42130 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

The burden for this information 

collection has changed since the last 

OMB approval. Our burden estimate 

reflects a decrease in burden by 14 

records and 112 hours. We attribute this 

adjustment to a decrease in the number 

of requests received over the last few 

years. 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17860 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3038] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Request for 

Samples and Protocols 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 September 

19, 2018. 

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 0910–0206. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Request for Samples and Protocols 

OMB Control Number 0910–0206— 

Extension 

This information collection supports 

Agency regulations. Under section 351 

of the Public Health Service Act (42 

U.S.C. 262), FDA has the responsibility 

to issue regulations that prescribe 

standards designed to ensure the safety, 

purity, and potency of biological 

products and to ensure that the 

biologics licenses for such products are 

only issued when a product meets the 

prescribed standards. Under § 610.2 (21 

CFR 610.2), the Center for Biologics 

Evaluation and Research (CBER) or the 

Center for Drug Evaluation and Research 

may at any time require manufacturers 

of licensed biological products to 

submit to FDA samples of any lot along 

with the protocols showing the results 

of applicable tests prior to distributing 

the lot of the product. In addition to 

§ 610.2, there are other regulations that 

require the submission of samples and 

protocols for specific licensed biological 

products: 21 CFR 660.6 (Antibody to 

Hepatitis B Surface Antigen); 21 CFR 

660.36 (Reagent Red Blood Cells); and 

21 CFR 660.46 (Hepatitis B Surface 

Antigen). 

Section 660.6(a) provides 

requirements for the frequency of 

submission of samples from each lot of 

Antibody to Hepatitis B Surface Antigen 

product, and § 660.6(b) provides the 

requirements for the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.6 products subject to official 

release by CBER, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After official release is no longer 

required, one sample along with a 

protocol is required to be submitted at 

90-day intervals. In addition, samples, 

which must be accompanied by a 

protocol, may at any time be required to 

be submitted to CBER if continued 

evaluation is deemed necessary. 

Section 660.36(a) requires, after each 

routine establishment inspection by 

FDA, the submission of samples from a 

lot of final Reagent Red Blood Cell 

product along with a protocol 

containing specific information. Section 

660.36(a)(2) requires that a protocol 

contain information including, but not 

limited to, manufacturing records, 

certain test records, and identity test 

results. Section 660.36(b) requires a 

copy of the antigenic constitution 

matrix specifying the antigens present 

or absent to be submitted to the CBER 

Director at the time of initial 

distribution of each lot. 

Section 660.46(a) contains 

requirements as to the frequency of 

submission of samples from each lot of 

Hepatitis B Surface Antigen product, 

and § 660.46(b) contains the 

requirements as to the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.46 products subject to official 

release by CBER, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

or manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After notification of official 

release is received, one sample along 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of the product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 79 

manufacturers submitted samples and 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42131 

protocols in fiscal year (FY) 2017, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 75 manufacturers 

submitted protocols under § 610.2 and 2 

manufacturers submitted protocols 

under the regulation (§ 660.6) for the 

other specific product. FDA received no 

submissions under §§ 660.36 or 660.46; 

however, FDA is using the estimate of 

one protocol submission under each 

regulation in the event that protocols are 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2017 for the various 

submission requirements of samples 

and protocols for the licensed biological 

products. The average burden per 

response is based on information 

provided by industry. The burden 

estimates provided by industry ranged 

from 1 to 5.5 hours. Under § 610.2, the 

hours per response are based on the 

average of these estimates and rounded 

to 3 hours. Under the remaining 

regulations, the average burden per 

response is based on the higher end of 

the estimate (rounded to 5 or 6 hours) 

since more information is generally 

required to be submitted in the other 

protocols than under § 610.2. 

In the Federal Register of May 11, 

2018, (83 FR 22081), we published a 

notice soliciting public comment of the 

information collection. No comments 

were received. 

We therefore estimate the burden of 

the information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.2—Requests for Samples and Protocols; Official Release ................................................................................. 75 86.267 6,470 3 19,410 

660.6(b)—Protocols ............................................................. 2 3.5 7 5 35 

660.36(a)(2) and (b)—Samples and Protocols .................... 1 1 1 6 6 

660.46(b)—Protocols ........................................................... 1 1 1 5 5 

Total .............................................................................. ........................ ........................ ........................ ........................ 19,456 

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

Our estimated burden for the 

information collection reflects an 

overall increase of 764 hours and a 

corresponding increase of 262 

responses. We attribute this adjustment 

to an increase in the number of 

submissions we received over the last 

few years. 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17859 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0438] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before September 19, 

2018. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–New–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Office of 

Adolescent Health Teen Pregnancy 

Prevention, FY 2015–2020 Performance 

Measure Collection. 

Type of Collection: Extension. 

OMB No. 0990–0438. 

Abstract: The Office of Adolescent 

Health (OAH), U.S. Department of 

Health and Human Services (HHS), is 

requesting renewal by OMB of the 

existing information collection request 

for performance measures collection 

from the TPP grant recipients. 

Performance measure data collection is 

a requirement of TPP grants; the 

extension will allow for the completion 

of data collection from cohort 2. The 

collection will provide OAH with 

performance data to inform planning 

decisions; identify technical assistance 

needs for grantees; facilitate grantees’ 

continuous quality improvement in 

program implementation; and provide 

HHS, Congress, OMB, and the general 

public with information about the 

individuals who participate in TPPfunded activities. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

Grant Recipient—Dissemination Form ...................................................... 84 2 15/60 42 

Grant Recipient—Partnerships Form ........................................................ 84 2 15/60 42 


daltland on DSKBBV9HB2PROD with NOTICES