The annual hourly burden for 

respondents involved with medical 

device tracking is estimated to be 

615,380 hours per year. The burden 

estimates cited in tables 1 through 3 are 

based on the number of device tracking 

orders issued in the last 3 years, an 

average of 12 tracking orders annually. 

FDA estimates that approximately 

22,000 respondents may be subject to 

tracking reporting requirements. 

Under § 821.25(a), device 

manufacturers subject to FDA tracking 

orders must adopt a tracking method 

which can provide certain device, 

patient, and distributor information to 

FDA within 3 to 10 working days. 

Assuming one occurrence per year, FDA 

estimates it would take a firm 20 hours 

to provide FDA with location data for 

all tracked devices and 56 hours to 

identify all patients and/or multiple 

distributors possessing tracked devices. 

Under § 821.25(d) manufacturers must 

notify FDA of distributor 

noncompliance with reporting 

requirements. Based on the number of 

audits manufacturers conduct annually, 

FDA estimates it would receive no more 

than one notice in any year, and that it 

would take 1 hour per incident. 

Under § 821.30(c)(2), multiple 

distributors must provide data on 

current users of tracked devices, current 

device locations, and other information, 

upon request from a manufacturer or 

FDA. FDA has not made such a request 

and is not aware of any manufacturer 

making a request. Assuming one 

multiple distributor receives one request 

in a year from either a manufacturer or 

FDA, and that lists may be generated 

electronically, the Agency estimates a 

burden of 1 hour to comply. 

Under § 821.30(d) distributors must 

verify data or make required records 

available for auditing, if a manufacturer 

provides a written request. FDA’s 

estimate of the burden for distributor 

audit responses assumes that 

manufacturers audit database entries for 

5 percent of tracked devices distributed. 

Each audited database entry prompts 

one distributor audit response. Because 

lists may be generated electronically, 

FDA estimates a burden of 1 hour to 

comply. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Discontinuation of business—821.1(d) ................................ 1 1 1 1 1 

Exemption or variance—821.2 and 821.30(e) ..................... 1 1 1 1 1 

Notification of failure to comply—821.25(d) ........................ 1 1 1 1 1 

Multiple distributor data—821.30(c)(2) ................................ 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 4 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Tracking information—821.25(a) ......................................... 12 1 12 76 912 

Record of tracking data—821.25(b) .................................... 12 46,260 555,120 1 555,120 

Standard operating procedures—821.25(c) 2 ...................... 12 1 12 63 756 

Manufacturer data audit—821.25(c)(3) ................................ 12 1,124 13,488 1 13,488 

Multiple distributor data and distributor tracking records— 

821.30(c)(2) and (d) ......................................................... 22,000 1 22,000 1 22,000 


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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Total .............................................................................. ........................ ........................ ........................ ........................ 592,276 

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

2One-time burden. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Acquisition of tracked devices and final distributor data— 

821.30(a) and (b) ............................................................. 22,000 1 22,000 1 22,000 

Multiple distributor data and distributor tracking records— 

821.30(c)(2) and (d) ......................................................... 1,100 1 1,100 1 1,100 

Total .............................................................................. ........................ ........................ ........................ ........................ 23,100 

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

The burden estimate for this 

information collection has not changed 

since the last OMB approval. 

This document also 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 under the PRA 

(44 U.S.C. 3501–3520). The collections 

of information found in §§ 821.2(b), 

821.25(e), and 821.30(e) have been 

approved under OMB control number 

0910–0191. 

Dated: October 11, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22550 Filed 10–17–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

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

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; SBIR/STTR 

Applications in Drug Discovery and 

Development. 

Date: November 13, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Sergei Ruvinov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4158, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1180, ruvinser@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR PanelNeural Regulation of Cancer. 

Date: November 13, 2017. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Manzoor Zarger, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6208, 

MSC 7804, Bethesda, MD 20892, (301) 435– 

2477, zargerma@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Vascular 

and Hematology. 

Date: November 13, 2017. 

Time: 2:00 p.m. to 4:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Larry Pinkus, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4132, 

MSC 7802, Bethesda, MD 20892, (301) 435– 

1214, pinkusl@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; ParasitesVectors and Fungi. 

Date: November 14–15, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Fouad A El-Zaatari, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3186, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

1149, elzaataf@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Biomaterials, Delivery, and Nanotechnology. 

Date: November 14–15, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: Hilton Washington DC/Rockville, 

1750 Rockville Pike, Rockville, MD 20852. 

Contact Person: Nitsa Rosenzweig, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4152, 

MSC 7760, Bethesda, MD 20892, (301) 404– 

7419, rosenzweign@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR 17– 

094: Maximizing Investigator’s Research 

Award (R35). 

Date: November 14, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Maqsood A Wani, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2114, 


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