Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 62161 

to develop and support FDA’s policies 

related to tobacco products, including 

their labels, labeling, and advertising. 

Data will be collected from the panel 

primarily through the use of 

randomized experimental designs, 

however, there may be data collected 

through the use of other methods, such 

as surveys, interviews, or online group 

discussions. Given the limitations on 

the existing Web-based panels, it is 

important to develop a new panel of 

tobacco users that balances the need to 

conduct experiments while limiting the 

number of tobacco-related studies per 

year so as to not bias study results. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity or type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Household Screening Respondent .............................. 29,385 0.33 9,697 0.16 (10 minutes) ... 1,552 

Panel Member Enrollment Survey .............................. 4,000 0.33 1,320 0.25 (15 minutes) .. 330 

Panel Member Baseline Survey .................................. ........................ 0.33 1,320 0.25 (15 minutes) ... 330 

Panel Maintenance/Bi-annual Update Surveys ........... ........................ 3.0 12,000 0.08 (5 minutes) ..... 960 

Experimental/Observational Studies * ......................... ........................ 2.7 10,800 0.33 (20 minutes) ... 3,564 

Panel Replenishment Screening Respondent ............ 10,285 0.50 5,143 0.16 (10 minutes) ... 823 

Panel Replenishment Enrollment Survey ** ................ 2,800 0.33 924 0.25 (15 minutes) ... 231 

Panel Replenishment Baseline Survey ** .................... 2,800 0.33 924 0.25 (15 minutes) .. 231 

Cognitive Interview Subjects ....................................... 20 0.33 7 1.0 .......................... 7 

Focus Group Subjects ................................................. 20 0.33 7 1.5 .......................... 10 

Total ...................................................................... 49,310 ........................ ........................ ................................ 8,038 

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

* Includes a total of 8 experimental or observational studies over a 3-year period for each of the 4,000 panel members who are active at the 

time of each study. The first study (Study 1) is included in this clearance request; the remaining studies will be funded under separate task orders but are included in this table to present an overall estimate of the burden for each participating panel member. **Assumes 1,400 additional panel members will be recruited annually (2,800 total) as part of the panel replenishment effort. 

The burden above was estimated 

using data from timed-readings of each 

instrument, including the mail and field 

screeners, enrollment survey, baseline 

survey, panel maintenance 

questionnaires, and Study 1 

questionnaire. 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24538 Filed 10–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0555] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Device Tracking 

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 November 

17, 2014. 

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 0910–0442. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

Medical Devices; Device Tracking—21 

CFR part 821 (OMB Control Number 

0910–0442)—Extension 

Section 211 of the Food and Drug 

Administration Modernization Act 

(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 (e)(2) of the Federal Food, 

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

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


asabaliauskas on DSK5VPTVN1PROD with NOTICES
62162 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 

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 to 3 of this 

document are based on the number of 

device tracking orders issued in the last 

3 years. 

This regulation 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 

0910–0183. 

In the Federal Register of April 25, 

2014 (79 FR 22991), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR part 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 part 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 

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 part 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 

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


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 62163 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24599 Filed 10–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1675] 

New Chemical Entity Exclusivity 

Determinations for Certain FixedCombination Drug Products; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘New Chemical Entity 

Exclusivity Determinations for Certain 

Fixed-Combination Drug Products.’’ 

This guidance sets forth a change in the 

Agency’s interpretation of the 5-year 

new chemical entity (NCE) exclusivity 

statutory and regulatory provisions as 

they apply to certain fixed-combination 

drug products (fixed combinations). As 

described in the guidance, a drug 

product will be eligible for 5-year NCE 

exclusivity if it contains a drug 

substance that meets the definition of 

‘‘new chemical entity,’’ regardless of 

whether that drug substance is approved 

in a single-ingredient drug product or in 

certain fixed-combinations. This 

guidance finalizes the draft guidance 

issued in February 2014. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Nisha Shah, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6222, Silver Spring, 

MD 20993–0002, 301–796–4455; or Jay 

Sitlani, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6272, Silver Spring, 

MD 20993–0002, 301–796–5202. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘New 

Chemical Entity Exclusivity 

Determinations for Certain FixedCombination Drug Products.’’ This 

guidance sets forth a change in the 

Agency’s interpretation of the 5-year 

NCE exclusivity provisions as they 

apply to certain fixed-combinations. 

Section 505(c)(3)(E)(ii) and (j)(5)(F)(ii) of 

the Food, Drug, and Cosmetic Act and 

21 CFR 314.108, among other 

provisions, establish the scheme under 

which a drug product is eligible for 5- 

year NCE exclusivity. The Agency 

historically interpreted the term ‘‘drug’’ 

as it appears in the first sub-clause of 

the statutory provisions and in the 

definition of ‘‘new chemical entity’’ in 

its regulation to mean ‘‘drug product.’’ 

This resulted in a fixed-combination not 

being eligible for 5-year NCE exclusivity 

if it contained any drug substance that 

contained an active moiety that had 

been previously approved by the 

Agency, even if the fixed-combination 

also contained another drug substance 

that contained a previously unapproved 

active moiety. 

The Agency recognizes, however, that 

fixed-combinations have become 

increasingly prevalent in certain 

therapeutic areas and that these 

products play an important role in 

optimizing adherence to dosing 

regimens and improving patient 

outcomes. Therefore, to further 

incentivize the development of fixedcombinations containing previously 

unapproved active moieties, the 

guidance sets forth the Agency’s revised 

interpretation regarding the eligibility 

for 5-year NCE exclusivity of certain 

fixed-combinations. Under the revised 

interpretation, the term ‘‘drug’’ in the 

relevant provisions is interpreted to 

mean ‘‘drug substance’’ or ‘‘active 

ingredient,’’ and not ‘‘drug product.’’ 

Accordingly, a drug product is eligible 

for 5-year NCE exclusivity provided that 

it contains a drug substance that 

contains no active moiety that has been 

previously approved. This will permit a 

drug substance that meets the definition 

of new chemical entity (i.e., one that 

contains no previously approved active 

moiety) to be eligible for 5-year NCE 

exclusivity, regardless of whether it is 

approved in a single-ingredient drug 

product, in a fixed-combination with 

another drug substance that contains no 

other previously approved active 

moiety, or in a fixed-combination with 

another drug substance that contains a 

previously approved active moiety. 

In the Federal Register of February 

24, 2014 (79 FR 10167), this guidance 

was published as a draft guidance. We 

have carefully reviewed and considered 

the comments that were received on the 

draft guidance. We have made editorial 

changes primarily for clarification. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on 5-year NCE 

exclusivity for certain fixedcombinations. 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 statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments 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, and 

will be posted to the docket at http://

www.regulations.gov. 

III. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collection of 

information in 21 CFR parts 314 have 

been approved under OMB control 

number 0910–0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES