Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 4931 

TABLE 2—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 

Contact lens cleaning solution labeling—800.10(a)(3) and 

800.12(c) ........................................................................ 17 8 136 1 136 

Liquid ophthalmic preparation labeling—800.10(b)(2) ....... 17 8 136 1 136 

Manufacturer, packer, or distributor information—801.1 ... 13,780 7 96,460 1 96,460 

Adequate directions for use—801.5 .................................. 6,657 6 39,942 22.35 892,704 

Statement of identity—801.61 ........................................... 6,657 6 39,942 1 39,942 

Declaration of net quantity of contents—801.62 ............... 6,657 6 39,942 1 39,942 

Prescription device labeling—801.109 .............................. 7,558 6 45,348 17.77 805,834 

Retail exemption for prescription devices—801.110 ......... 30,000 667 20,010,000 0.25 5,002,500 

Processing, labeling, or repacking; non-sterile devices— 

801.150(e) ...................................................................... 377 34 12,818 4 51,272 

Labeling of articles intended for lay use in the repairing 

and/or refitting of dentures—801.405(b)(1) .................... 31 1 31 4 124 

Dentures; information regarding temporary and emergency use—801.405(c) .................................................. 31 1 31 4 124 

Labeling requirements for hearing aids—801.420(c)(1) .... 86 12 1,032 40 41,280 

Technical data for hearing aids—801.420(c)(4) ................ 86 12 1,032 80 82,560 

Hearing aids, opportunity to review user instructional brochure—801.421(b) .......................................................... 10,000 160 1,600,000 0.30 480,000 

Hearing aids, availability of user instructional brochure— 

801.421(c) ...................................................................... 10,000 5 50,000 0.17 8,500 

User labeling for menstrual tampons—801.430(d) ............ 22 8 176 2 352 

Menstrual tampons, ranges of absorbency— 

801.430(e)(2) .................................................................. 22 8 176 2 352 

User labeling for latex condoms—801.435(b), (c), and (h) 63 6 378 100 37,800 

Labeling for IVDs—809.10(a) and (b) ............................... 1,700 6 10,200 80 816,000 

Labeling for general purpose laboratory reagents— 

809.10(d)(1) .................................................................... 300 2 600 40 24,000 

Labeling for analyte specific reagents—809.10(e) ............ 300 25 7,500 1 7,500 

Labeling for OTC test sample collection systems for 

drugs of abuse testing—809.10(f) .................................. 20 1 20 100 2,000 

Advertising and promotional materials for ASRs— 

809.30(d) ........................................................................ 300 25 7,500 1 7,500 

Labeling of sunlamp products—1040.20(d) ....................... 30 1 30 10 300 

Total ............................................................................ ........................ .......................... ........................ ........................ 8,437,318 

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

Dated: January 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01668 Filed 1–28–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0509] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Appeals of 

Science-Based Decisions Above the 

Division Level at the Center for 

Veterinary Medicine 

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 March 2, 

2015. 

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 0910–0566. 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. 

Appeals of Science-Based Decisions 

Above the Division Level at CVM—21 

CFR 10.75 (OMB Control Number 0910– 

0566—Revision) 

Respondents: Respondents to this 

collection of information are applicants 

that wish to submit a request for review 

of a scientific dispute. 

The Center for Veterinary Medicine’s 

(CVM’s) guidance for industry #79 

entitled ‘‘Dispute Resolution Procedures 

for Science-Based Decisions on Products 

Regulated by the Center for Veterinary 

Medicine,’’ describes the process by 

which CVM formally resolves disputes 

relating to scientific controversies. A 

scientific controversy involves issues 

concerning a specific product regulated 

by CVM related to matters of technical 

expertise and requires specialized 

education, training, or experience to be 

understood and resolved. Further, the 

mstockstill on DSK4VPTVN1PROD with NOTICES

4932 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 

guidance details information on how the 

Agency intends to interpret and apply 

provisions of the existing regulations 

regarding internal Agency review of 

decisions. In addition, the guidance 

outlines the established procedures for 

persons who are sponsors, applicants or 

manufacturers, for animal drugs or other 

products regulated by CVM, that wish to 

submit a request for review of a 

scientific dispute. When a sponsor, 

applicant, or manufacturer has a 

scientific disagreement with a written 

decision by CVM, they may submit a 

request for a review of that decision by 

following the established Agency 

channels of supervision for review. 

In the Federal Register of November 

6, 2014 (79 FR 65976), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

but it did not respond to any of the four 

collection of information topics 

solicited in the notice and therefore is 

not discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.75 .................................................................................... 2 4 8 10 80 

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

CVM encourages applicants to begin 

the resolution of science-based disputes 

with discussions with the review team/ 

group, including the Team Leader or 

Division Director. The Center prefers 

that differences of opinion regarding 

science or science-based policy be 

resolved between the review team/group 

and the applicant. If the matter is not 

resolved by this preferred method, then 

CVM recommends that the applicant 

follow the procedure in guidance for 

industry #79. Of the two respondents 

who were advised on the procedure 

during the past 3 years, one has not 

followed up to initiate it and the other 

is working with the review team/group 

to resolve the issue(s). Therefore, this 

estimated annual reporting burden is 

based on CVM’s previous experience in 

handling formal appeals for scientific 

disputes. 

Dated: January 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01669 Filed 1–28–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1069] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Blood 

Establishment Registration and 

Product Listing 

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 March 2, 

2015. 

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 0910–0052. 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. 

Blood Establishment Registration and 

Product Listing, Form FDA 2830—21 

CFR Part 607 (OMB Control Number 

0910–0052)—Extension 

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360), any person owning or operating an 

establishment that manufactures, 

prepares, propagates, compounds, or 

processes a drug or device must register 

his or her name, place of business, and 

all such establishments with the 

Secretary of Health and Human Services 

on or before December 31 of each year. 

He or she must also submit, among 

other information, a listing of all drug or 

device products manufactured, 

prepared, propagated, compounded, or 

processed by him or her for commercial 

distribution. In part 607 (21 CFR part 

607), FDA has issued regulations 

implementing these requirements for 

manufacturers of human blood and 

blood products. 

Section 607.20(a), in brief, requires 

owners or operators of certain 

establishments that engage in the 

manufacture of blood products to 

register and to submit a list of every 

blood product in commercial 

distribution. 

Section 607.21, in brief, requires the 

owners or operators of establishments 

entering into the manufacturing of blood 

products to register within 5 days after 

beginning such operation and to submit 

a list of every blood product in 

commercial distribution at the time. If 

the owner or operator of the 

establishment has not previously 

entered into such operation for which a 

license is required, registration must 

follow within 5 days after the 

submission of a biologics license 

application. In addition, owners or 

operators of all establishments so 

engaged must register annually between 

November 15 and December 31 and 

update their blood product listing every 

June and December. 

Section 607.22 requires the use of 

Form FDA 2830, Blood Establishment 

Registration and Product Listing, for 

initial registration, for subsequent 

annual registration, and for blood 

product listing information. 

Section 607.25 sets forth the 

information required for establishment 

registration and blood product listing. 

Section 607.26, in brief, requires 

certain changes to be submitted on FDA 

Form 2830 as an amendment to 

mstockstill on DSK4VPTVN1PROD with NOTICES