Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 28257 

Exhibit 2. Estimated Annualized Cost 

Burden 

Type of data collection Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate * 

Total cost 

burden 

Focus Groups .......................................................................................... 1,056 1,584 $48.98 $77,584 

In-person/Telephone Interviews .............................................................. 1,386 3,050 46.82 142,801 

Customer Satisfaction Surveys for the Decision Aid ............................... 550 184 25.53 4,698 

Customer Satisfaction Surveys for the Summary Guides ....................... 6,600 550 39.55 21,753 

Follow-up CME Surveys .......................................................................... 1,320 110 77.64 8,540 

Solicited Topic Nominations .................................................................... 2,500 208 48.07 9,999 

Web site Registration .............................................................................. 6,000 500 48.07 24,035 

Glossary Feedback Survey ..................................................................... 200 17 48.07 817 

Total .................................................................................................. 19,612 6,203 (1) 290,227 

1 Not applicable. 

* Based upon the mean and weighted mean wages for clinicians (29–1062 family and general practitioners), policy makers (11–0000 management occupations, 11–3041 compensation & benefits managers, 13–1072 compensation, benefits & job analysis specialists, 11–9111 medical 

and health service managers, 13–2053 insurance underwriters and 15–2011 actuaries) and consumers (00–0000 all occupations). Focus groups 

include 528 clinicians ($77.64/hr) and 528 consumers ($20.32/hr); in-person/telephone interviews includes 528 clinicians, 330 policy makers 

($39.91/hr) and 528 consumers; customer satisfaction surveys for the decision aid includes 50 clinicians and 500 consumers; customer satisfaction surveys for the summary guides includes 1,650 clinicians, 1,650 policy makers and 3,300 consumers; follow-up CME surveys includes 1,320 

clinicians; solicited topic nominations include 1,125 clinicians, 250 policy makers and 1,125 consumers; Web site registration includes 2,700 clinicians, 600 policy makers and 2,700 consumers; glossary feedback survey includes 90 clinicians, 20 policy makers and 90 consumers, National 

Compensation Survey: Occupational wages in the United States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

The maximum cost to the Federal 

Government is estimated to be 

$1,439,003 annually. Exhibit 3 shows 

the total and annualized cost by the 

major cost components. 

Exhibit 3. Estimated Total and 

Annualized Cost 

Cost component Total 

cost 

Annualized 

cost 

Project Development ....................................................................................................................................................... $1,019,970 $339,990 

Data Collection Activities ................................................................................................................................................. 735,405 245,135 

Data Processing and Analysis ......................................................................................................................................... 1,889,505 629,835 

Project Management ........................................................................................................................................................ 557,380 185,793 

Overhead ......................................................................................................................................................................... 114,750 38,250 

Total .......................................................................................................................................................................... 4,317,010 1,439,003 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ healthcare research and 

healthcare information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: May 10, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–11993 Filed 5–19–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0226] 

Draft Guidance for Industry, Third 

Parties and Food and Drug 

Administration Staff; Medical Device 

ISO 13485:2003 Voluntary Audit Report 

Submission Program; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Medical Device ISO 

13485:2003 Voluntary Audit Report 

Submission Program.’’ This draft 

guidance is intended to provide 

information on the implementation of a 

section of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA), which amends a section 

of the Federal Food, Drug, and Cosmetic 

Act (the act). This guidance document 

describes how FDA’s Center for Devices 

and Radiological Health (CDRH) and 

Center for Biologics Evaluation and 

Research (CBER) are implementing this 

provision of the law. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
28258 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 

1The GHTF founding members auditing systems 

include the Canadian Medical Devices Conformity 

Assessment System; the European Union Notified 

Body accreditation system; the Therapeutics Goods 

Administration of Australia Inspectorate; and the 

Japanese Medical Device Ministry of Health, Labour 

and Welfare system. 

written or electronic comments on the 

draft guidance by August 18, 2010. 

Submit written or electronic comments 

on the collection of information July 19, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Medical Device ISO 

13485:2003 Voluntary Audit Report 

Submission Program’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (DSMICA), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Room 

4613, Silver Spring, MD 20993 or to the 

Office of Communications, Outreach 

and Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448. The draft guidance 

may also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly A. Trautman, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Room 3422, 

Silver Spring, MD 20993, 301–796– 

5515, or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance is intended to 

provide information on the 

implementation of section 228 of 

FDAAA, which amends section 

704(g)(7) of the act (21 U.S.C. 374(g)(7)). 

Under this draft guidance, device 

manufacturers whose establishment has 

been audited under one of the 

regulatory systems implemented by the 

Global Harmonization Task Force 

(GHTF) founding members1 using ISO 

13485:2003 ‘‘Medical devices—Quality 

management systems—Requirements for 

regulatory purposes,’’ may voluntarily 

submit the resulting audit report to 

FDA. If, based on that report, FDA 

determines there is minimal 

probability—in light of the relationship 

between the quality system deficiencies 

observed and the particular device and 

manufacturing processes involved—that 

the establishment will produce 

nonconforming and/or defective 

finished devices, then FDA intends to 

use the audit results as part of its risk 

assessment to determine whether that 

establishment can be removed from 

FDA’s routine work plan for 1 year. The 

medical device ISO 13485:2003 

Voluntary Audit Report Submission 

Program outlined in this draft guidance 

is another way in which FDA may 

leverage audits performed by other 

GHTF regulators and accredited third 

parties in order to assist the agency in 

setting risk-based inspectional 

priorities. 

This notice of availability and draft 

guidance satisfy the public notice 

requirement of section 704(g)(7)(F) of 

the act, which provides that FDA shall 

give public notice of the ISO standard(s) 

under which FDA accepts voluntary 

submissions of audit reports. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on ‘‘Medical Device ISO 13485:2003 

Voluntary Audit Report Submission 

Program.’’ It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Draft Guidance 

for Industry, Third Parties and FDA 

Staff: Medical Device ISO 13485:2003 

Voluntary Audit Report Submission 

Program’’ you may either send an e-mail 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1705 to 

identify the guidance you are 

requesting. 

A search capability for all CDRH 

guidance documents is available at 

http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov or at 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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. 

Title: Draft Guidance for Industry, 

Third Parties and FDA Staff: Medical 

Device ISO 13485:2003 Voluntary Audit 

Report Submission Program. 

Description: Section 228 of the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA), amended section 

704(g)(7) of the Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

374(g)(7)) to add the following 

provision: 

‘‘(F) For the purpose of setting riskbased inspectional priorities, the 

Secretary shall accept voluntary 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 28259 

2The majority of these manufacturers are also 

certified under ISO 13485:2003 by the European 

Union Notified Body accreditation system. 

submissions of reports of audits 

assessing conformance with appropriate 

quality system standards set by the 

International Organization for 

Standardization (ISO) and identified by 

the Secretary in public notice. If the 

owner or operator of an establishment 

elects to submit audit reports under this 

subparagraph, the owner or operator 

shall submit all such audit reports with 

respect to the establishment during the 

preceding 2-year periods.’’ 

The ‘‘Draft Guidance for Industry, 

Third Parties and FDA Staff: Medical 

Device ISO 13485:2003 Voluntary Audit 

Report Submission Program’’ will 

describe how FDA’s CDRH and CBER 

are implementing this provision of the 

law and providing public notice as 

required. The proposed collections of 

information are necessary to satisfy the 

previously mentioned statutory 

requirements for implementing this 

voluntary submission program. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Type of Respondent No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Domestic or foreign device manufacturer 

whose establishment was audited under 

ISO 13485:2003 1,600 1 1,600 2 3,200 

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

Based on FDA’s experience with the 

founding regulatory members of GHTF, 

FDA expects that the vast majority of 

manufacturers who will participate in 

the Voluntary Audit Report Submission 

Program will be manufacturers who are 

certified by Health Canada under ISO 

13485:2003.2 In 2008, approximately 

2,650 manufacturers or manufacturing 

sites had been certified by Health 

Canada. 

In addition, FDA only expects firms 

who do not have major deficiencies or 

observations in their ISO 13485:2003 

audits to be willing to submit their audit 

reports to FDA under the Voluntary 

Audit Report Submission Program. FDA 

analyzed its inspection data from Fiscal 

Year (FY) 2008 (October 1, 2007 to 

October 1, 2008) and determined that 

the total number of inspections finalized 

in FY2008 for medical devices was 

1,965. The breakdown for the 1,965 

compliance decisions is as follows: 

TABLE 2.—COMPLIANCE DECISION BREAKDOWN

Compliance Decision1 Number Approximate Percentage 

Official Action Indicated 148 8% 

Voluntary Action Indicated 775 40% 

No Action Indicated 1,025 52% 

Pending Final Decision 17 1% 

1 June 15, 2006, Compliance Program 7382.845 Inspection of Medical Device Manufacturers Part V http://www.fda.gov/cdrh/comp/guidance/ 

7382.845.html#p5p5.pdf. 

Because FDA only expects firms who 

do not have major deficiencies or 

observations to be willing to submit 

their audit reports to FDA under the 

Voluntary Audit Report Submission 

Program, FDA only expects to receive 

audit reports that would have been 

classified by FDA as No Action 

Indicated (NAI). 

Assuming that the percentage 

breakdown of compliance decisions for 

all inspections conducted in FY2008 

can be extrapolated and applied to 

audits of manufacturers certified under 

ISO 13485:2003 by Health Canada, FDA 

can estimate the number of Canadian 

establishments that would have had an 

inspection classified as an NAI. Since 

52 percent of all compliance decisions 

resulted in a NAI decision, FDA 

estimates that 1,378 of the facilities 

certified under ISO 13485:2003 by 

Health Canada (52 percent of the total 

2,650 facilities) would have had an 

inspection classified as an NAI. Since 

FDA only expects to receive audit 

reports that would have been classified 

by FDA as NAI, FDA expects 1,378, or 

approximately 1,400, audit reports to be 

submitted. 

Since FDA expects that the vast 

majority of manufacturers who will 

participate in the Voluntary Audit 

Report Submission Program will be 

manufacturers certified by Health 

Canada under ISO 13485:2003, FDA 

expects the number of reports to be 

submitted from manufacturers certified 

by regulatory systems established by 

other founding GHTF members to be 

minimal. For purposes of calculating the 

reporting burden, FDA estimates that 

approximately 10 percent of total audit 

reports submitted under this program 

will be from these other manufacturers. 

Since 90 percent of the audit reports are 

expected to be submitted by 

manufacturers certified by Health 

Canada (approximately 1,400 audit 

reports as calculated previously in this 

document), then the total number of 

audit reports FDA expects to receive in 

a year is 1,556, or approximately 1,600, 

audit reports. 

FDA further estimates that the 

gathering, scanning, and submission of 

the audit reports, certificates, and 

related correspondence would take 

approximately 2 hours. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by OMB under the 

PRA. The collections of information in 

21 CFR part 820 have been approved 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
28260 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 

under OMB control number 0910–0073 

and the collections of information for 

the Inspection by Accredited Persons 

Program have been approved under 

OMB control number 0910–0569. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: May 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–12098 Filed 5–19–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Arthritis and Musculoskeletal 

and Skin Diseases Advisory Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting 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: National Arthritis and 

Musculoskeletal and Skin Diseases Advisory 

Council. 

Date: June 15, 2010. 

Open: 8:30 a.m. to 12 p.m. 

Agenda: To discuss administrative details 

relating to the Council’s business and special 

reports. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Closed: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Contact Person: Laura K. Moen, PhD, 

Director, Division of Extramural Research 

Activities, NIAMS/NIH, 6701 Democracy 

Blvd., Ste. 800, Bethesda, MD 20892, 301– 

451–6515, moenl@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: May 14, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–12151 Filed 5–19–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Mechanisms of Protein 

Homeostasis. 

Date: June 14, 2010. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, 3201, Bethesda, MD 20817. 

(Telephone Conference Call) 

Contact Person: Brandt R. Burgess, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethdesda, MD 

20892–7616, 301–451–2584, 

bburgess@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Emergence and Evolution of 

Coronavirus Pathogens. 

Date: June 15, 2010. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, 3201, Bethesda, MD 20817. 

(Telephone Conference Call) 

Contact Person: Brandt R. Burgess, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethdesda, MD 

20892–7616, 301–451–2584, 

bburgess@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: May 14, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–12156 Filed 5–19–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1