Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices 50365 

In addition, for evaluation of novel 

excipients with a proposed use in 

formulations for biological drug 

products reviewed by CDER/OND, 

submitters should provide: 

• Stability studies of the excipient 

under storage and potential in-use 

conditions (e.g., over infusion time). 

Novel excipients should be evaluated 

for their potential to prevent 

denaturation and degradation of 

proteins during storage. 

• For some excipients, studies should 

address their potential protein-excipient 

interaction and impact on drug product 

immunogenicity as well as their 

potential for masking process related 

impurities. 

Full packages should be submitted 

through a Type V DMF or other master 

file no later than 3 months after 

notification that FDA has selected the 

proposal. For more information on 

submitting Type V DMFs, see the FDA 

draft guidance for industry entitled 

‘‘Drug Master Files’’ (Ref. 8). 

FDA will evaluate the full package 

and determine whether the excipient is 

appropriate for the proposed use for use 

in clinical trials. FDA will issue a letter 

to the novel excipient submitter 

announcing its decision. 

For each novel excipient evaluated 

under the second stage of the program, 

FDA will publish on the Pilot Program 

web page the initial proposal and the 

determination letter. Information that 

cannot be publicly disclosed will be 

redacted. This web page will also 

include a content outline identifying 

information that should be included in 

an Initial Proposal and other relevant 

information regarding the pilot. 

3. Effect of Determination 

A determination that the excipient is 

appropriate for use in clinical trials 

means that FDA has determined it is 

appropriate to use the novel excipient in 

an IND within the defined use without 

additional justification. However, the 

drug sponsor would still need to 

demonstrate that the excipient is safe in 

the proposed formulation. The 

information submitted under the full 

package would remain in the Type V 

DMF or other master file, and the master 

file holder may grant authorization to 

reference the information in the master 

file at the holder’s discretion. Moreover, 

we do not anticipate that a novel 

excipient may be used in an abbreviated 

new drug application because data and 

information currently required to 

support use of a novel excipient may 

not be submitted in an abbreviated new 

drug application. After it has been used 

in approved drug products, the novel 

excipient would be added to the 

Inactive Ingredient Database in 

accordance with Agency practice. 

If FDA determines that the excipient 

is not appropriate for the proposed use, 

an IND sponsor would be expected to 

provide additional information to 

demonstrate that the use of the novel 

excipient is appropriate within the 

context of the IND. 

II. Paperwork Reduction Act of 1995 

The information collection activities 

associated with the Pilot Program refer 

to previously approved FDA collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this Pilot 

Program. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in 21 CFR 

part 314 pertaining to the submission of 

abbreviated new drug applications, new 

drug applications, and DMFs have been 

approved under OMB control number 

0910–0001. The collections of 

information in 21 CFR part 312 

pertaining to the submission of IND 

content and format; chemistry, control, 

and manufacturing data; pharmacology 

and toxicology data; and 

pharmacokinetics and biological data 

have been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 58 

pertaining to good laboratory practice 

regulations for nonclinical laboratory 

studies have been approved under OMB 

control number 0910–0119. The 

collections of information in 21 CFR 

part 601 pertaining to biologics license 

applications have been approved under 

OMB control number 0910–0338. 

III. References 

The following references are on 

display at the Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, and are available for viewing by 

interested persons between 9 a.m. and 4 

p.m., Monday through Friday; they are 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, Guidance for Industry, ‘‘Nonclinical 

Studies for the Safety Evaluation of 

Pharmaceutical Excipients,’’ May 2005 

(available at https://www.fda.gov/media/ 

72260/download). For the most recent 

version of a guidance, check the FDA 

guidance web page at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

2. FDA Guidance for Industry, ‘‘S7A Safety 

Pharmacology Studies for Human 

Pharmaceuticals,’’ July 2001 (available at 

https://www.fda.gov/media/72033/ 

download). 

3. FDA, Guidance for Industry, ‘‘M3(R2) 

Nonclinical Safety Studies for the 

Conduct of Human Clinical Trials and 

Marketing Authorization for 

Pharmaceuticals,’’ January 2010 

(available at https://www.fda.gov/media/ 

71542/download). 

4. FDA, Guidance for Industry, ‘‘S2B 

Genotoxicity: A Standard Battery for 

Genotoxicity Testing of 

Pharmaceuticals,’’ July 1997 (available at 

https://www.fda.gov/media/71971/ 

download). 

5. International Council for Harmonization 

(ICH), Guidance for Industry, ‘‘Detection 

of Reproductive and Developmental 

Toxicity for Human Pharmaceuticals 

S5(R3),’’ February 2020 (available at 

https://database.ich.org/sites/default/ 

files/S5-R3_Step4_Guideline_2020_

0218_1.pdf). 

6. FDA, Guidance for Industry, ‘‘The Need for 

Long-term Rodent Carcinogenicity 

Studies of Pharmaceuticals,’’ March 1996 

(available at https://www.fda.gov/media/ 

71921/download). 

7. FDA, Guidance for Industry, ‘‘S8 

Immunotoxicity Studies for Human 

Pharmaceuticals,’’ April 2006 (available 

at https://www.fda.gov/media/72047/ 

download). 

8. FDA, Draft Guidance for Industry ‘‘Drug 

Master Files,’’ October 2019 (available at 

https://www.fda.gov/media/131861/ 

download). 

Dated: September 1, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19335 Filed 9–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: MCH 

Jurisdictional Survey Instrument for 

the Title V MCH Block Grant Program, 

OMB No. 0906–0042, Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 for opportunity 

for public comment on proposed data 

collection projects, HRSA announces 


jbell on DSKJLSW7X2PROD with NOTICES
50366 Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, or any other aspect of the ICR 

related to the Maternal and Child Health 

(MCH) Jurisdictional Survey that is to be 

administered in the U.S. territories and 

jurisdictions (excluding the District of 

Columbia) for purposes of collecting 

information related to the well-being of 

all mothers, children, and their families. 

DATES: Comments on this Information 

Collection Request must be received no 

later than November 8, 2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

MCH Jurisdictional Survey Instrument 

for the Title V MCH Block Grant 

Program, OMB No. 0906–0042, 

Extension. 

Abstract: The purpose of the Title V 

MCH Block Grant is to improve the 

health of the nation’s mothers, infants, 

children, including children with 

special health care needs, and their 

families by creating federal/state 

partnerships that provide each state/ 

jurisdiction with needed flexibility to 

respond to its individual MCH 

population needs. Unique to the MCH 

Block Grant is a commitment to 

performance accountability, while 

assuring state flexibility. Utilizing a 

three-tiered national performance 

measure framework, which includes 

National Outcome Measures, National 

Performance Measures, and EvidenceBased and Informed Strategy Measures, 

State Title V programs report annually 

on their performance relative to the 

selected national performance and 

outcome measures. Such reporting 

enables the state and federal program 

offices to assess the progress achieved in 

key MCH priority areas and to 

document Title V program 

accomplishments. 

By legislation (Sections 505(a) and 

506(a) of Title V of the Social Security 

Act), the MCH Block Grant Application/ 

Annual Report must be developed by, or 

in consultation with, the State MCH 

Health agency. In establishing state 

reporting requirements, HRSA’s 

Maternal and Child Health Bureau 

considers the availability of national 

data from other federal agencies. Data 

for the national performance and 

outcome measures are pre-populated for 

states in the Title V Information System. 

National data sources identified for the 

National Performance Measures and 

National Outcome Measures in the MCH 

Block Grant program seldom include 

data from the Title V jurisdictions, with 

the exception of the District of 

Columbia. The eight remaining 

jurisdictions (i.e., American Samoa, 

Federated States of Micronesia, Guam, 

Marshall Islands, Northern Mariana 

Islands, Palau, Puerto Rico and U.S. 

Virgin Islands) have limited access to 

significant data and MCH indicators, 

with limited capacity for collecting 

these data. 

Sponsored by HRSA’s Maternal and 

Child Health Bureau, the MCH 

Jurisdictional Survey is designed to 

produce data on the physical and 

emotional health of mothers and 

children under 18 years of age in the 

following eight jurisdictions—American 

Samoa, Federated States of Micronesia, 

Guam, Marshall Islands, Northern 

Mariana Islands, Palau, Puerto Rico, and 

Virgin Islands. More specifically, the 

MCH Jurisdictional Survey collects 

information on factors related to the 

well-being of children, including health 

status, visits to health care providers, 

health care costs, and health insurance 

coverage. In addition, the MCH 

Jurisdictional Survey collects 

information on factors related to the 

well-being of mothers, including health 

risk behaviors, health conditions, and 

preventive health practices. This data 

collection enables the jurisdictions to 

meet federal performance reporting 

requirements and to demonstrate the 

impact of Title V funding relative to 

MCH outcomes for the U.S. jurisdictions 

in reporting on their unique MCH 

priority needs. 

The MCH Jurisdictional Survey was 

designed based on informationgathering activities with Title V 

leadership and program staff in the 

jurisdictions, experts at the Centers for 

Disease Control and Prevention and 

other organizations with relevant data 

collection experience. Survey items are 

based on the National Survey of 

Children’s Health; the Behavioral Risk 

Factor Surveillance System; the Youth 

Behavior Surveillance System; and 

selected other federal studies. The 

Survey is designed as a core 

questionnaire to be administered across 

all jurisdictions with a supplemental set 

of survey questions customized to the 

needs of each jurisdiction. 

Need and Proposed Use of the 

Information: Data from the MCH 

Jurisdictional Survey is used to measure 

progress on national performance and 

outcome measures under the Title V 

MCH Block Grant Program. This survey 

instrument is critical to collect 

information on factors related to the 

well-being of all mothers, children, and 

their families in the jurisdictional Title 

V programs, which address their unique 

MCH needs. 

Likely Respondents: The respondent 

universe is women age 18 or older who 

live in one of the eight targeted U.S. 

jurisdictions (Puerto Rico, U.S. Virgin 

Islands, Guam, Northern Mariana 

Islands, American Samoa, Palau, 

Marshall Islands, or Federated States of 

Micronesia) and who are mothers or 

guardians of at least one child aged 

0–17 years living in the same 

household. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. Included is the time needed 

to review instructions; to develop, 

acquire, install, and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices 50367 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Burden hours 

per form 

Total 

burden hours 

Adult Parents—Puerto Rico .. Screener ................................ 2,480 1 2,480 0.03 74.40 299.40 

Core ....................................... 250 1 250 0.83 207.50 

Jurisdiction Module ............... 250 1 250 0.07 17.50 

Adult Parents—U.S. Virgin Islands.Screener ................................

Core .......................................

2,153 

250 

1 

1 

2,153 

250 

0.03 

0.83 

64.59 

207.50 

289.59 

Jurisdiction Module ............... 250 1 250 0.07 17.50 

Adult Parents—Guam ........... Screener ................................ 684 1 684 0.03 20.52 245.52 

Core ....................................... 250 1 250 0.83 207.50 

Jurisdiction Module ............... 250 1 250 0.07 17.50 

Adult Parents—American 

Samoa.

Screener ................................

Core .......................................

426 

250 

1 

1 

426 

250 

0.03 

0.83 

12.78 

207.50 

232.78 

Jurisdiction Module ............... 250 1 250 0.05 12.50 

Adult Parents—Federated 

States of Micronesia.

Screener ................................

Core .......................................

339 

250 

1 

1 

339 

250 

0.03 

0.83 

10.17 

207.50 

230.17 

Jurisdiction Module ............... 250 1 250 0.05 12.50 

Adult Parents—Marshall Islands.Screener ................................

Core .......................................

284 

250 

1 

1 

284 

250 

0.03 

0.83 

8.52 

207.50 

236.02 

Jurisdiction Module ............... 250 1 250 0.08 20.00 

Adult Parents—Northern Mariana Islands.Screener ................................

Core .......................................

470 

250 

1 

1 

470 

250 

0.03 

0.83 

14.10 

207.50 

241.60 

Jurisdiction Module ............... 250 1 250 0.08 20.00 

Adult Parents—Palau ............ Screener ................................ 467 1 467 0.03 14.01 226.51 

Core ....................................... 250 1 250 0.83 207.50 

Jurisdiction Module ............... 250 1 250 0.02 5.00 

Total ............................... ................................................ 7,303 ........................ 7,303 ........................ ........................ 2,001.59 

HRSA specifically requests comments 

on (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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–19447 Filed 9–7–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Evaluation of 

Office of Acquisitions System (OASYS) 

and FFRDC Contract Administration 

System (FCAS) Vendor Portals 

National Cancer Institute (NCI); 

Correction 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Department of Health and 

Human Services, National Institutes of 

Health published a Notice in the 

Federal Register on August 31, 2021. 

That Notice requires a correction in the 

SUPPLEMENTARY INFORMATION section. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Marla Jacobson, 9609 Medical Center 

Drive, MSC 9742, Rockville, MD 20850 

or call non-toll-free number 240–276– 

5267 or email your request, including 

your address to: marla.jacobson@

nih.gov. Formal requests for additional 

plans and instruments must be 

requested in writing. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of August 31, 

2021, in FR Doc. 2021–18767, on page 

48747, as found within the 

SUPPLEMENTARY INFORMATION section, 

within the Estimated Annualized 

Burden Hours table for the Total Annual 

Burden Hours for the form name 

column Survey—FCAS total currently 

reads ‘‘1’’ and is corrected to read: ‘‘0’’, 

the form name column Registration— 

FCAS total currently reads ‘‘1’’ and is 

corrected to read: ‘‘0’’. These corrections 

revise the Total Annual Burden Hours 

total currently reads ‘‘232’’ and is 

corrected to read: ‘‘230’’. 

Dated: September 1, 2021. 

Diane Kreinbrink, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2021–19281 Filed 9–7–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Minority Health 

and Health Disparities; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 


jbell on DSKJLSW7X2PROD with NOTICES