64392 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 

1Please note that throughout the regulations 

referenced in relation to these information 

collections, licensed biological products refers to 

biologics licensed under any provision of section 

351 of the PHS Act. 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–25684 Filed 10–28–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0231] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adverse 

Experience Reporting for Licensed 

Biological Products; and General 

Records 

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 

28, 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 0910–0308. 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. 

Adverse Experience Reporting for 

Licensed Biological Products; and 

General Records—21 CFR Part 600— 

(OMB Control Number 0910–0308)— 

Extension 

Under the Public Health Service 

(PHS) Act (42 U.S.C. 262), FDA may 

only approve a biologics license 

application for a biological product that 

is safe, pure, and potent. When a 

biological product is approved and 

enters the market, the product is 

introduced to a larger patient 

population in settings different from 

clinical trials. New information 

generated during the postmarketing 

period offers further insight into the 

benefits and risks of the product, and 

evaluation of this information is 

important to insure its safe use. FDA 

issued the Adverse Experience 

Reporting (AER) requirements in part 

600 (21 CFR part 600) to enable FDA to 

take actions necessary for the protection 

of the public health in response to 

reports of adverse experiences related to 

licensed biological products.1

The primary purpose of FDA’s AER 

system is to identify potentially serious 

safety problems with licensed biological 

products. Although the premarket 

approval process is meant to disclose a 

general safety profile of a biological 

product’s comparatively common 

adverse effects, the larger and more 

diverse patient populations exposed to 

the licensed biological product provides 

the opportunity to collect information 

on rare, latent, and long-term effects. In 

addition, production and/or distribution 

problems have contaminated biological 

products in the past. AER reports are 

obtained from a variety of sources, 

including manufacturers, patients, 

physicians, foreign regulatory agencies, 

and clinical investigators. Identification 

of new and unexpected safety issues 

through the analysis of the data in AERS 

contributes directly to increased public 

health protection. For example, 

evaluation of these safety issues enables 

FDA to take focused regulatory action. 

Such action may include, but is not 

limited to, important changes to the 

product’s labeling (such as adding a 

new warning), coordination with 

manufacturers to ensure adequate 

corrective action is taken, and removal 

of a biological product from the market 

when necessary. 

Section 600.80(c)(1) requires licensed 

manufacturers or any person whose 

name appears on the label of a licensed 

biological product to report each 

adverse experience that is both serious 

and unexpected, whether foreign or 

domestic, as soon as possible but in no 

case later than 15 calendar days of 

initial receipt of the information by the 

licensed manufacturer. These reports 

are known as postmarketing 15-day 

Alert reports. This section also requires 

licensed manufacturers to submit any 

follow-up reports within 15 calendar 

days of receipt of new information or as 

requested by FDA, and if additional 

information is not obtainable, to 

maintain records of the unsuccessful 

steps taken to seek additional 

information. In addition, this section 

requires a person who submits an 

adverse action report to the licensed 

manufacturer, rather than FDA, to 

maintain a record of this action. 

Section 600.80(e) requires licensed 

manufacturers to submit a 15-day Alert 

report for an adverse experience 

obtained from a postmarketing clinical 

study only if the licensed manufacturer 

concludes that there is a reasonable 

possibility that the product caused the 

adverse experience. Section 600.80(c)(2) 

requires licensed manufacturers to 

report each adverse experience not 

reported in a postmarketing 15-day 

Alert report at quarterly intervals, for 3 

years from the date of issuance of the 

biologics license, and then at annual 

intervals. The majority of these periodic 

reports are submitted annually since a 

large percentage of currently licensed 

biological products have been licensed 

longer than 3 years. Section 600.80(i) 

requires licensed manufacturers to 

maintain for a period of 10 years records 

of all adverse experiences known to the 

licensed manufacturer, including raw 

data and any correspondence relating to 

the adverse experiences. Section 600.81 

requires licensed manufacturers to 

submit, at an interval of every 6 months, 

information about the quantity of the 

product distributed under the biologics 

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Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 64393 

license, including the quantity 

distributed to distributors. 

These distribution reports provide 

FDA with important information about 

products distributed under biologics 

licenses, including the quantity, certain 

lot numbers, labeled date of expiration, 

the fill lot numbers for the total number 

of dosage units of each strength or 

potency distributed (e.g., 50,000 per 10- 

milliliter vials), and date of release. FDA 

may require the licensed manufacturer 

to submit distribution reports under this 

section at times other than every 6 

months. Under § 600.90, a licensed 

manufacturer may submit a waiver 

request for any requirements that apply 

to the licensed manufacturer under 

§§ 600.80 and 600.81. A waiver request 

submitted under § 600.90 must include 

supporting documentation. 

Manufacturers of biological products 

for human use must keep records of 

each step in the manufacture and 

distribution of a product including any 

recalls. These recordkeeping 

requirements serve preventative and 

remedial purposes by establishing 

accountability and traceability in the 

manufacture and distribution of 

products. These requirements also 

enable FDA to perform meaningful 

inspections. Section 600.12 requires, 

among other things, that records must 

be made concurrently with the 

performance of each step in the 

manufacture and distribution of 

products. These records must be 

retained for no less than 5 years after the 

records of manufacture have been 

completed or 6 months after the latest 

expiration date for the individual 

product, whichever represents a later 

date. In addition, under § 600.12, 

manufacturers must maintain records 

relating to the sterilization of equipment 

and supplies, animal necropsy records, 

and records in cases of divided 

manufacturing responsibility with 

respect to a product. Under 

§ 600.12(b)(2), manufacturers are also 

required to maintain complete records 

pertaining to the recall from distribution 

of any product. Furthermore, § 610.18(b) 

requires, in part, that the results of all 

periodic tests for verification of cultures 

and determination of freedom from 

extraneous organisms be recorded and 

maintained. The recordkeeping 

requirements for §§ 610.12(g), 

610.13(a)(2), 610.18(d), 680.2(f) and 

680.3(f) are approved under OMB 

control number 0910–0139. 

Respondents to this collection of 

information include manufacturers of 

biological products and any person 

whose name appears on the label of a 

licensed biological product. In table 1, 

the number of respondents is based on 

the estimated number of manufacturers 

that are subject to those regulations or 

that submitted the required information 

to the Center for Biologics Evaluation 

and Research and Center for Drugs 

Evaluation and Research, FDA, in fiscal 

year (FY) 2013. Based on information 

obtained from FDA’s database system, 

there were 131 licensed biologics 

manufacturers. This number excludes 

those manufacturers who produce 

Whole Blood or components of Whole 

Blood and in vitro diagnostic licensed 

products, because of the exemption 

under § 600.80(k). The total annual 

responses are based on the number of 

submissions received by FDA in FY 

2013. There were an estimated 92,470 

15-day Alert reports, 132,667 periodic 

reports, and 334 lot distribution reports 

submitted to FDA. The number of 15- 

day Alert reports for postmarketing 

studies under § 600.80(e) is included in 

the total number of 15-day Alert reports. 

FDA received 64 requests from 35 

manufacturers for waivers under 

§ 600.90, of which 63 were granted. The 

hours per response are based on FDA 

experience. The burden hours required 

to complete the MedWatch Form for 

§ 600.80(c)(1), (e), and (f) are reported 

under OMB control number 0910–0291. 

In the Federal Register of April 7, 

2014 (79 FR 19097), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment; however, this comment did 

not address the information collection. 

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 

600.80(c)(1) and 600.80(e) .................................................. 131 705.88 92,470 1 92,470 

600.80(c)(2) .......................................................................... 131 1,012.73 132,667 28 3,714,676 

600.81 .................................................................................. 131 2.55 334 1 334 

600.90 .................................................................................. 35 1.83 64 1 64 

Total .............................................................................. ........................ ........................ ........................ ........................ 3,807,544 

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

In table 2, the number of respondents 

is based on the number of 

manufacturers subject to those 

regulations. Based on information 

obtained from FDA’s database system, 

there were 334 licensed manufacturers 

of biological products in FY 2013. 

However, the number of recordkeepers 

listed for § 600.12(a) through (e) 

excluding (b)(2) is estimated to be 164. 

This number excludes manufacturers of 

blood and blood components because 

their burden hours for recordkeeping 

have been reported under § 606.160 in 

OMB control number 0910–0116. The 

total annual records is based on the 

annual average of lots released in FY 

2013 (6,887), number of recalls made 

(1,679), and total number of adverse 

experience reports received (225,137) in 

FY 2013. The hours per record are based 

on FDA experience. 

FDA estimates the burden of this 

recordkeeping as follows: 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

600.12 2 ................................................................................ 164 41.99 6,887 32 220,384 

600.12(b)(2) ......................................................................... 334 5.03 1,679 24 40,296 

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64394 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

600.80(c)(1) and 600.80(i) ................................................... 131 1,718.60 225,137 1 225,137 

Total .............................................................................. ........................ ........................ ........................ ........................ 485,817 

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

2The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12. 

Dated: October 23, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25637 Filed 10–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1009] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Information 

Request Regarding pH of Smokeless 

Tobacco Products 

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 

28, 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–NEW and 

title ‘‘Information Request Regarding pH 

of Smokeless Tobacco Products.’’ 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. 

Information Request Regarding pH of 

Smokeless Tobacco Products—(OMB 

Control Number 0910–NEW) 

On June 22, 2009, President Obama 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by granting FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

generally and to reduce tobacco use by 

minors. 

Section 904(b) of the FD&C Act (21 

U.S.C. 387d(b)) states that at the request 

of the Secretary, each tobacco product 

manufacturer or importer, or agents 

thereof, must submit: 

• Any or all documents (including 

underlying scientific information) 

relating to research activities, and 

research findings, conducted, 

supported, or possessed by the 

manufacturer (or agents thereof) on the 

health, toxicological, behavioral, or 

physiological effects of tobacco products 

and their constituents (including smoke 

constituents), ingredients, components, 

and additives. 

• Any or all documents (including 

underlying scientific or financial 

information) relating to research 

activities, and research findings, 

conducted, supported, or possessed by 

the manufacturer (or agents thereof) that 

relate to the issue of whether a 

reduction in risk to health from tobacco 

products can occur upon the 

employment of technology available or 

known to the manufacturer. 

• Any or all documents (including 

underlying scientific or financial 

information) relating to marketing 

research involving the use of tobacco 

products or marketing practices and the 

effectiveness of such practices used by 

tobacco manufacturers and distributors. 

If the Secretary requests information 

from the manufacturer of a tobacco 

product not manufactured in the United 

States, the importer of the tobacco 

product is required to supply the 

information. FDA is requesting OMB 

approval of an information collection 

under section 904(b) of the FD&C Act. 

To become better informed about the 

impact of the use of tobacco products on 

the public health, FDA would request 

information about the effects of product 

pH in smokeless tobacco products from 

all tobacco product manufacturers. FDA 

would send letters to tobacco product 

manufacturers and importers who FDA 

has identified as having an obligation to 

respond based on information before the 

Agency. The requested information 

would include information about 

research requested under section 904(b) 

of the FD&C Act as well as information 

to be provided voluntarily beyond the 

inquiries described in section 904(b). 

I. Information Requested 

The proposed request would include 

the following information: 

All documents (including underlying 

scientific information and financial 

information) relating to research 

activities and research findings 

conducted, supported, or possessed by 

the respondent or the respondent’s 

agents relating to a specified set of 

topics listed in this document. The 

request includes but is not limited to 

documents relating to research findings 

and activities, if any, that the 

respondent possesses as the result of 

acquiring or merging with another 

company. For purposes of the request, 

‘‘research’’ would include, but would 

not be limited to, focus groups, surveys, 

experimental clinical studies, 

toxicological and biochemical assays, in 

vivo and in vitro assays including 

animal testing, laboratory formulation 

and processing testing, taste panels, and 

assessments of the effectiveness of 

product marketing practices. The 

request would apply to research relating 

to any and all smokeless tobacco 

products, including but not limited to 

those products for research, 

investigational use, developmental 

studies, test marketing, and/or 

commercial marketing, and also to the 

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