Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44417 

accredits are ‘‘deemed’’ to meet the 

CLIA requirements based on this 

accreditation. Similarly, if a State 

licensure program is determined to have 

requirements that are equal to or more 

stringent than those of CLIA, its 

laboratories are considered to be exempt 

from CLIA certification and 

requirements. The information collected 

will be used by HHS to: Determine 

comparability/equivalency of the 

accreditation organization standards 

and policies or State licensure program 

standards and policies to those of the 

CLIA program; to ensure the continued 

comparability/equivalency of the 

standards; and to fulfill certain statutory 

reporting requirements. Form No.: 

CMS–R–185 (OMB control number: 

0938–0686); Frequency: Occasionally; 

Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 12; Total Annual 

Responses: 96; Total Annual Hours: 

384. (For policy questions regarding this 

collection contact Arlene Lopez at 410– 

786–6782.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Business 

Proposal Forms for Quality 

Improvement Organizations (QIOs); Use: 

The submission of proposal information 

by current quality improvement 

associations (QIOs) and other bidders, 

on the appropriate forms, will satisfy 

our need for meaningful, consistent, and 

verifiable data with which to evaluate 

contract proposals. We use the data 

collected on the forms associated with 

this information collection request to 

negotiate QIO contracts. We will be able 

to compare the costs reported by the 

QIOs on the cost reports to the proposed 

costs noted on the business proposal 

forms. Subsequent contract and 

modification negotiations will be based 

on historic cost data. The business 

proposal forms will be one element of 

the historical cost data from which we 

can analyze future proposed costs. In 

addition, the business proposal format 

will standardize the cost proposing and 

pricing process among all QIOs. With 

well-defined cost centers and line items, 

proposals can be compared among QIOs 

for reasonableness and appropriateness. 

Form Number: CMS–718–721 (OMB 

control number: 0938–0579); Frequency: 

Annually; Affected Public: Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

20; Total Annual Responses: 20; Total 

Annual Hours: 1,000. (For policy 

questions regarding this collection 

contact Benjamin Bernstein at 410–786– 

6570.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Fast Track 

Appeals Notices: NOMNC/DENC; Use: 

Providers shall deliver a Notice of 

Medicare (Provider) Non-Coverage 

(NOMNC) to beneficiaries, enrollees, or 

both beneficiaries and enrollees no later 

than two days prior to the end of 

Medicare-covered services in skilled 

nursing facilities, home health agencies, 

comprehensive outpatient rehabilitation 

facilities, and hospices. Beneficiaries, 

enrollees or both beneficiaries and 

enrollees will use this information to 

determine whether they want to appeal 

the service termination to their Quality 

Improvement Organization (QIO). If the 

beneficiaries, enrollees or both 

beneficiaries decide to appeal, the 

Medicare provider or health plan will 

send the QIO and appellant a Detailed 

Explanation of Non-Coverage (DENC) 

detailing the rationale for the 

termination decision. Form Number: 

CMS–10123 and CMS–10124 (OMB 

control number: 0938–0953); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 28,177; Total Annual 

Responses: 6,017,832; Total Annual 

Hours: 1,111,196. (For policy questions 

regarding this collection contact Janet 

Miller at 404–562–1799.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Bid Pricing Tool 

(BPT) for Medicare Advantage (MA) 

Plans and Prescription Drug Plans 

(PDP); Use: We require that Medicare 

Advantage organizations and 

Prescription Drug Plans complete the 

BPT as part of the annual bidding 

process. During this process, 

organizations prepare their proposed 

actuarial bid pricing for the upcoming 

contract year and submit them to us for 

review and approval. The purpose of the 

BPT is to collect the actuarial pricing 

information for each plan. The BPT 

calculates the plan’s bid, enrollee 

premiums, and payment rates. We 

publish beneficiary premium 

information using a variety of formats 

(www.medicare.gov, the Medicare & You 

handbook, Summary of Benefits 

marketing information) for the purpose 

of beneficiary education and 

enrollment. Form Number: CMS–10142 

(OMB control number: 0938–0944); 

Frequency: Yearly; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 555; Total Annual 

Responses: 4,995; Total Annual Hours: 

149,850. (For policy questions regarding 

this collection contact Rachel Shevland 

at 410–786–3026.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Contract Year 

2019 Plan Benefit Package (PBP) 

Software and Formulary Submission; 

Use: We require that Medicare 

Advantage and Prescription Drug Plan 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to us for 

review and approval. We publish 

beneficiary education information using 

a variety of formats. The specific 

education initiatives that utilize PBP 

and formulary data include web 

application tools on www.medicare.gov 

and the plan benefit insert in the 

Medicare & You handbook. In addition, 

organizations utilize the PBP data to 

generate their Summary of Benefits 

marketing information. Form Number: 

CMS–R–262 (OMB control number 

0938–0763); Frequency: Yearly; Affected 

Public: Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 520; Total Annual 

Responses: 5,675; Total Annual Hours: 

54,550. (For policy questions regarding 

this collection contact Kristy Holtje at 

410–786–2209.) 

Dated: September 19, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–20290 Filed 9–21–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0275] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Certification To 

Accompany Drug, Biological Product, 

and Device Applications or 

Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

44418 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

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 

the requirements for certain FDA 

applications or submissions to be 

accompanied by a certification, Form 

FDA 3674, to ensure all applicable 

statutory requirements have been met. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 21, 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 November 21, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 21, 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– 

2011–N–0275 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Certification to Accompany Drug, 

Biological Product, and Device 

Applications or Submissions.’’ 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, 10A–12M, 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. 

Certification To Accompany Drug, 

Biological Product, and Device 

Applications or Submissions (Form 

FDA 3674) 

OMB Control Number 0910–0616— 

Extension 

The information required under 

section 402(j)(5)(B) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44419 

282(j)(5)(B)) is submitted in the form of 

a certification, Form FDA 3674, which 

accompanies applications and 

submissions currently submitted to FDA 

and already approved by OMB. The 

OMB control numbers and expiration 

dates for those applications and 

submissions are: 21 CFR parts 312 and 

314 (human drugs), OMB control 

number 0910–0014, expiring February 

28, 2019, and OMB control number 

0910–0001, expiring December 31, 2017; 

21 CFR parts 312 and 601 (biological 

products), OMB control number 0910– 

0014, expiring February 28, 2019, and 

OMB control number 0910–0338, 

expiring March 31, 2020; 21 CFR parts 

807 and 814 (devices), OMB control 

number 0910–0120, expiring June 30, 

2020, and OMB control number 0910– 

0231, expiring March 31, 2020. 

Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Pub. L. 110–85) 

amended the PHS Act by adding section 

402(j). The provisions broadened the 

scope of clinical trials subject to 

submitting information and required 

additional information to be submitted 

to the clinical trials databank (https://

clinicaltrials.gov/) (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register) 

previously established by the National 

Institutes of Health (NIH)/National 

Library of Medicine. This includes 

expanded information on applicable 

clinical trials and summary information 

on the results of certain clinical trials. 

The provisions include responsibilities 

for FDA as well as several amendments 

to the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). 

One provision, section 402(j)(5)(B) of 

the PHS Act, requires that a certification 

accompany human drug, biological, and 

device product submissions made to 

FDA. Specifically, at the time of 

submission of an application under 

sections 505, 515, or 520(m) of the 

FD&C Act (21 U.S.C. 355, 360e, or 

360j(m)), or under section 351 of the 

PHS Act (42 U.S.C. 262), or submission 

of a report under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)), such 

application or submission must be 

accompanied by a certification, Form 

FDA 3674, that all applicable 

requirements of section 402(j) of the 

PHS Act have been met. Where 

available, such certification must 

include the appropriate National 

Clinical Trial (NCT) numbers that are 

assigned upon submission of required 

information to the NIH databank at 

https://clinicaltrials.gov/. 

The proposed extension of the 

collection of information is necessary to 

satisfy the previously mentioned 

statutory requirement. The importance 

of obtaining these data relates to 

adherence to the legal requirements for 

submissions to the clinical trials registry 

and results data bank and ensuring that 

individuals and organizations 

submitting applications or reports to 

FDA under the listed provisions of the 

FD&C Act or the PHS Act adhere to the 

appropriate legal and regulatory 

requirements for certifying to having 

complied with those requirements. The 

failure to submit the certification 

required by section 402(j)(5)(B) of the 

PHS Act, and the knowing submission 

of a false certification, are both 

prohibited acts under section 301 of the 

FD&C Act (21 U.S.C. 331). Violations are 

subject to civil money penalties. The 

Form FDA 3674 provides a convenient 

mechanism for sponsors/applicants/ 

submitters to satisfy the certification 

requirements of the statutory provision. 

To assist sponsors/applicants/ 

submitters in understanding the 

statutory requirements associated with 

Form FDA 3674, we have provided a 

guidance available at: https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125335.htm. This 

guidance recommends the applications 

and submissions FDA considers should 

be accompanied by the certification 

form, Form FDA 3674. The applications 

and submissions identified in the 

guidance are reflected in the burden 

analysis. In 2017, we updated the 

guidance to include references to the 

NIH Final Rule implementing 402(j) of 

the PHS Act (42 U.S.C. 282(j)). The 

Final Rule, published on September 21, 

2016 (42 CFR part 11), clarifies the 

requirements for submission of clinical 

trial information to https://

clinicaltrials.gov/. 

Investigational New Drug 

Applications. FDA’s Center for Drug 

Evaluation and Research (CDER) 

received 1,669 investigational new drug 

applications (INDs) and 15,285 clinical 

protocol IND amendments in calendar 

year (CY) 2016. CDER anticipates that 

IND and clinical protocol amendment 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Biologics Evaluation 

and Research (CBER) received 381 new 

INDs and 456 clinical protocol IND 

amendments in CY 2016. CBER 

anticipates that IND and clinical 

protocol amendment submission rates 

will remain at or near this level in the 

near future. The estimated total number 

of submissions (new INDs and new 

protocol submissions) subject to 

mandatory certification requirements 

under section 402(j)(5)(B) of the PHS 

Act, is 16,954 for CDER plus 837 for 

CBER, or 17,791 submissions per year. 

The minutes per response is the 

estimated number of minutes that a 

respondent would spend preparing the 

information to be submitted to FDA 

under section 402(j)(5)(B) of the PHS 

Act, including the time it takes to enter 

the necessary information on the form. 

Based on its experience with current 

submissions, FDA estimates that 

approximately 15 minutes on average 

would be needed per response for 

certifications that accompany IND 

applications and clinical protocol 

amendment submissions. It is assumed 

that most submissions to investigational 

applications will reference only a few 

protocols for which the sponsor/ 

applicant/submitter has obtained a NCT 

number from https://clinicaltrials.gov/ 

prior to making the submission to FDA. 

It is also assumed that the sponsor/ 

applicant/submitter has electronic 

capabilities allowing them to retrieve 

the information necessary to complete 

the form in an efficient manner. 

Marketing Applications/Submissions. 

In CY 2016, CDER and CBER received 

252 new drug applications (NDA)/ 

biologics license applications (BLA)/ 

resubmissions and 1,067 NDA/BLA 

amendments for which certifications are 

needed. CDER and CBER received 253 

efficacy supplements/resubmissions to 

previously approved NDAs/BLAs in CY 

2016. CDER and CBER anticipate that 

new drug/biologic applications/ 

resubmissions and efficacy supplement 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Devices and 

Radiological Health (CDRH) received a 

total of 330 new applications for 

premarket approvals (PMA), 510(k) 

submissions containing clinical 

information, PMA supplements, 

applications for humanitarian device 

exemptions (HDE) and amendments in 

CY 2016. CDRH anticipates that 

application, amendment, supplement, 

and annual report submission rates will 

remain at or near this level in the near 

future. 

FDA’s Office of Generic Drugs (OGD) 

received 1,036 abbreviated new drug 

applications (ANDAs) in 2016. OGD 

received 698 bioequivalence 

amendments/supplements in 2016. OGD 

anticipates that application, 

amendment, and supplement 

submission rates will remain at or near 

this level in the near future. 

Based on its experience reviewing 

NDAs, BLAs, PMAs, HDEs, 510(k)s, and 

ANDAs and experience with current 

submissions of Form FDA 3674, FDA 

estimates that approximately 45 minutes 

44420 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

on average would be needed per 

response for certifications which 

accompany NDA, BLA, PMA, HDE, 

510(k), and ANDA marketing 

applications and submissions. It is 

assumed that the sponsor/applicant/ 

submitter has electronic capabilities 

allowing them to retrieve the 

information necessary to complete the 

form in an efficient manner. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center activity 

Number of 

respondents 

(investigational 

applications) 

Number of 

respondents 

(marketing 

applications) 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER 

New Applications (IND) ................ 1,669 ........................ 1 1,669 0.25 (15 minutes) .. 417 

Clinical Protocol Amendments 

(IND).

15,285 ........................ 1 15,285 0.25 (15 minutes) .. 3,821 

New Marketing Applications/Resubmissions (NDA/BLA)............................. 198 1 198 0.75 (45 minutes) .. 149 

Clinical Amendments to Marketing 

Applications.

............................ 1,067 1 1,067 0.75 (45 minutes) .. 800 

Efficacy Supplements/Resubmissions............................. 219 1 219 0.75 (45 minutes) .. 164 

CBER 

New Applications (IND) ................ 381 ........................ 1 381 0.25 (15 minutes) .. 95 

Clinical Protocol Amendments 

(IND).

456 ........................ 1 456 0.25 (15 minutes) .. 114 

New Marketing Applications/Resubmissions (NDA/BLA)............................. 54 1 54 0.75 (45 minutes) .. 41 

Clinical Amendments to Marketing 

Applications.

............................ 0 1 0 0.75 (45 minutes) .. 0 

Efficacy Supplements/Resubmissions (BLA only)............................. 34 1 34 0.75 (45 minutes) .. 26 

CDRH 

New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to 

contain clinical data).

............................ 330 1 330 0.75 (45 minutes) .. 247 

OGD 

Original Applications ..................... ............................ 1,036 1 ........................ 0.75 (45 minutes) .. 777 

Bioequivalence Supplements/ 

Amendments.

............................ 698 1 ........................ 0.75 (45 minutes) .. 524 

Total ...................................... ............................ ........................ ........................ ........................ ............................... 7,175 

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

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20227 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0622] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Color Additive 

Certification Requests and 

Recordkeeping 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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: Fax written comments on the 

collection of information by October 23, 

2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0216. Also 

include the FDA docket number found 

in brackets in the heading of this 

document.